Monitoring –Backlog

MA- Monitoring-Expired

Back to Dashboard

No. Reference No. Brand Name Generic Name GMP Status Assessment Pathway Application Date Application Stage Time monitor
17928/2017SAPHIR INFANTSAMOXICILLIN & CLAVULANIC ACID NOT APPLIED FULL ASSESSMENT Pending GMP 19,864
2RWANDA-FDA24/HM/0270Normopress Tablet 25mgLosartan Potassium USP FULL ASSESSMENT Not Assessed19,864
3RWANDA-FDA24/HM/0271Normozide Tablet 12.5/50mgLosartan potassium & hydrochlorothiazde tablets USP 50mg/12.5 mg FULL ASSESSMENT Not Assessed19,864
4RWANDA-FDA24/HM/0272Noclot -EA Tablet 75/75mgClopidogrel 75mg & Aspirin 75mg FULL ASSESSMENT Not Assessed19,864
5RWANDA-FDA24/HM/0251SUPPOL 125Acetaminaophen Suppositories USP 125mg FULL ASSESSMENT Not Assessed19,864
6RWANDA-FDA24/HM/0189FENSUPP 100DICLOFENAC SODIUM SUPPOSITORIES FULL ASSESSMENT Not Assessed19,864
7RWANDA-FDA24/HM/0246Suppol 250Acetaminophen Suppositories USP 250mg FULL ASSESSMENT Not Assessed19,864
8RWANDA-FDA23/HM/0589AgofenIBUPROFEN ORAL SUSPENSION FULL ASSESSMENT Not Assessed19,864
9RWANDA-FDA24/HM/0293TRIMAGO TABLETSCo-trimoxazole Tablets BP FULL ASSESSMENT Not Assessed19,864
10RWANDA-FDA24/HM/0305TERAFINE TABLETSTerbinafine Tablets 250 mg FULL ASSESSMENT Not Assessed19,864
11RWANDA-FDA24/HM/0308TRIMAGO-DS TABLETSCo-trimoxazole Tablets BP FULL ASSESSMENT Not Assessed19,864
12RWANDA-FDA24/HM/0264TETAVINTETANUS ANTITOXIN 1500 I.U. B.P. (1.0 mL LIQUID AMPOULE) FULL ASSESSMENT Not Assessed19,864
13DANDASHA 20MG F/C TABLETTADALAFIL NOT APPLIED FULL ASSESSMENT To Update Dossier19,864
14LAMIVUDINE AND ZIDOVUDINE TABLETS USPLAMIVUDINE AND ZIDOVUDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT To Update Dossier19,864
15PRAZICIDE TABLETSPRAZIQUANTEL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT To Update Dossier19,864
16SOHIVEPSOFOSBUVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT To Update Dossier19,864
1711458/2021MOVFORMOLNUPIRAVIR APPLIED FOR GMP RECOGNITION Peer Review19,864
18RWANDA-FDA23/HM/0004BRUFENIBUPROFENE FULL ASSESSMENT Not Assessed19,864
19RWANDA-FDA23/HM/0500EPIDERM CREAM 15 & 30 GMBetamethasone Dipropionate, Gentamicin Sulphate, Tolnaftate and Iodochlorhydroxyquinoline Cream. FULL ASSESSMENT Not Assessed19,864
20RWANDA-FDA23/HM/0465DIAZAC M ER 5/1000Dapagliflozin 5 mg and Metformin Hydrochloride USP 1000 mg Tablets FULL ASSESSMENT Not Assessed19,864
21RWANDA-FDA23/HM/0467DIAZAC M ER 10/500Dapagliflozin 10 mg and Metformin Hydrochloride 500 mg FULL ASSESSMENT Not Assessed19,864
22RWANDA-FDA23/HM/0466DIAZAC M ER 10/1000Dapagliflozin 10 mg and Metformin Hydrochloride 1000 mg FULL ASSESSMENT Not Assessed19,864
23RWANDA-FDA23/HM/0587SiropilDolutegravir/ Lamivudine/Tenofovir Disoproxil Fumarate Tablets, 50mg/300 mg/ 300 mg FULL ASSESSMENT Not Assessed19,864
24RWANDA-FDA24/HM/0024Levosalbutamol Tartrate Inhalation Aerosol FULL ASSESSMENT Not Assessed19,864
25RWANDA-FDA23/HM/0260Duxcospan Plus TabletsHyoscine butyl bromide and Paracetamol FULL ASSESSMENT Not Assessed19,864
26RWANDA-FDA24/HM/0023CYVACR21 Malaria Vaccine (Recombinant, Adjuvanted) FULL ASSESSMENT Not Assessed19,864
27Rwanda FDA23-HM-0214LEVETIRACETAM UCB 500 MG FILM-COATED TABLETS Levetiracetam 500 mg FULL ASSESSMENT Not Assessed19,864
28Rwanda FDA-HMP-MA-0929MORPHINE SULPHATE- FRESENIUS PFMorphine Sulphate 15 mg/1 ml FULL ASSESSMENT Not Assessed19,864
29RWANDA-FDA24/HM/0135Momate NSMometasone Furoate Monohydrate Nasal Spray 50 mcg FULL ASSESSMENT Not Assessed19,864
30RWANDA-FDA24/HM/0257FLOXIMEXMoxifloxacin Ophthalmic Solution USP 0.5 % w/v FULL ASSESSMENT Not Assessed19,864
31RWANDA-FDA23/HM/0596SURDEX KIDSParacetamol, Pheniramine Maleate & Ascorbic acid granules for oral solution FULL ASSESSMENT Not Assessed19,864
32RWANDA-FDA24/HM/0155AZIREN TABLETSAzithromycin Dihydrate FULL ASSESSMENT Not Assessed19,864
33RWANDA-FDA24/HM/0157RENETRIM SUSPENSIONSulfamethoxazole BP 200 mg and Trimethoprim BP 40 mg FULL ASSESSMENT Not Assessed19,864
34RWANDA-FDA24/HM/0159ERYTHROREN SUSPENSIONErythromycin Estolate FULL ASSESSMENT Not Assessed19,864
35RWANDA-FDA24/HM/0165PAINEX TABLETSParacetamol 500mg, Aspirin 500mg and Caffeine anhydrous 50mg FULL ASSESSMENT Not Assessed19,864
36RWANDA-FDA24/HM/0080MEDICAINEMepivacaine hydrochloride FULL ASSESSMENT Not Assessed19,864
37RWANDA-FDA24/HM/0256Sitamet tablets 50/500 mgSitagliptin Phosphate Monohydrate 50 mg and Metformin Hydrochloride USP 500 mg FULL ASSESSMENT Not Assessed19,864
38Via emailHydroxyurea 1000 HGCHydroxyurea 1000 mg GMP CERTIFICATE AVAILABLE RECOGNITION 0000-00-00Peer Review739,424
39Via emailHydroxyurea 100 HGCHydroxyurea 100 mg GMP CERTIFICATE AVAILABLE RECOGNITION 0000-00-00Peer Review739,424
401361/2018NEVIHUANEVIRAPINE NOT APPLIED FULL ASSESSMENT 0000-00-00Pending 2st Assessment, ADD.DATA739,424
4113373/2018ARBITEL H-80TELMISARTAN AND HYDRCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE RECOGNITION 2017-09-26Peer Review2,429
4215831/2017BEKRAZOL 200/5ALBENDAZOLE BP APPLIED FOR GMP ABRIDGED 2017-11-13Not Assessed2,381
4315831/2017BEKRAZOL 400ALBENDAZOLE 400MG USP APPLIED FOR GMP ABRIDGED 2017-11-13Not Assessed2,381
4413971/2018FEVAROL 500/5/5/2/30PARACETAMOL CAFFEINE, PHENYLEPHRINE, CHLORPHENIRAMINE APPLIED FOR GMP ABRIDGED 2018-01-10Pending 2st Assessment2,323
45589/2018CAPEMAX 500CAPECITABINE GMP CERTIFICATE AVAILABLE RECOGNITION 2018-01-15Peer Review2,318
4613973/2018SELVAREN 400SEVELAMER CARBONATE APPLIED FOR GMP FULL ASSESSMENT 2018-02-10Not Assessed2,292
478727/2017KCHEKCALCIUM POLYSTYRENE SULFONATE APPLIED FOR GMP FULL ASSESSMENT 2018-02-10Pending 1st Assessment2,292
4813966/2018BEKRACINE 200CEFIXIME APPLIED FOR GMP ABRIDGED 2018-02-10Peer Review2,292
4913956/2018PILL-72LEVONORGESTREL APPLIED FOR GMP ABRIDGED 2018-02-10Peer Review2,292
5013965/2018SEKALGIC 500/400/30PARACETAMOL/IBUPROFEN/CAFFEINE APPLIED FOR GMP ABRIDGED 2018-02-10Peer Review2,292
51090/2018MYCOREN 100000UINYSTATIN NOT APPLIED ABRIDGED 2018-02-11Peer Review2,291
52087/2018RENESTEN -VCLOTRIMAZOLE APPLIED FOR GMP ABRIDGED 2018-02-11Peer Review2,291
53043-2018OXYTOCIN INJECTIONOXYTOCIN BP 10IU/ML APPLIED FOR GMP ABRIDGED 2018-02-15Peer Review2,287
5414800/2018ENTAMIZOLE DS 500/400MGDILOXAMIDE FUROATE & MENOTRONIDAZOLE NOT APPLIED ABRIDGED 2018-02-20To Update Dossier2,282
5514798/2018ENTAMIZOLE SS 30'SDILOXAMIDE FUROATE & MENOTRONIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-02-20To Update Dossier2,282
562468/2018SERC-8BETAHISTINE DIHYDROCHLORIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-02-21Peer Review2,281
572466/2018ENTAMIZOLE DS 15'SDILOXAMIDE FUROATE & MENOTRONIDAZOLE GMP CERTIFICATE AVAILABLE RECOGNITION 2018-02-21To Update Dossier2,281
585424/2018FEMIGESTON-200PROGESTERONE BP APPLIED FOR GMP FULL ASSESSMENT 2018-02-27Not Assessed2,275
595856/2018V-IMMUNEHuman Normal Immunoglobulin for Intravenous Administration B.P 5 % NOT APPLIED ABRIDGED 2018-03-05To Update Dossier2,269
605904/2018GEMLEEGemcitabine Hydrochloride NOT APPLIED FULL ASSESSMENT 2018-03-05Not Assessed2,269
61348/2018CLEAR T GEL CLINDAMYCIN PHOSPHATE USP+ TRETINOIN USP GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
62345-2018DOBESIL 5X10 TABCALCIUM DOBESILATE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
63353-2018DOBESIL H CREAM 30 GRMCALCIUM DOBESILATE + HYDROCORTISONE + LIGNOCAINE + ZINC OXIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
64347-2018FINACE MR TAB 2X10 TABACECLOFENAC GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
65346/2018TX-MF TAB 5X6 GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-03-12Not Assessed2,262
66352-2018FINACE PLUS 3X10 TABACECLOFENAC/PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
67358/2018TACROVATE FORTE OINTMENTTACROLIMUS USP GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
68350/2018TACROVATE OINTMENTTACROLIMUS USP GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
69341/2018TORICOX -120ETORICOXIB GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
70344/2018TORICOX -PLUS ETORICOXIB +PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
71343/2018TORICOX-90ETORICOXIB GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
72357/2018INTRAZ TAB 1X4 TABITRACONAZOLE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
73351/2018LACX SYRUP 100 MLLACTULOSE SOLUTION USP GMP CERTIFICATE AVAILABLE ABRIDGED 2018-03-12To Update Dossier2,262
74379/2018C-ZOLE BG CLOTRIMAZOLE+BECLOMETHAZONE DIPROPIONATE+GENTAMYCIN SULPHATE APPLIED FOR GMP ABRIDGED 2018-05-12To Update Dossier2,201
75382/2018TINEAHIT LULICONAZOLE NOT APPLIED FULL ASSESSMENT 2018-05-12Not Assessed2,201
76380/2018TERBIBACT MIXITERBINAFINE HYDROCHLORIDE+OFLOXACIN+ORNIDAZOLE+CLOBETASOL PROPIONATE NOT APPLIED FULL ASSESSMENT 2018-05-12Not Assessed2,201
77406-2018MORCET-10ESCITALOPRAM APPLIED FOR GMP ABRIDGED 2018-06-122nd Assessment Completed 2,170
78407-2018MORCET-20ESCITALOPRAM APPLIED FOR GMP ABRIDGED 2018-06-122nd Assessment Completed 2,170
79405-2018VITALIPID NOVUM ADULT RETINOL PALMITATE, PHYTOMENADIONE, ERGOCALCIFEROL, DL-?-TOCOPHEROL APPLIED FOR GMP RECOGNITION 2018-06-12Peer Review2,170
8011073-2018FEBLILEX PARACETAMOL 500MG,CHLORPHENIRAMINE 2MG, PHENYLEPHRINE 5MG APPLIED FOR GMP ABRIDGED 2018-08-10To Update Dossier2,111
81117071/2018LATANASOLLATANOPROST GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-08-10Pending 1st Assessment2,111
8212663/2018NEUTAS INJECTIONFILGRASTIM APPLIED FOR GMP FULL ASSESSMENT 2018-09-06Queried_Assessment-Round12,084
8313531/2018FEBUDAY 40FEBUXOSTAT GMP CERTIFICATE AVAILABLE RECOGNITION 2018-09-24Peer Review2,066
8413531/2018FEBUDAY 80FEBUXOSTAT GMP CERTIFICATE AVAILABLE RECOGNITION 2018-09-24Peer Review2,066
8513957/2018FEVAROL PARACETAMOL, PHENYLEPHRINE,CHLORPHENIRAMINE MALEATE APPLIED FOR GMP ABRIDGED 2018-10-022nd Assessment Completed 2,058
8613958/2018RESPIMAXAMBROXOL HYDROCHLORIDE 15MG ,SALBUTAMOL SULFATE 1MG , GUAIFENESIN 50MG NOT APPLIED ABRIDGED 2018-10-02Peer Review2,058
8713972/2018BILAXTEN 20BILASTINE NOT APPLIED ABRIDGED 2018-10-02To Update Dossier2,058
8811070/2018DIARZILLOPERAMIDE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-10-08Not Assessed2,052
8914560/2018IVYTUSHEDERACOSIDE C NOT APPLIED ABRIDGED 2018-10-15Peer Review2,045
9014558/2018LEVANIX-500LEVOFLOXACIN HEMIHYDRATE NOT APPLIED ABRIDGED 2018-10-15Peer Review2,045
9114554/2018K-FLAMDICLOFENAC POTASSIUM NOT APPLIED ABRIDGED 2018-10-15Peer Review2,045
9214803/2018DUPHASTONDYDROGESTERONE NOT APPLIED ABRIDGED 2018-10-18Peer Review2,042
931479/2018DUSPATALINMEBEVERINE NOT APPLIED ABRIDGED 2018-10-18Peer Review2,042
9414795/2018ENTAMIZOLE 100MLDILOXAMIDE FUROATE & MENOTRONIDAZOLE NOT APPLIED ABRIDGED 2018-10-18Not Assessed2,042
9514794/2018BRUFEN-400IBUPROFEN APPLIED FOR GMP ABRIDGED 2018-10-18To Update Dossier2,042
9614801/2018BRUFEN SIROP PED. 100MLIBUPROFEN NOT APPLIED ABRIDGED 2018-10-18Peer Review2,042
9714797/2018DUPHALAC 15MLLACTULOSE NOT APPLIED ABRIDGED 2018-10-18To Update Dossier2,042
9814799/2018DUPHALAC 200MLLACTULOSE NOT APPLIED RECOGNITION 2018-10-18Peer Review2,042
9914804/2018ARTEMETHER + LUMEFANTRINARTEMETHER + LUMEFANTRIN GMP CERTIFICATE AVAILABLE ABRIDGED 2018-10-18Peer Review2,042
100049/2018CIRATROATROPINE SULPHATE INJECTION BP APPLIED FOR GMP ABRIDGED 2018-10-29Not Assessed2,031
101046-2018LIDOCAINELIDOCAINE HCL USP APPLIED FOR GMP ABRIDGED 2018-10-29Peer Review2,031
102051/2018DIGOXIN 0.25MG/MLDIGOXINE BP APPLIED FOR GMP ABRIDGED 2018-10-29Peer Review2,031
103047/2018KETRODOLPHYTOMENADIONE BP APPLIED FOR GMP ABRIDGED 2018-10-29Peer Review2,031
104044/2018METOCLOPRAMIDEMETOCLOPRAMIDE HYDROCHLORIDE BP APPLIED FOR GMP RECOGNITION 2018-10-29Peer Review2,031
105045/2018CIDOL INJECTION 5HALOPERIDOL BP APPLIED FOR GMP ABRIDGED 2018-10-29Peer Review2,031
106089/2018PENIREN 250PHENOXYMETHYLPENICILLIN POTASSIUM NOT APPLIED ABRIDGED 2018-11-02Peer Review2,027
107084/2018AMOXIKIDAMOXICILLIN TRIHYDRATE BP NOT APPLIED FULL ASSESSMENT 2018-11-022nd Assessment Completed 2,027
108088/2018FLUZOLEFLUCONAZOLE APPLIED FOR GMP ABRIDGED 2018-11-022nd Assessment Completed 2,027
109106/2018ARTENAMBETA-ARTEMETHER NOT APPLIED ABRIDGED 2018-11-06Peer Review2,023
110532/2018SODIUM CHLORIDE 0.9%SODIUM CHLORIDE APPLIED FOR GMP ABRIDGED 2018-11-12Peer Review2,017
111530/2018COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BPSODIUM LACTATE+POTASSIUM CHLORIDE+CALCIUM CHLORIDE+SODIUM CHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
112527/2018SODIUM CHLORIDE 0.9%+GLUCOSE 5%Sodium Chloride 0.9% W/V & glucose 5.0% W/V Intravenous APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
113528/2018TROZ METRONIDAZOLE IV INFUSION BP APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
114531/2018LEVO-LIFE LEVOFLOXACIN HEMIHYDRATE INTRAVENOUS APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
115526/2018CIP-LIFECIPROFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
116529/2018PARA-LIFEPARACETAMOL IV INFUSION BP APPLIED FOR GMP FULL ASSESSMENT 2018-11-12Not Assessed2,017
117154/2018RECTONAC-100DICLOFENAC SODIUM NOT APPLIED ABRIDGED 2018-11-13Peer Review2,016
118155/2018RECTOPAR-125MGACETAMINOPHEN USP NOT APPLIED FULL ASSESSMENT 2018-11-13Not Assessed2,016
119153/2018RECTOPAR-250MGACETAMINOPHEN USP NOT APPLIED FULL ASSESSMENT 2018-11-13Not Assessed2,016
120152/2018RECTOFLAM-100MELOXICAM APPLIED FOR GMP ABRIDGED 2018-11-13Pending 2st Assessment2,016
121242/2018ZIFAM SOVIR PLUS APPLIED FOR GMP FULL ASSESSMENT 2018-11-23Not Assessed2,006
122249/2018BUSCOMAX APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
123256/2018CYNOMAX 200 MCG 7X4 TAB APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
124250/2018ESMA-20ESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
125254/2018VALEPSY -200SODIUM VALPROATE APPLIED FOR GMP ABRIDGED 2018-11-26Not Assessed2,003
126255/2018VALEPSY -500 SODIUM VALPROATE APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
127252/2018ESMA-40ESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
128251/2018VALEPSY-300SODIUM VALPROATE APPLIED FOR GMP ABRIDGED 2018-11-26To Update Dossier2,003
129253/2018MAXPINE 20 MG NIFEDIPINE APPLIED FOR GMP FULL ASSESSMENT 2018-11-26Not Assessed2,003
130286/2018CLARYL-500CLARITHROMYCIN USP NOT APPLIED ABRIDGED 2018-11-28Peer Review2,001
131287/2018UMEPENEM-1000MEROPENEM USP NOT APPLIED FULL ASSESSMENT 2018-11-28To Update Dossier2,001
132310/2018DAZOLE 1X6SCLOTRIMAZOLE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-11-29To Update Dossier2,000
133300/2018INFI-AXONE 1 GRM IM/IV INJCEFTRIAXONE APPLIED FOR GMP ABRIDGED 2018-11-29To Update Dossier2,000
134299/2018INFICLAV 625AMOXICILLIN/CLAVULANIC ACID APPLIED FOR GMP ABRIDGED 2018-11-29To Update Dossier2,000
135307/2018 & 8582/2020NERVILIN 75MG CAPS 3X10PREGABALIN GMP CERTIFICATE AVAILABLE ABRIDGED 2018-11-29Peer Review2,000
136311/2018NORMNIL TAB 1TABALBENDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-11-29Not Assessed2,000
137302/2018INFCLAV 228 ORAL SUSP 100 MLAMOXICILLIN/CLAVULANIC ACID APPLIED FOR GMP ABRIDGED 2018-11-29To Update Dossier2,000
138555/2018NERVILIN NT CAPS 1X10PREGABALIN & NORTRIPTYLINE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-11-29Peer Review2,000
139309/2018LEVOCET TAB 5X10 SLEVOCETIRIZINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2018-11-29To Update Dossier2,000
140352/2018FINACE PLUSACECLOFENAC BP+PARACETAMOL BP APPLIED FOR GMP FULL ASSESSMENT 2018-11-30Pending GMP 1,999
141322/2018EZIUM-20MGESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 2018-11-302nd Assessment Completed 1,999
142323/2018EZIUM-40MGESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 2018-11-302nd Assessment Completed 1,999
143326/2018LEVOXIN 500MGLEVOFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2018-11-30Pending 1st Assessment1,999
144325/2018LEVOXIN 750MGLEVOFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2018-11-30Pending 1st Assessment1,999
145403/2018OXYTOCIN INJECTION BP 10IU/ML,OXYTOCIN BP NOT APPLIED ABRIDGED 2018-12-06To Update Dossier1,993
14614466/2018D-TAM TANSULOSINE & DUTASTERIDE APPLIED FOR GMP ABRIDGED 2018-12-10Peer Review1,989
14714466/2018DYNACORT 30MGDEFLAZACORT NOT APPLIED ABRIDGED 2018-12-10Peer Review1,989
14814466/2018DYNACORT SUSPENSIONDEFLAZACORT NOT APPLIED ABRIDGED 2018-12-10Peer Review1,989
149627/2018EFFERALGAN 500MG ,EFFERVESCENT SECABLEPARACETAMOL NOT APPLIED ABRIDGED 2018-12-20Under Approval1,979
150623/2018ASPIRINE VITAMIN C UPSA 330MGACETYLSALICYCLIC ACID 330MG +ASCORBIC ACID 200MG GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-20To Update Dossier1,979
151625/2018EFFERALGAN 500MG CAPSULESPARACETAMOL CAPSULES GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-20To Update Dossier1,979
152623/2018Aspirine UPSA Vitamin C 330MG/200MGACETYLSALICYCLIC ACID 330MG +ASCORBIC ACID 200MG GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-20To Update Dossier1,979
153621/2018EFFERALGAN 1G PARACETAMOL 1G GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-20Peer Review1,979
154622/2018EFFERALGAN 1G EFFPARACETAMOL EFFERVESCENT 1G GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-202nd Assessment Completed 1,979
155625/2018EFFERALGAN 500mg, Gelule, BPARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-12-20To Update Dossier1,979
156624/2018EFFERALGAN VITAMIN C 500MG/200MG PARACETAMOL 500MG VITAMIN C 200MG GMP CERTIFICATE AVAILABLE ABRIDGED 2018-12-20Peer Review1,979
157626/2018EFFERALGAN 500MG TABLETSPARACETAMOL PHARM EUR APPLIED FOR GMP ABRIDGED 2018-12-20Under Approval1,979
158628/2018EFFERALGAN VITAMIN C 330MG/200MGPARACETAMOL+ASCORBIC ACID APPLIED FOR GMP FULL ASSESSMENT 2018-12-20Not Assessed1,979
159603/2018HELIGO 500TINIDAZOLE+CLARITHROMYCIN+LANSOPRAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-12-20Peer Review1,979
160606/2018OZITAS-10OLANZAPINE GMP CERTIFICATE AVAILABLE RECOGNITION 2018-12-20Peer Review1,979
161608/2018OZITAS-5OLANZAPINE GMP CERTIFICATE AVAILABLE RECOGNITION 2018-12-20Peer Review1,979
162609/2018 RISDONE-2 RISPERIDONE NOT APPLIED FULL ASSESSMENT 2018-12-20Pending GMP 1,979
163604/2018NEBTAS-HNEBIVOLOL HYDROCHLORIDE+HYDROCHLORTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2018-12-20Peer Review1,979
16410333/2018ANDROGELTESTOSTERONE NOT APPLIED RECOGNITION 2018-12-21Peer Review1,978
165187/2019VERZOLALBENDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-01-23Peer Review1,945
166202/2019BLEOCIPBLEOMEMYCIN GMP CERTIFICATE AVAILABLE RECOGNITION 2019-01-24Under Approval1,944
167203/2019ESOMAC 20ESOMEPRASOLE MAGNESIUM DEHYDRATE NOT APPLIED RECOGNITION 2019-01-24Under Approval1,944
1680442/2019REZN DISPERSIBLE TABLETZINC SULPHATE MONOHYDRATE USP NOT APPLIED ABRIDGED 2019-01-31Peer Review1,937
1690327/2019AMATRIX-850METFORMIN APPLIED FOR GMP ABRIDGED 2019-02-042nd Assessment Completed 1,933
1700332/2019NEUROGIL-150PREGABALIN NOT APPLIED FULL ASSESSMENT 2019-02-04Pending GMP 1,933
1710333/2019CARDIOTEM 5AMLODIPINE BESYLATE 5MG APPLIED FOR GMP ABRIDGED 2019-02-04Peer Review1,933
1720334/2019FLUCANOLFLUCLOXACILLINE APPLIED FOR GMP FULL ASSESSMENT 2019-02-042nd Assessment Completed 1,933
173083/2018UMBI-GELCHLORHEXIDINE GLUCONATE BP APPLIED FOR GMP FULL ASSESSMENT 2019-02-11Not Assessed1,926
1740436/2019CLARITHROMYCIN 500CLARITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-02-14Not Assessed1,923
1750444/2019AMOXIRENAMOXICILLIN TRIHYDRATE NOT APPLIED ABRIDGED 2019-02-14Peer Review1,923
1760437/2019TERBINAFINE 250 TABLETSTERBINAFINE HYDROCHLORIDE NOT APPLIED FULL ASSESSMENT 2019-02-14Pending 1st Assessment1,923
1770435/2019CURAM 400/57AMOXICILLINE+POTASSIUM CLAVULANIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-02-142nd Assessment Completed 1,923
1780443/2019GLYCORENGLIBENCLAMIDE NOT APPLIED ABRIDGED 2019-02-14Peer Review1,923
1790447/2019ATRANGEL ULTRADICLOFENAC DIETYLAMINE +METHYL SALICYLATE+MENTHOL+CAPSICUM OLEORESIN APPLIED FOR GMP RECOGNITION 2019-02-14Peer Review1,923
1800574/2019LYSODOL 100ACECLOFENAC NOT APPLIED ABRIDGED 2019-02-20Peer Review1,917
1810576/2019LYSODOL 200SRACECLOFENAC NOT APPLIED ABRIDGED 2019-02-20Under Approval1,917
1820578/2019LYSODOL MRACECLOFENAC & PARACETAMOL & CHLORZOXAZONE NOT APPLIED ABRIDGED 2019-02-20Under Approval1,917
1830577/2019LYSODOL PACECLOFENAC & PARACETAMOL NOT APPLIED ABRIDGED 2019-02-20Under Approval1,917
1845422/2018FEMIGESTON-100PROGESTERONE BP NOT APPLIED FULL ASSESSMENT 2019-02-27Pending 1st Assessment1,910
1850654/2019VAGIMILTCLINDAMYCIN PHOSPHATE & CLOTRIMAZOLE APPLIED FOR GMP FULL ASSESSMENT 2019-02-27Pending 2st Assessment1,910
1865423/2018FEMIGESTON-300PROGESTERONE BP APPLIED FOR GMP FULL ASSESSMENT 2019-02-27Not Assessed1,910
1870679/2019JARDIANCE-10EMPAGLIFLOZINE NOT APPLIED ABRIDGED 2019-03-01Peer Review1,908
1880680/2019JARDIANCE-25EMPAGLIFLOZINE NOT APPLIED ABRIDGED 2019-03-01Peer Review1,908
189356/2018OFLOX -OZ OFLOXACIN+ORNIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-03-01To Update Dossier1,908
1900740/2019EFFERALGAN-300PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-03-07Peer Review1,902
1910735/2019EFFEREALGAN-150PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-03-07To Update Dossier1,902
1920744/2019NIFLUGEL 2.5NIFLUMIC ACID NOT APPLIED FULL ASSESSMENT 2019-03-07Pending GMP 1,902
1930738/2019EFFERALGAN-600PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-03-07Under Approval1,902
1940733/2019EFFERALGAN-80PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-03-07Under Approval1,902
1950739/2019EFFERALGAN CODEINE-500/30PARACETAMOL/CODEINE APPLIED FOR GMP FULL ASSESSMENT 2019-03-07Pending GMP 1,902
1960737/2019FERVEX FRAMBOISE-500/200/25PARACETAMOL/VIT C/ CHLOPHENIRAMINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-03-07To Update Dossier1,902
1970742/2019EFFERALGAN PEDIATRIC-3PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-03-07To Update Dossier1,902
1980765/2019THEOFIX -100 DSCEFIXIME NOT APPLIED FULL ASSESSMENT 2019-03-08Not Assessed1,901
1990766/2019THEOFIX -200CEFIXIME NOT APPLIED FULL ASSESSMENT 2019-03-08To Update Dossier1,901
2003960/2019BPHAMALGAN PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-03-12Pending 2st Assessment1,897
201355/2018CYPROL SYRUP 100 MLCYPROHEPTADINE HYDROCHLORIDE & LYSINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-03-12To Update Dossier1,897
2023960/2019APHAMALGAN FOR PERFUSIONPARACETAMOL APPLIED FOR GMP RECOGNITION 2019-03-12Under Approval1,897
203867/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 5MG/1000MG NOT APPLIED RECOGNITION 2019-03-15Under Approval1,894
204871/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 10MG/1000MG NOT APPLIED RECOGNITION 2019-03-15Under Approval1,894
205870/2019EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 25MG/1000MGEMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE 25MG/1000MG NOT APPLIED RECOGNITION 2019-03-15Under Approval1,894
206869/2019 FEMPROLETROZOLE NOT APPLIED RECOGNITION 2019-03-152nd Assessment Completed 1,894
2071010/2019BACTOCLAV DRY SYRUPAMOXICillin 100mg+Potassium |Clavuranate 12.5mg/ APPLIED FOR GMP ABRIDGED 2019-03-292nd Assessment Completed 1,880
2081027/2019ETROBAX 90ETORICOXID NOT APPLIED ABRIDGED 2019-04-01Under Approval1,877
2093110/2018ACUDOL 15 INJKETOTOLAC TROMETHAMANE NOT APPLIED RECOGNITION 2019-04-01Under Approval1,877
2103109/2018ACUDOL 30 INJKETOTOLAC TROMETHAMANE NOT APPLIED RECOGNITION 2019-04-01Under Approval1,877
2111034/2019CANDIMALE-15ORNIDAZOLE + MICONAZOLE NOT APPLIED ABRIDGED 2019-04-012nd Assessment Completed 1,877
2121020/2019OXYTOCIN 5IUOXYTOCIN NOT APPLIED RECOGNITION 2019-04-01Under Approval1,877
2131021/2019OXYTOCIN 10IUOXYTOCIN NOT APPLIED RECOGNITION 2019-04-01Under Approval1,877
2141024/2019CANDIVOR INJVORICONAZOLE NOT APPLIED RECOGNITION 2019-04-01Under Approval1,877
2151036/2019GASTROCID LIQUID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-012nd Assessment Completed 1,877
2161109/2019MICROGYNON EDLEVONORGESTREL/ETHINYLESTRADIOL APPLIED FOR GMP RECOGNITION 2019-04-08Under Approval1,870
2171159/2020VALPAGEN-300SODIUM VALPROATE NOT APPLIED ABRIDGED 2019-04-10To Update Dossier1,868
2181159/2021VALPAGEN-500SODIUM VALPROATE NOT APPLIED ABRIDGED 2019-04-10To Update Dossier1,868
2191159/2019VALPAGEN-200SODIUM VALPROATE NOT APPLIED ABRIDGED 2019-04-10Peer Review1,868
2201165/2019GACET-500PARACETAMOL EFFERVESCENT 500MG NOT APPLIED RECOGNITION 2019-04-11To Update Dossier1,867
2211168/2019 FINMOL PLUSPARACETAMOL, IBUPROFEN, CAFFEINE APPLIED FOR GMP FULL ASSESSMENT 2019-04-11Pending GMP 1,867
2221166/2019AGYCIN SUSPENSIONAZYTHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-11Peer Review1,867
2231167/2019 LOFNAC-P DICLOFENAC SODIUM, PARACETAMOL500MG GMP CERTIFICATE AVAILABLE RECOGNITION 2019-04-11Pending 1st Assessment1,867
2241169/2019GVFLUC SUSPENSIONFLUCONAZOLE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-11Pending 2st Assessment1,867
2254786/2019PENTA LIQUID VACCINE DEPHTHERIA, PERTUSSI, GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-12Not Assessed1,866
2261193/2019VERZOL ALBENDAZOLE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-04-15Not Assessed1,863
2271191/2019FLEXDOL ® TABLETSIBUPROFEN, METHOCARBAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-04-15Under Approval1,863
2281206/2019VITAFORTE SYRUPIRON PLUS VITAMINS NOT APPLIED FULL ASSESSMENT 2019-04-15Not Assessed1,863
2291213/2019NIFLURIL-700MORNIFLUMATE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-04-15To Update Dossier1,863
2301262/2019CARDIOZIDE ® HCTLOSARTAN AND HYDROCHLOROTHIAZIDE APPLIED FOR GMP ABRIDGED 2019-04-23Not Assessed1,855
2311270/2020STATINIMIPENEM& CILASTATIN FOR INJECTION USP 1000MG APPLIED FOR GMP FULL ASSESSMENT 2019-04-23Pending GMP 1,855
2321263/2019BEROXY ® SUSPENSIONAMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2019-04-23Pending GMP 1,855
2331269/2019 PIRONEM INJECTIONMEROPENEM NOT APPLIED ABRIDGED 2019-04-23Under Approval1,855
2341286/2019C-TAX T 200CEFIXIME APPLIED FOR GMP RECOGNITION 2019-04-25Pending 2st Assessment1,853
2351288/2019C-TAX P DRY SYRUP CEFIXIME APPLIED FOR GMP RECOGNITION 2019-04-25Under Approval1,853
2361287/2019AUGPEN 625 AMOXICILLINE+POTASSIUM CLAVULANATE APPLIED FOR GMP ABRIDGED 2019-04-25To Update Dossier1,853
2371285/2019CIPROBIOTIC CIPROFLOXACINE APPLIED FOR GMP RECOGNITION 2019-04-25To Update Dossier1,853
2381355/2019VASTAREL MRDICHLORHYDRATE DE TRIMETAZIDINE APPLIED FOR GMP FULL ASSESSMENT 2019-04-30Pending GMP 1,848
2391418/2019AMLOZAAR-H AMLODIPINE 5MG/LOSARTAN POTASSIUM 50MG/HYDROCHLOROTHIAZIDE 12.5MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-05-07Under Approval1,841
2401467/2019RHINAHIST PLUS SYRUP 100MLPROMETHAZINE HCL& CARBOCISTEINE NOT APPLIED FULL ASSESSMENT 2019-05-10Pending 2st Assessment1,838
2411495/2019MEFTAL-FORTE MEFENAMIC ACID BP AND PARACEUTAMOL APPLIED FOR GMP RECOGNITION 2019-05-14To Update Dossier1,834
2421493/2019MEFTAL-500 MEFENAMIC ACID BP APPLIED FOR GMP RECOGNITION 2019-05-14Under Approval1,834
2431511/2019MARA MOJA TABLETS.ASPIRIN, PARACETAMOL, CAFFEINE ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-05-152nd Assessment Completed 1,833
2441530/2019GYNASTATIN NYSTATIN BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-05-17Under Approval1,831
2451529/2019CLAMOXIN 625 TABLETS AMOXICILLIN 500MG, CLAVULANIC ACID 120MG TABLETS USP APPLIED FOR GMP FULL ASSESSMENT 2019-05-17Not Assessed1,831
2461546/2019KETOSTERIL APPLIED FOR GMP FULL ASSESSMENT 2019-05-20To Update Dossier1,828
2471547/2019ADDAVEN FERRIC CHLORIDE/ ZINC CHLORIDE/ MANGANESE CHLORIDE TETRAHYDRATE/ COPPER CHLORIDE DIHYDRATE/ SODIUM SELENITE ANHYDROUS/ POTASSIUM IODIDE/ CHROMIC CHLORIDE HEXAHYDRATE/ SODIUM FLUORIDE/ SODIUM MONHYDRATE DEHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2019-05-20Pending 2st Assessment1,828
2481549/2019SMOFKABIVEN GLUCOSE 42%/AA/ LIPID EMULSION 20% APPLIED FOR GMP RECOGNITION 2019-05-20Peer Review1,828
2491550/2019SMOFKABIVEN PERIPHERAL APPLIED FOR GMP RECOGNITION 2019-05-20Peer Review1,828
2501548/2019PARACETAMOL FRESENIUS PARACETAMOL FRESENIUS APPLIED FOR GMP RECOGNITION 2019-05-20Under Approval1,828
2511633/2019MM COMBI KITMISOPROSTOL & MISFEPRISTONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-05-23Peer Review1,825
2521638/2019CLOFAINS PARACEUTAMOL/ SODIUM DILOFENAC GMP CERTIFICATE AVAILABLE ABRIDGED 2019-05-242nd Assessment Completed 1,824
2531636/2019FERCEFOL SYRUPIRON (II) HYDROXIDE POLYMALTOSE/FOLIC ACID/ASCORBIC ACID GMP CERTIFICATE AVAILABLE ABRIDGED 2019-05-24To Update Dossier1,824
25417803/2017MELMET-500METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-05-29Not Assessed1,819
2551802/2019ACEM-500CLARITHROMYCIN APPLIED FOR GMP ABRIDGED 2019-05-30Under Approval1,818
2561992/2019DESLORASTAL DESLORATADINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05Under Approval1,812
2571996/2019DIPARA DICLOFENAC + PARACEUTAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05Under Approval1,812
2581401/2019ACTILOR SYRUPDESLORATADINE SYRUP NOT APPLIED RECOGNITION 2019-06-05Under Approval1,812
2591997/2019ESOPRAZOLE - 40MG ESOMEPRAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05Under Approval1,812
2601994/2019AZAL- 500MGAZITHROMYCINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-06-05Under Approval1,812
2612000/2019ARTESUNATE & AMODIAQUINE TAB ARTESUNATE & AMODIAQUINE GMP CERTIFICATE AVAILABLE ABRIGDED 2019-06-05Under Approval1,812
2621998/2019ARTESUNATE & AMODIAQUINE ARTESUNATE & AMODIAQUINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-06-05Peer Review1,812
2631999/2019ARTESUNATE & AMODIAQUINE TAB ARTESUNATE & AMODIAQUINE TAB (25/67.5MG) GMP CERTIFICATE AVAILABLE RECOGNITION 2019-06-05Under Approval1,812
2642003/2019PANTINPANTOPRAZOLE SODIUM NOT APPLIED FULL ASSESSMENT 2019-06-05Pending 2st Assessment, ADD.DATA1,812
2652032/2019BG COLDPARACETAMOL 500MG,CAFFEINE BP 30MG,PHENYLEPHRINE HCL BP 5MG,CHLORPHENIRAMINE MALEATE BP 2MG APPLIED FOR GMP FULL ASSESSMENT 2019-06-06Pending GMP 1,811
2662031/2019AMIFER FORTEIRON HYDROXIDE AND FOLIC ACID APPLIED FOR GMP FULL ASSESSMENT 2019-06-06Pending 1st Assessment1,811
2672029/2019AMIFER IV, INFUSION SOLUTIONIRON SUCROSE APPLIED FOR GMP FULL ASSESSMENT 2019-06-06Pending 1st Assessment1,811
2681829/2018RESIFURAN SIMETHICONE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-06-19To Update Dossier1,798
2692240/2019TRIMETABOL METOPINE,L-LYSINE HCL,DL-CARNITINE,THIAMINE HCL,PYRIDOXINE,CYANOCOBALAMIN APPLIED FOR GMP FULL ASSESSMENT 2019-06-192nd Assessment Completed 1,798
2701837/2018SOMAZINA -500CITICOLINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-06-19To Update Dossier1,798
271488/2018POTENCIATOR ARGININE ASPARTATE NOT APPLIED FULL ASSESSMENT 2019-06-19Pending 2st Assessment1,798
2722239/2019CROSSCAL TABLETCALCIUM&VITAMIN D3 APPLIED FOR GMP FULL ASSESSMENT 2019-06-19Not Assessed1,798
2732237/2019CROSSCAL CALCIUM&VITAMIN D3 APPLIED FOR GMP FULL ASSESSMENT 2019-06-19Pending 1st Assessment1,798
2741834/2018SOMAZINA-100 SUSPCITICOLINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-06-19Peer Review1,798
2752238/2019ADIONE DOXYLAMINE SUCCINATE&PYRIDOXINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-06-192nd Assessment Completed 1,798
2762246/2019POSITON POMMADE TRIAMCINOLONE 1MG/G,NEOMYCINE 2.5MG/G,NYSTATIN 100000 I.U/G NOT APPLIED ABRIDGED 2019-06-19Peer Review1,798
27718080/2017ALER ZCETIRIZINE DIHYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2019-07-03Pending 1st Assessment1,784
2782411/2019BUDECOT 0.5MG BUDESONIDEINHALATION SUSPENTION 0.5MG/2ML GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-03Under Approval1,784
2792410/2019ERLOCIP 100ERLOTINIB TABLETS 100MG NOT APPLIED ABRIDGED 2019-07-03Peer Review1,784
2802409/2019ERLOCIP 150ERLOTINIB TABLETS 150MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-03Peer Review1,784
2812412/2019ERLOCIP 25 ERLOTINIB TABLETS 25MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-03Under Approval1,784
2825931/2017INSTGRA TABLETSDOLUTGRAVIR 50MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-08To Update Dossier1,779
2832442/2019VONAVIR TABLETS EFAVIRENZ&EMTRICITABINE&TENOFOVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-07-08Peer Review1,779
2843666/2019A-CERUMEN EAR HYGIENE SOLUTION IN UNIDOSE SOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION NOT APPLIED FULL ASSESSMENT 2019-07-10Not Assessed1,777
2853667/2019A-CERUMEN EAR HYGIENE SOLUTION INSPRAYSOLUTION OF SODIUM ACYL SARCOSINATE SUCROSE LAURATE SOLUTION APPLIED FOR GMP FULL ASSESSMENT 2019-07-10Not Assessed1,777
2862565/2019ARTIM ARTEMETHER INJECTION 80MG/ML() 1ML INJECTION GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-16Under Approval1,771
2872568/2019 KALFEN DICLOFENAC SODIUM INJECTION GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-07-16Pending 2st Assessment, ADD.DATA1,771
2882570/2019TWYNSTA, 80 MG TELMISARTAN&AMLODIPINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-162nd Assessment Completed 1,771
2892579/2019LAMADOL TRAMADOL HCI APPLIED FOR GMP FULL ASSESSMENT 2019-07-16Pending 1st Assessment1,771
2902567/2019 CIS-CURON INJECTION CIS-ATRACURIUM BESYLATE INJECTION USP APPLIED FOR GMP ABRIDGED 2019-07-162nd Assessment Completed 1,771
2912558/2019 OVACARE L-ARGININE&FOLIC ACID&VIT B 12&B6&SELENIUM NOT APPLIED FULL ASSESSMENT 2019-07-16Pending GMP 1,771
2922602/2019IXINE 200 CEFIXIME TRIHYDRATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-07-182nd Assessment Completed 1,769
2932600/2019FLUOXINE 750CIPROFLOXACIN HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-07-182nd Assessment Completed 1,769
2942634/2019&9090/2022PAEDIATRIC COTRIMOXAZOLE SULPHAMETHOXAZOLE&TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-07-22Not Assessed1,765
2952668/2019NADICLOX 2% OINTMENTFUSIDIC ACID GMP CERTIFICATE AVAILABLE RECOGNITION 2019-07-23Peer Review1,764
29617802/2017TORSINEX-20 TABLETSTORSEMIDE 20 MG TABLETS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-24Under Approval1,763
2972729/2019DEXA-N NEOMYCIN SULFATE&DEXAMETHASONE SODIUM&PHOSPHATE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-07-26Not Assessed1,761
2982813/2019& 2814/2019PERFALGAN 10MG/ML SOLUTION FOR PERFUSION 100ML& 50MLPARACETAMOL APPLIED FOR GMP ABRIDGED 2019-08-01Under Approval1,755
2990767/2019THEOCLAV-625AMOXICILLIN AND POTASSIUM CLAVULANATE APPLIED FOR GMP FULL ASSESSMENT 2019-08-03Not Assessed1,753
3000770/2019THEOFIX-400CEFIXIME APPLIED FOR GMP FULL ASSESSMENT 2019-08-03Pending 1st Assessment1,753
3010772/2019THEOMYCIN-250ERYTHROMYCIN USP APPLIED FOR GMP FULL ASSESSMENT 2019-08-03Pending 1st Assessment1,753
3028815/2017& 0769/2019THEOPRIM-960SULFAMETHOXAZOLE+TRIMETHOPRIM APPLIED FOR GMP FULL ASSESSMENT 2019-08-03Pending 1st Assessment1,753
3030771/2019THEOMOX-500AMOXICILLIN CAPSULES USP 500MG APPLIED FOR GMP FULL ASSESSMENT 2019-08-03Pending 1st Assessment1,753
3041118/2019HUCOC-5000 HPCHORIONIC GONADOTROPHIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-04To Update Dossier1,752
3051122/2019ASPORELIX INJECTIONCETRORELIX ACETATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-042nd Assessment Completed 1,752
3061123/2019AMPHOTRET INJECTIONAMPHOTERICIN B INJECTION GMP CERTIFICATE AVAILABLE ABRIDGED 2019-08-04To Update Dossier1,752
3072846/2019EMITINO INJECTIONONDANSETRON INJECTION USP 2MG/ML APPLIED FOR GMP FULL ASSESSMENT 2019-08-06Pending 1st Assessment1,750
3082877/2019POSITON CREAMTRIMCINOLONE ACETONIDE, NEOMYCIN SULPHATE, NYSTATIN NOT APPLIED ABRIDGED 2019-08-07Under Approval1,749
3092843/2019CACHINERVE CAPSULEALPHA LIPOIC ACID,GAMMA LINOLENIC ACID,PYRIDOXINE HYDROCHLORIDE,METHYL COBALAMIN AND CHROMIUM CAPSULES GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-07Not Assessed1,749
3102876/2019BILAXTEN SIROP BOTTLE OF 150 MLBILASTINE 2.5MG/ML NOT APPLIED FULL ASSESSMENT 2019-08-07Pending GMP 1,749
3112443/2019ATAZOR-R-300/100ATANAVIR SULPHATE/RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-07Under Approval1,749
3122893/2019DADOMYCIN NOT APPLIED FULL ASSESSMENT 2019-08-09To Update Dossier1,747
3132905/2019LABGENTIL TABLETSSECNIDAZOLE 500MG TABLETS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-08-13Under Approval1,743
3142984/2019NEWCOX - TH ETORICOXIB&THIOCOLCHICOSIDE NOT APPLIED ABRIDGED 2019-08-20Under Approval1,736
3152982/2019NEWCOX - 120 ETORIXOCIB NOT APPLIED ABRIDGED 2019-08-20Peer Review1,736
3162979/2019MONTIKAST -LAMONTELUKAST SODIUM & LEVOCETIRIZINE HYDROCHLORIDE TABLETS NOT APPLIED ABRIDGED 2019-08-20Peer Review1,736
3172976/2019PHARMADOL - 10 PARACETAMOL CAPLETS 500MG NOT APPLIED ABRIDGED 2019-08-20Under Approval1,736
3182983/2019SPASMODEX - P PARACETAMOL&HYOSCINE BUTYLBROMIDE TABLETS NOT APPLIED ABRIDGED 2019-08-20Peer Review1,736
3192985/2019NEWCOX - P ETORIXOCIB&PARACETAMOL APPLIED FOR GMP ABRIDGED 2019-08-20To Update Dossier1,736
3203358/2018WOSULIN N-100ISOPHANE INSULINE N APPLIED FOR GMP ABRIDGED 2019-08-21Under Approval1,735
3213065/2019MONTIKAST 10 MONTELUKAST 10MG NOT APPLIED ABRIDGED 2019-08-23Under Approval1,733
3223146/2019NEUTRAFLUX SUSPENSIONALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE SUSPENSION APPLIED FOR GMP FULL ASSESSMENT 2019-08-272nd Assessment Completed 1,729
3233147/2019NEUTRAFLUX TABLETSALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE TABLETS APPLIED FOR GMP FULL ASSESSMENT 2019-08-272nd Assessment Completed 1,729
3243143/2019CONTUS PAEDIATRIC LINCTUSCHLORPHENAMINE,PHENYLEPHINE&DEXTROMETHORPHAN LINCTUS APPLIED FOR GMP FULL ASSESSMENT 2019-08-272nd Assessment Completed 1,729
3253142/2019CONTUS PLUS PAEDIATRIC SUSPENSION)CHLORPHENAMINE,PHENYLEPHINE&PARACETAMOL SUSPENSION APPLIED FOR GMP FULL ASSESSMENT 2019-08-27Pending 1st Assessment1,729
3263144/2019CONTUS-650 TABLETCHLORPHERAMINE,PHENYLEPHINE&PARACETAMOL TABLET APPLIED FOR GMP FULL ASSESSMENT 2019-08-27Pending 1st Assessment1,729
3273145/2019DREZ POWDERIODATED-PROVIDONE&METRONIZADOLE POWDER APPLIED FOR GMP FULL ASSESSMENT 2019-08-27Queried_Assessment-Round11,729
3283141/2019DREZ GARGLEIODINATED-PROVIDONE GARGLE APPLIED FOR GMP FULL ASSESSMENT 2019-08-27Pending 1st Assessment1,729
3293148/2019DREZ-V GELMICONAZOLE NITRATE&METRONIDAZOLE GEL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-08-27Under Approval1,729
3303139/2019DREZ SOLUTIONIODATED-PROVIDONE&METRONIZADOLE SOLUTION APPLIED FOR GMP FULL ASSESSMENT 2019-08-282nd Assessment Completed 1,728
3313140/2019DREZ OINTMENTIODINATED-PROVIDONE&METRONIDAZOLE OINTMENT APPLIED FOR GMP FULL ASSESSMENT 2019-08-292nd Assessment Completed 1,727
3323190/2019EFAVIRENZ 400MG/LAMIVUDINE 300MG/TENOFOVIR 300MG)EFAVIRENZ 400MG/LAMIVUDINE 300MG/TENOFOVIR 300MG) GMP CERTIFICATE AVAILABLE ABRIDGED 2019-08-30Under Approval1,726
3333273/2019FRESENIUS PROPOVEN 1%PROPOFOL APPLIED FOR GMP ABRIDGED 2019-09-06Under Approval1,719
3343271/2019KABIVEN (FAT EMULSION+GLIUCOSE SOLUTION+ AMINO ACID SOLUTION)KABIVEN APPLIED FOR GMP ABRIDGED 2019-09-06Not Assessed1,719
3353333/2019ZENSALBU NEBULE 2.5 SALBUTAMOL 2.5MG/2.5ML NOT APPLIED ABRIDGED 2019-09-11Under Approval1,714
3363350/2019EMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE + TENOFOVIR DISOPROXIL FUMARATE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-09-12Under Approval1,713
3373457/2019NUBIN-20NALBUPHINE APPLIED FOR GMP FULL ASSESSMENT 2019-09-20Pending GMP 1,705
3383458/2019NUBIN-10NALBUPHINE APPLIED FOR GMP FULL ASSESSMENT 2019-09-20Pending GMP 1,705
3393459/2019XAROBANRIVAROXABAN APPLIED FOR GMP ABRIDGED 2019-09-20Under Approval1,705
3403476/2019PYLOOCAIN OINTMENT (ANTI HAEMORRHOIDAL OINTMENT), 30G ANTI HEMORRHOIDAL OINTMENT NOT APPLIED ABRIDGED 2019-09-23Under Approval1,702
3413490/2019KODOXY DOXYCYCLINE BP APPLIED FOR GMP ABRIDGED 2019-09-23Under Approval1,702
3423487/2019LOKIT (OMEPRAZOLECAPSULES 20MG)OMEPRAZOLE APPLIED FOR GMP RECOGNITION 2019-09-23To Update Dossier1,702
3433491/2019AMYN-500AMOXICILLIN CAPSULES APPLIED FOR GMP FULL ASSESSMENT 2019-09-23Not Assessed1,702
3443493/2019MEFTAL FORTE CREAM METHYL SALICYLATE 30% W/W, MENTHOL USP 10%W/W, CAMPHOR USP 5% W/W, CREAM BASE Q.S APPLIED FOR GMP ABRIDGED 2019-09-23To Update Dossier1,702
3453531/2019 PALONOSETRON HYDROCHLORIDE INJECTION 0.25MG/ML, 5ML VIALPALONOSETRON HYDROCHLORIDE NOT APPLIED RECOGNITION 2019-09-25Pending 2st Assessment1,700
3463532/2019GEFITINIB GEFITINIB Ph.Eur. NOT APPLIED ABRIDGED 2019-09-25To Update Dossier1,700
3473560/2019LARINATEArtesunate GMP CERTIFICATE AVAILABLE RECOGNITION 2019-09-27Under Approval1,698
3483560/2019LUMERAX-DTARTEMETHER & LUMEFANTRINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-09-28Under Approval1,697
3493668/2019MARIMER ISOTONIC BABY NASAL SPRAYISOTONIC SEA WATER SOLUTION NOT APPLIED FULL ASSESSMENT 2019-10-07Pending 1st Assessment1,688
3503670/2019PHYSIODOSE 0,9% SODIUM CHLORIDE NOT APPLIED ABRIDGED 2019-10-07Pending 1st Assessment1,688
3513669/2019MARIMER HYPERTONIC BABY NASAL SPRAYHYPERTONIC SEA WATER SOLUTION NOT APPLIED FULL ASSESSMENT 2019-10-07Pending 1st Assessment1,688
3523773/2019SALBUCORT INHALERSALBUTAMOL NOT APPLIED ABRIDGED 2019-10-14Under Approval1,681
3533834/2019ABACAVIR,DOLUTEGRAVIR,LAMUVIDINEABACAVIR,DOLUTEGRAVIR,LAMUVIDINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-10-18Under Approval1,677
3543840/2019BECLOMIN 250 HFA INHALERBECLOMETHASONE NOT APPLIED ABRIDGED 2019-10-18Peer Review1,677
3553863/2019PRELYNCA-50PREGABALIN NOT APPLIED RECOGNITION 2019-10-21Under Approval1,674
3563862/2019PRELYNCA-75PREGABALIN NOT APPLIED RECOGNITION 2019-10-21Under Approval1,674
3573864/2019PRELYNCA-150PREGABALIN NOT APPLIED FULL ASSESSMENT 2019-10-21Pending 1st Assessment1,674
3583870/2019CARTIL FORTE GLUCOSAMINE + CHONDROITIN NOT APPLIED ABRIDGED 2019-10-21Peer Review1,674
3593867/2019CARTIL SUPER FORTE PLUSGLUCOSAMINE PLUS MSM + DIACEREIN NOT APPLIED ABRIDGED 2019-10-212nd Assessment Completed 1,674
3603868/2019GLIPMEVIA 50/1000 SITAGLIPTIN + METFORMIN HCL APPLIED FOR GMP ABRIDGED 2019-10-21Under Approval1,674
3613871/2019GLIPMEVIA 50/500 SITAGLIPTIN + METFORMIN HCL APPLIED FOR GMP ABRIDGED 2019-10-21Under Approval1,674
3623869/2019GLIPMEVIA 50/850SITAGLIPTIN + METFORMIN HCL NOT APPLIED ABRIDGED 2019-10-21Under Approval1,674
3633885/2019CO-MICARDIS 40/12.5TELMISARTANT 40MG+HYDROCHLOROTHIAZIDE 12.5MG NOT APPLIED ABRIDGED 2019-10-21Under Approval1,674
3643884/2019CO-MICARDIS 80/12.5TELMISARTANT 80MG+HYDROCHLOROTHIAZIDE 12.5MG NOT APPLIED ABRIDGED 2019-10-21Under Approval1,674
3653888/2019MICROLUT LEVONORGESTREL APPLIED FOR GMP RECOGNITION 2019-10-21Under Approval1,674
3663909/2019MICROMOX EYE DROPMOXIFLOXACIN AS HYDROCHLORIDE APPLIED FOR GMP ABRIDGED 2019-10-22Under Approval1,673
3673923/2019 BRIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG (10X10 TAB, 2BOXES AND 18X5 2 BOXES)RIFAMPIN AND ISONIAZID DISPERSIBLE TABLETS 75/50MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-10-22To Update Dossier1,673
3683907/2019GRAMOCEF-O-50 DRY SYRUPCEFIXIME 50MG/5ML NOT APPLIED ABRIDGED 2019-10-22Peer Review1,673
3693923/2019 ADOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE TABLET 50MG,300MG & 300MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-10-22Under Approval1,673
3703958/2019 DAPTOMYCINE DAPTOMYCIN NOT APPLIED FULL ASSESSMENT 2019-10-23Pending GMP 1,672
3713930/2019MICROVISC 1%AND DECORIAMICROVISC 1%AND DECORIA NOT APPLIED FULL ASSESSMENT 2019-10-23Not Assessed1,672
3723929/2019MICROVISC 1.4% AND DECORIAMICROVISC 1.4% AND DECORIA NOT APPLIED FULL ASSESSMENT 2019-10-23Not Assessed1,672
3733931/2019MICROVISC 2.5% AND DECORIAMICROVISC 2.5% AND DECORIA NOT APPLIED FULL ASSESSMENT 2019-10-23Not Assessed1,672
3743938/2019EFFERALGAN 1000MG, FRUITS ROUGES, EFFERVESCENT TABLETS, BOX OF 8 TABLETSPARACETAMOL APPLIED FOR GMP ABRIDGED 2019-10-23Under Approval1,672
3753944/2019HELMINTOX 125MG, SCORED FILM-COATED TABLETSPYRANTEL EMBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-10-232nd Assessment Completed 1,672
3763945/2019HELMINTOX 125MG/2.5ML ORAL SUSPENSION (BOX OF 25 SACHETS)PYRANTEL EMBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-10-232nd Assessment Completed 1,672
3773988/2019CLOPIDOGREL CLOPIDOGREL HYDROGEN SULPHATE NOT APPLIED FULL ASSESSMENT 2019-10-24Pending GMP 1,671
3784022/2019MICARDIS-40TERMISARTAN NOT APPLIED ABRIDGED 2019-10-29Under Approval1,666
3794021/2019MICARDIS-80TERMISARTAN NOT APPLIED ABRIDGED 2019-10-29Under Approval1,666
3804069/2019PIRITON 4MGCHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-11-01Peer Review1,663
3814073/2019PIRITON SYRUPCHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-11-01Peer Review1,663
3824071/2019PIRITON CHLORPHENIRAMINE MALEATE + AMMONIUM CHLORIDE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-01Under Approval1,663
3834072/2019CALPOL SUSPENSIONPARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-01Under Approval1,663
3844070/2019PANADOL ADVANCE PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-01Under Approval1,663
3854124/2019EROCIN-250EURTHROMYCIN STREATE BP GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-06Under Approval1,658
3864310/2019VAPTOR-5ROSUVASTATIN APPLIED FOR GMP FULL ASSESSMENT 2019-11-15Pending 1st Assessment1,649
3874311/2019VAPTOR-10ROSUVASTATIN APPLIED FOR GMP FULL ASSESSMENT 2019-11-15Pending 1st Assessment1,649
3884309/2019VAPTORROSUVASTATIN APPLIED FOR GMP ABRIDGED 2019-11-152nd Assessment Completed 1,649
3894392/2019ACEFENACECLOFENEC NOT APPLIED FULL ASSESSMENT 2019-11-19Pending GMP 1,645
3904396/2019KOFLYN PINEAPPLE FLAVOUR COUGH EXPECTORANT CHLORAMPHENIRAMINE MALEATE, AMMONIUM CHLORIDE, SODIUM CITRATE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-19Under Approval1,645
3914390/2019COLDRIL SUSPENSIONPARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-19To Update Dossier1,645
3924416/2019GACET -250ACETAMINOPHEN UPS APPLIED FOR GMP RECOGNITION 2019-11-20Under Approval1,644
3934418/2019GACET -125 ACETAMINOPHEN UPS APPLIED FOR GMP RECOGNITION 2019-11-20Under Approval1,644
3944428/2019FUNBACT-A CREAM CLOTRIMAZOLE, BETAMETHASONE, DIPROPIONATE NOT APPLIED RECOGNITION 2019-11-20Under Approval1,644
3954423/2019ANOMEX HYDROCOTISONE ACATATE, LIDOCAINE , ZINC OXIDE & ALLANTOIN SUPPOSITORY GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-20Under Approval1,644
3964427/2019KLOVINAL METRONIDAZOLE, CLOTRIMAZOLE, LACTO BACILLUS GMP CERTIFICATE AVAILABLE ABRIDGED 2019-11-20Under Approval1,644
3974420/2019LOFNAC GELLINSEED OIDICLOFENAC DIETHYLAMINE, METHYL SALICYLATE AND METHOL GEL APPLIED FOR GMP ABRIDGED 2019-11-20Pending GMP 1,644
3983360/2019DIGOXINDIGITALIS APPLIED FOR GMP ABRIDGED 2019-11-21Under Approval1,643
3994100/2019INTELENCE-100INTRAVIRINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-22Under Approval1,642
4004100/2019INTELENCE-25INTRAVIRINE GMP CERTIFICATE AVAILABLE RECOGNITION 2019-11-22To Update Dossier1,642
4014761/2019COTRIZIM 480 MGSULFAMETHOXAZOLE 400MG/TRIMETHOPRIM 80MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03Under Approval1,631
4024764/2019COLCIBID-200CELECOXIB GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03Under Approval1,631
4034768/2019ZIMAGRA -50SILDENAFIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-12-03Not Assessed1,631
4044766/2019CEFAZIM-200MGCEFIXIME GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03Under Approval1,631
4054755/2019ESOZIM-40ESOMEPRAZOLE MAGNESIUM DR CAPSULES USP 40MG GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-03Under Approval1,631
4064782/2019DIPHTHERIA AND TETANUS VACCIN DIPHTHERIA TOXOID, TETANUS TOXOID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-12-04Not Assessed1,630
4074781/2019MEASLES AND RUBELLA VACCIN MEASLES VIRUS AND RUBELLA VIRUS GMP CERTIFICATE AVAILABLE RECOGNITION 2019-12-04To Update Dossier1,630
4084856/2019 SODIUM LACTATE SODIUM LACTATE APPLIED FOR GMP ABRIDGED 2019-12-05To Update Dossier1,629
4094860/2019 EMTRICITABINE AND TENOFOVIR ALAFENAMIDE EMTRICITABINE AND TENOFOVIR ALAFENAMIDE NOT APPLIED FULL ASSESSMENT 2019-12-05Pending GMP 1,629
4104851/2019D5 GLUCOSE APPLIED FOR GMP ABRIDGED 2019-12-05Under Approval1,629
4114854/2019CIPROFLOXACIN 0.2%CIPROFLOXACIN APPLIED FOR GMP ABRIDGED 2019-12-05Under Approval1,629
4124861/2019NIRMET METRONIDAZOLE APPLIED FOR GMP RECOGNITION 2019-12-05Under Approval1,629
4134850/2019D5 500ML GLUCOSE APPLIED FOR GMP ABRIDGED 2019-12-05To Update Dossier1,629
4144859/2019NS-500ML SODIUM CHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-12-05Not Assessed1,629
4154984/2019STOPKOF- PDIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE APPLIED FOR GMP ABRIDGED 2019-12-11Under Approval1,623
4164992/2019TETRACYCLINE HCLTETRACYCLINE NOT APPLIED FULL ASSESSMENT 2019-12-11Pending GMP 1,623
4174991/2019NIPINE-10NIFEDIPINE NOT APPLIED ABRIDGED 2019-12-11Under Approval1,623
4184993/2019NIPINE-20NIFEDIPINE NOT APPLIED ABRIDGED 2019-12-11Under Approval1,623
4195031/2019&377/2022APHRODIS-100SILDENAFIL CITRATE APPLIED FOR GMP FULL ASSESSMENT 2019-12-12Not Assessed1,622
4205035/2019GALCIPRO-500CIPROFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2019-12-12Pending GMP 1,622
4215033/2019CHOCOFER SYRUPIRON HYDROCLORIDE WITH POLYMALTOSE COMPLEX FOLIC ACID APPLIED FOR GMP FULL ASSESSMENT 2019-12-12Not Assessed1,622
4225032/2019PIPTAZONE 4.5PIPERACINE SODIUM UPS AND TAZOBACTAM SODIUM APPLIED FOR GMP FULL ASSESSMENT 2019-12-12Pending 2st Assessment1,622
4235034/2019APHRODIS-50SILDENAFIL CITRATE APPLIED FOR GMP FULL ASSESSMENT 2019-12-12Pending 1st Assessment1,622
4245298/2019MANNITOL IV 100ML (20% W/V)MANNITOL BP APPLIED FOR GMP FULL ASSESSMENT 2019-12-23Peer Review1,611
4255367/2019DACOLD CAPSULESPARACETAMOL BP + CAFFEINE ANHYDROUS BP+ PSEUDOEPHEDRINE HCL BP + CHLORPHENIRAMINE MALEATE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-272nd Assessment Completed 1,607
4265369/2019DAWACLOX-250 PACK 10x10CLOXACILLINE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27Under Approval1,607
4275373/2019MOXACIL DS-250 (100ML& 60ML)AMOXYCILLINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27Under Approval1,607
4285381/2019MOXACIL-125 (100ML&60ML)AMOXYCILLINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27Under Approval1,607
4295376/2019ERYTHROX-125 BOTTLE 100MLERYTHROMYCINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2019-12-27Not Assessed1,607
4305377/2019ERYTHROX-250 (10X10 & 1000)ERYTHROMYCINE GMP CERTIFICATE AVAILABLE ABRIDGED 2019-12-27Under Approval1,607
4310084/2020DARUNAVIR ETHANOLATE + RITONAVIRDARUNAVIR ETHANOLATE + RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-01-062nd Assessment Completed 1,597
4325480/2018KOCITAF Dolutegravir /emtricitabine /Tenofovir alafenamide Fumarate GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-01-06Not Assessed1,597
4331390/2020TRISPORIN SPCEFDINIR NOT APPLIED ABRIDGED 2020-02-12Under Approval1,560
4341881/2020PANADOL EXTRA WITH OPTIZORBPARACETAMOL+CAFFEINE NOT APPLIED ABRIDGED 2020-02-24Under Approval1,548
4353416/2019 TWINZOLDORZOLAMIDE/TIMOLOL GMP CERTIFICATE AVAILABLE ABRIDGED 2020-02-26Pending 1st Assessment1,546
4363412/2019 & 1997/2020ORCHAZID KETOTIFEN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-02-26Under Approval1,546
4371998/2020AUGMACILLIN ORAL SUSPENSION 229.6AMOXICILLIN TRIHYDRATE& POTASSIUM CLAVULANATE NOT APPLIED FULL ASSESSMENT 2020-02-26Not Assessed1,546
4382000/2020AUGMACILLIN ORAL SUSPENSION 400AMOXICILLIN TRIHYDRATE& POTASSIUM CLAVULANATE NOT APPLIED FULL ASSESSMENT 2020-02-26Not Assessed1,546
4399827/2017DICLOFENAC SODIUM INJECTIONDICLOFENAC SODIUM BP NOT APPLIED FULL ASSESSMENT 2020-02-26Not Assessed1,546
4402460/2020DICYNONE INJETAMYSLATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-03-09Not Assessed1,534
4414849/2020& 7583/2020AMARYL-M 2/500 IRGLIMEPIRIDE +METFORMIN NOT APPLIED ABRIDGED 2020-03-11Under Approval1,532
4422764/2020IPNODISMIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-03-13To Update Dossier1,530
4432761/2020QUADRIMUNEABACAVIR+ LAMIVUDINE+ LOPINAVIR+ RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-03-13Not Assessed1,530
444CANDID-2020CANDID DUSTING POWDERCLOTRIMAZOLE USP NOT APPLIED ABRIDGED 2020-03-27Under Approval1,516
445CURAM200-2020CURAM QUICKTAB 200/28.5AMOXICILLIN+ POTASSIUM CLAVULANIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-03-30Pending 1st Assessment1,513
446CURAM250-2020CURAM QUICKTAB 250/62.5MGAMOXICILLIN+ POTASSIUM CLAVULANIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-03-30Pending 1st Assessment1,513
447CURAM400-2020CURAM 400/57AMOXICILLIN+ POTASSIUM CLAVULANIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-03-30Pending 1st Assessment1,513
4483475/2018OPELAN ODT OLANZAPINE ORODISPERSIBLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-05-04Under Approval1,478
449BENYLINPED-2020BENYLIN PEDIATRICDIPHENHYDRAMINE HYDROCHLORIDE APPLIED FOR GMP ABRIDGED 2020-05-04Peer Review1,478
450BENYLINORIG-2020BENYLIN ORIGINALDIPHENHYDRAMINE HYDROCHLORIDE/ AMMONIUM CHLORIDE APPLIED FOR GMP ABRIDGED 2020-05-04Under Approval1,478
451BENYLINCOD-2020BENYLIN WITH CODEINEDIPHENHYDRAMINE HYDROCHLORIDE/ AMMONIUM CHLORIDE/ CODEINE PHOSPHATE APPLIED FOR GMP ABRIDGED 2020-05-04Under Approval1,478
452LUBREX-2020LUBREX EYE DROPSCARBOXYMETHYL CELLULOSE SODIUM APPLIED FOR GMP FULL ASSESSMENT 2020-05-28Queried_Assessment-Round11,454
453EROSTINSUSP-2020EROSTIN SUSPENSIONEBASTINE GMP CERTIFICATE AVAILABLE RECOGNITION 2020-05-28Under Approval1,454
454EROSTIN-2020EROSTIN TABLETSEBASTINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-05-28Under Approval1,454
455LEVOBACT-2020LEVOBACT EYE DROPS(Nadine)LEVOFLOXACIN HEMIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2020-05-28Pending GMP 1,454
456TACOMA-2020TACOMA EYE DROPSTIMOLOL APPLIED FOR GMP FULL ASSESSMENT 2020-05-28Not Assessed1,454
457AZITAR-2020AZITAR-250AZITHROMYCIN APPLIED FOR GMP RECOGNITION 2020-05-30To Update Dossier1,452
4584054/2020DOXYRONE-100DOXYCYCLINE NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4594055/2020SIMTRIM-480COTRIMOXAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4604057/2020CARBAMAZEPINE-200CARBAMAZEPINE NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4614058/2020SPIRONOLACTONE-25SPIRONOLACTONE NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4624056/2020GRISEOSIM-500GRISEOFLUVIN NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4634059/2020HYOSIMHYOSCINE BUTYLBROMIDE NOT APPLIED FULL ASSESSMENT 2020-06-03Pending GMP 1,448
4644629/2020SP-INFRA 100DICLOFENAC SODIUM SUPPOSITORIES APPLIED FOR GMP FULL ASSESSMENT 2020-06-24Not Assessed1,427
4654638/2020ESORAV-20ESOMEPRAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4664643/2020ESORAV-40ESOMEPRAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4674639-2020GABACENT-300GABAPENTIN NOT APPLIED FULL ASSESSMENT 2020-06-24Not Assessed1,427
4684646/2020ITRARAVITRACONAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending 1st Assessment1,427
4694625/2020OFHEAL OZOFLOXACIN + ORNIDAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4704645/2020ORAV-OZOFLOXACIN + ORNIDAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4714632/2020SP-PYRA 250PARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2020-06-24Not Assessed1,427
4724634/2020SP-PYRA 125PARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2020-06-24Not Assessed1,427
4734640/2020RAVZOLE-DRABEPRAZOLE SODIUM+ DOMPERIDONE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4744644/2020LUVEGRA-100SILDENAFIL CITRATE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4754631/2020FLUCOLD SYRUPPARACETAMOL+ CPM NOT APPLIED FULL ASSESSMENT 2020-06-24Pending 2st Assessment1,427
4764623/2020FLUCOLD FORTE + VITAMIN C TABSPARACETAMOL+ CAFFEINE+ PHENYLPHERINE HCL+ TERPINE HYDRATE & ASCORBIC ACID NOT APPLIED FULL ASSESSMENT 2020-06-24Pending 2st Assessment1,427
4774633/2020FLUCOLD N TABSPARACETAMOL+ CAFFEINE+ PHENYLPHERINE HCL+ CPM NOT APPLIED FULL ASSESSMENT 2020-06-24Pending 2st Assessment1,427
4784642/2020OMECENT-20OMEPRAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4794637/2020PAINRAV-SACECLOFENAC+PARACETAMOL& SERRATIOPEPTIDASE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4804624/2020ALBAMAS SUSPENSIONALBENDAZOLE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4814616/2020MOXVID-500AMOXICILLIN APPLIED FOR GMP ABRIDGED 2020-06-24Under Approval1,427
4824630/2020NOVAMENTIN-625AMOXICILLIN& CLAVULANATE POT APPLIED FOR GMP ABRIDGED 2020-06-24Under Approval1,427
4834627/2020EAZYON-500AZITHROMYCINE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending GMP 1,427
4844626/2020MAXIME-200CEFIXIME NOT APPLIED FULL ASSESSMENT 2020-06-24Not Assessed1,427
4854622/2020CLOXVID-250CLOXACILLIN APPLIED FOR GMP ABRIDGED 2020-06-24Under Approval1,427
4864641/2020LONGDAY-SDICLOFENAC POTASSIUM+ PARACETAMOL & SERRATIOPETIDASE NOT APPLIED FULL ASSESSMENT 2020-06-24Pending 2st Assessment1,427
487OXYNIR-2020OXYNIR INJOXYTOCIN APPLIED FOR GMP FULL ASSESSMENT 2020-06-27Peer Review1,424
488NIROXONE-2020NIROXONE INJCEFTRIAXONE SODIUM APPLIED FOR GMP FULL ASSESSMENT 2020-06-27Not Assessed1,424
4894841/2020NOZINAN-25LEVOMEPRAZINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-06-30Under Approval1,421
4904840/2020NOZINAN-100LEVOMEPRAZINE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-06-30Under Approval1,421
4914897/2020CALCIVITADIPHASIC CALCIUM PHOSPHATE,CALCIUM CARBONATE,VIT A,VIT D3 GMP CERTIFICATE AVAILABLE ABRIDGED 2020-07-02Not Assessed1,419
4924887/2020LIMZEROMEPRAZOLE & DOMPERIDONE APPLIED FOR GMP RECOGNITION 2020-07-02Under Approval1,419
4934907/2020MYOXERILCYCLOBENZAPRINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-02Under Approval1,419
4944985/2020EROCIN-500ERYTHROMYCINE NOT APPLIED ABRIDGED 2020-07-08Under Approval1,413
4954993/2020DOXIL-100DOXYCYCLINE HYCATE USP NOT APPLIED ABRIDGED 2020-07-08Under Approval1,413
4964984/2020EROCIN-250ERYTHROMYCINE NOT APPLIED ABRIDGED 2020-07-08Under Approval1,413
4974989/2020LEVO-R INFUSION1. Levofloxacin Hemihydrate 500mg APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending GMP 1,413
4984987/2020METRO-R INFUSIONMETRONIDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending GMP 1,413
4994988/2020PARACETAMOL INFUSIONPARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending 1st Assessment1,413
5004981/2020GLUCOSE 5% IV INFUSIONGLUCOSE ANHYDROUS APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending 1st Assessment1,413
5014983/2020CIPRO-R INFUSIONCIPROFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending GMP 1,413
5024982/2020COMPOUND SODIUM LACTATE INFUSIONCOMPOUND SODIUM LACTATE APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending GMP 1,413
5034980/2020SODIUM CHLORIDE 0.9% INFUSIONSODIUM CHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending 1st Assessment1,413
5044986/2020AZITAR-500AZITHROMYCIN NOT APPLIED ABRIDGED 2020-07-08Under Approval1,413
5054995/2020ESCORTS LEVO-72 DS TABSLEVONOGESTREL APPLIED FOR GMP FULL ASSESSMENT 2020-07-08Pending 1st Assessment1,413
5064994/2020MAXI-500 NOT APPLIED ABRIDGED 2020-07-08Under Approval1,413
5075205/2020MALAVAN-120ARTESUNATE APPLIED FOR GMP FULL ASSESSMENT 2020-07-13Pending GMP 1,408
5085207/2020FUCLO-250FLUCLOXACILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-132nd Assessment Completed 1,408
5095209/2020FUCLO-1FLUCLOXACILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13Pending 2st Assessment, ADD.DATA1,408
5105210/2020DOLIMEX MIGRAINEPARACETAMOL + CAFFEINE NOT APPLIED FULL ASSESSMENT 2020-07-132nd Assessment Completed 1,408
5115208/2020DOLIMEX-1000PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13Under Approval1,408
5125203/2020DOLIMEX-200PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13Under Approval1,408
5135206/2020DOLIMEX-500PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13Under Approval1,408
5145204/2020DOLIMEX-300PARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-13Under Approval1,408
5155212/2020SURDEXPARACETAMOL+ CAFEFEINE+ PHENYLEPHRINE + CHLORPHENIRAMINE MALEATE APPLIED FOR GMP FULL ASSESSMENT 2020-07-13Pending GMP 1,408
5165211/2020FUCLO-500FLUCLOXACILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-132nd Assessment Completed 1,408
5175247/2020MALAVAN SUPPOARTESUNATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-142nd Assessment Completed 1,407
5185329/2020EMTRICITABINE+ TENOFOVIR ALAFENAMIDEEMTRICITABINE+ TENOFOVIR ALAFENAMIDE NOT APPLIED FULL ASSESSMENT 2020-07-16Pending 1st Assessment1,405
5195429/2020 &9086/2022LIPAGLYNSAROGLITAZAR MAGNESIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-20Not Assessed1,401
5205452/2020TROGYL SUSPENSIONMETRONIDAZOLE BENZOATE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-07-21Under Approval1,400
5215477/2020TELMI-40TELMISARTAN APPLIED FOR GMP ABRIDGED 2020-07-22Pending 1st Assessment1,399
5225478/2020TELMI-80TELMISARTAN APPLIED FOR GMP ABRIDGED 2020-07-22Pending 1st Assessment1,399
5235479/2020TELMI-80 AMTELMISARTAN + AMLODIPINE APPLIED FOR GMP ABRIDGED 2020-07-22Not Assessed1,399
5245476/2020TELMI-40 AMHTELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22Pending 2st Assessment1,399
5255473/2020TELMI-80 AMHTELMISARTAN + AMLODIPINE + HYDROCHLOTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22Pending 1st Assessment1,399
5265475/2020TELMI-40 CTTELMISARTAN + CHLORTHALIDONE APPLIED FOR GMP ABRIDGED 2020-07-22Pending 2st Assessment1,399
5275470/2020TELMI-40 HTELMISARTAN + HYDROCHLOROTHIAZIDE APPLIED FOR GMP FULL ASSESSMENT 2020-07-22Pending GMP 1,399
5285472/2020TELMI-80 CTTELMISARTAN + HYDROCHLOROTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22Peer Review1,399
5295474/2020TELMI-80 HTELMISARTAN + HYDROCHLOROTHIAZIDE APPLIED FOR GMP ABRIDGED 2020-07-22Pending 2st Assessment1,399
5305471/2020TELMI-40 AMTELMISARTAN+ AMLODIPINE APPLIED FOR GMP ABRIDGED 2020-07-22Not Assessed1,399
5315508/2020ACINET 625AMOXICILLIN + CLAVULATE POTASSIUM NOT APPLIED ABRIDGED 2020-07-23Under Approval1,398
5325507/2020ACINET 1000AMOXICILLIN + CLAVULATE POTASSIUM NOT APPLIED ABRIDGED 2020-07-23Pending 2st Assessment1,398
5335509/2020ACINET DRY SYRUP 228.5MGAMOXICILLIN+ CLAVULANATE POTASSIUM NOT APPLIED ABRIDGED 2020-07-23Peer Review1,398
5345553/2020SIROFEN ORAL SUSPIBUPROFEN APPLIED FOR GMP FULL ASSESSMENT 2020-07-27Pending GMP 1,394
5355558/2020CLAVUMOCCID-1000AMOXICILLIN& POTASSIUM CLAVULANATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Pending 1st Assessment1,394
5365555/2020COFANTRINE ARTEMETER & LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Peer Review1,394
5375570/2020COFANTRINE ADULTESARTEMETHER& LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Under Approval1,394
5385565/2020COFANTRINE DISPERSIBLEARTEMETHER+ LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Under Approval1,394
5395567/2020MALAVAN 60ARTESUNATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Peer Review1,394
5405560/2020CLAVUJECT 1.2 INJECTIONCO-AMOXICLAV GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Peer Review1,394
5415541/2020MEROSAN INJECTIONMEROPENEM TRIHYDRATE & SODIUM CARBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-07-27Under Approval1,394
5425563/2020DIAFORMINE 850METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27Under Approval1,363
5435566/2020DIAFORMINE 500METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27Under Approval1,363
5445557/2020DIAFORMINE 1000METFORMIN HYDROCHLORIDE SUSTAINED RELEASE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27Under Approval1,363
5455559/2020DOLIMEX EFFERVESCENT-500PARACETAMOL NOT APPLIED FULL ASSESSMENT 2020-08-27Pending GMP 1,363
5465554/2020DOLIMEX EFFERVESCENT 1GRPARACETAMOL NOT APPLIED FULL ASSESSMENT 2020-08-27Pending GMP 1,363
5475552/2020RINOGRIPPARACETAMOL+ PHENIRAMINE MALEATE+ ASCORBIC ACID GRANULES GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27Under Approval1,363
5485556/2020RINOGRIP SANS SUCREPARACETAMOL+ PHENIRAMINE MALEATE+ ASCORBIC ACID GRANULES APPLIED FOR GMP FULL ASSESSMENT 2020-08-27Pending GMP 1,363
5495562/2020GYNOSPANPHLOROGLUCINOL& TRIMETYLPHOROGLUCINOL APPLIED FOR GMP FULL ASSESSMENT 2020-08-27Under Approval1,363
5505569/2020GYNOSPAN INJECTIONPHLOROGLUCINOL& TRIMETYLPHOROGLUCINOL APPLIED FOR GMP FULL ASSESSMENT 2020-08-27Pending 1st Assessment1,363
5515568/2020GYNOSPAN SUPPOPHLOROGLUCINOL& TRIMETYLPHOROGLUCINOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-08-27Under Approval1,363
5526318/2020VASTAREL OD 80MG PRLTRIMETAZIDINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-09-03Peer Review1,356
5536319/2020VASTAREL OD 40MG PRLTRIMETAZIDINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-09-03Peer Review1,356
5546393/2020MOVICOLPOLYETHYLENE GLYCOL/ SODIUM CHLORIDE/ SODIUM BICARBONATE/ POTASSIUM CHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2020-09-08Pending GMP 1,351
5556394/2020ZAPACID-30LANSOPRAZOLE APPLIED FOR GMP RECOGNITION 2020-09-08Rejected1,351
5566416/2020BICALUTAMIDE 150BICALUTAMIDE NOT APPLIED FULL ASSESSMENT 2020-09-08Pending GMP 1,351
5576464/2020HUMEX RHUMEPARACETAMOL/PSEDOEPHEDRINE CHLORHYDRATE IN TABET; PARACETAMOL/CHLORPHENIRAMINE MALEATE IN CAPSULE NOT APPLIED FULL ASSESSMENT 2020-09-10Pending GMP 1,349
5583913/2019& 6657/2020GRAMOCEF-O-100 DRY SYRUP, 100 MLCEFIXIME USP 100MG/5ML APPLIED FOR GMP ABRIDGED 2020-09-21Under Approval1,338
5595213/2020& 6689/2020FUCLO-500FLUCLOXACILLIN NOT APPLIED FULL ASSESSMENT 2020-09-222nd Assessment Completed 1,337
5606705/2020COARTEM 80/480MGARTEMETER & LUMEFANTRINE GMP CERTIFICATE AVAILABLE RECOGNITION 2020-09-22Peer Review1,337
5616707/2020SANDIMMUM NEORAL-25CICLOSPORIN NOT APPLIED ABRIDGED 2020-09-22Under Approval1,337
5626698/2020SANDIMMUM NEORAL-100CICLOSPORIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-09-22Under Approval1,337
5637123/2020PELASTINIMIPENEM MONOHYDRATE / CILASTATIN SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-10-13Peer Review1,316
5647122/2020SANMOLPARACETAMOL NOT APPLIED FULL ASSESSMENT 2020-10-13Pending GMP 1,316
5657124/2020PROANES 1% MCT/LCT INJECTIONPROPOFOL NOT APPLIED FULL ASSESSMENT 2020-10-13Pending GMP 1,316
5667148/2020MENOTAS HP 150MENOTROPHIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-10-14Under Approval1,315
5677264/2020PAUSE-MFTRANEXAMIC ACID+ MEFENAMIC ACID APPLIED FOR GMP FULL ASSESSMENT 2020-10-20Pending GMP 1,309
5687261/2020SEVCAR-400SEVELAMER CARBONATE APPLIED FOR GMP FULL ASSESSMENT 2020-10-20Pending GMP 1,309
5697262/2020SEVCAR-800SEVELAMER CARBONATE APPLIED FOR GMP FULL ASSESSMENT 2020-10-20Pending GMP 1,309
5707294/2020DEXO INJECTION GMP CERTIFICATE AVAILABLE ABRIDGED 2020-10-21Under Approval1,308
5717382/2020ISONIAZIDISONIAZID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-10-26Peer Review1,303
5727383/2020ARTESUNATE POWDER FOR INJARTESUNATE NOT APPLIED FULL ASSESSMENT 2020-10-26Pending GMP 1,303
5737622/2020LOMOH 40ENOXAPARIN SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 2020-11-042nd Assessment Completed 1,294
5747619/2020MOFILET S 360MYCOPHENOLATE SODIUM APPLIED FOR GMP FULL ASSESSMENT 2020-11-04Not Assessed1,294
5757664/2020EMEFILM-4ONDANSENTRON HYDROCHLORIDE DIHYDRATE NOT APPLIED FULL ASSESSMENT 2020-11-05Pending GMP 1,293
5765564/2020 & 7904/2020LUFANTERARTEMETHER+ LUMEFANTRINE APPLIED FOR GMP FULL ASSESSMENT 2020-11-19Peer Review1,279
5775214/2020& 7905/2020TRACEDOLTRAMADOL + PARACETAMOL NOT APPLIED FULL ASSESSMENT 2020-11-19Pending 1st Assessment1,279
5787928/2020KAREMOX-500AMOXICILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-11-19Peer Review1,279
5797924/2020KAREMOX-250AMOXICILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-11-19Peer Review1,279
5807951/2020Jadelle 2 x 75 mg implantsLevonorgestrel NOT APPLIED RECOGNITION 2020-11-20Under Approval1,278
5817952/2020Mirena Levonorgestrel NOT APPLIED RECOGNITION 2020-11-20Under Approval1,278
5827949/2020ASPIRIN CARDIOACETYLSALICYLIC ACID GMP CERTIFICATE AVAILABLE RECOGNITION 2020-11-20Under Approval1,278
5837959/2020MICROGYNON ED FEETHINYLESTRADIOL/ LEVONOGESTREL APPLIED FOR GMP ABRIDGED 2020-11-20Under Approval1,278
5847954/2020NORIGYNONNORETHISTERONE ENANTATE AND ESTRADIOL VALERATE APPLIED FOR GMP ABRIDGED 2020-11-20Under Approval1,278
5858037/2020CIPYNE CAPSULESPARACETAMOL/ IBUPROFEN/ CODEINE PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-11-25Under Approval1,273
5868037/2020CORILIEF NON DROWSY TABLETSPARACETAMOL/ PSEUDOEPHEDRINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-11-25Pending 1st Assessment1,273
5878037/2020 8037/2019NEUTRAGEL SUSPENSIONMAGNESIUM HYDROXIDE/ ALUMINIUM HYDROXIDE/ SIMETHICONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-11-25Not Assessed1,273
588EBUCAF-2020EBUCAFIBUPROFEN APPLIED FOR GMP FULL ASSESSMENT 2020-12-03Pending 1st Assessment1,265
5898538/2020FLAGENTYLSECNIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-17Under Approval1,251
5908593/2020DAWACORT CREAMHYDROCORTISONE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21Not Assessed1,247
5918591/2020ETROSIDE ETORICOXIB+THIOCOLCHICOSIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21Not Assessed1,247
5928607/2020DOXANOR GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
5938615/2020TENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIRTENOFOVIR DISOPROXIL FUMARATE/ LAMIVUDINE/ DOLUTEGRAVIR NOT APPLIED FULL ASSESSMENT 2020-12-21Not Assessed1,247
5948582/2020NERVILIN NTPREGABALIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
5958581/2020IBUPAR CAPLETS GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
5968624/2020LORI-DIAZEPAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21Under Approval1,247
5978617/2020DUCARPRINE 200CIMETIDINE APPLIED FOR GMP FULL ASSESSMENT 2020-12-21Not Assessed1,247
5988605/2020ELMOX 125AMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2020-12-21Pending 2st Assessment, ADD.DATA1,247
5998610/2020AMOXIMED 250AMOXICILLIN NOT APPLIED RECOGNITION 2020-12-21Under Approval1,247
6008618/2020AMOXIMED 500AMOXICILLIN NOT APPLIED RECOGNITION 2020-12-21Under Approval1,247
6018589/2020DAWA-CPM SYRUPCHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6028608/2020FASTACT GELDICLOFENAC DIETHYLAMINE/ MRTHYL SALICYLATE/ MENTHOL GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6038572/2020LEDIPASVIR+ SOFOSBUVIRLEDIPASVIR+ SOFOSBUVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21Pending 1st Assessment1,247
6048601/2020MOXAFORTE CAPSULESFLUCLOXACILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Not Assessed1,247
6058595/2020FEE PETHIDINE INJECTIONPETHIDINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-21Not Assessed1,247
6068611/2020AMPIMED 500 APPLIED FOR GMP FULL ASSESSMENT 2020-12-212nd Assessment Completed 1,247
6078604/2020ELMOX 250 SYRUPAMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2020-12-212nd Assessment Completed 1,247
6088613/2020ELMOX 250AMOXICILLIN APPLIED FOR GMP ABRIDGED 2020-12-21Under Approval1,247
6098600/2020DAWAVATE CREAMBETAMETHASONE VALEARATE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6108578/2020IBUPAR SUSPENSION GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
6118596/2020VERMOUT SUSPENSIONMEBENDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6128592/2020DAWASTIN SUSPENSION GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6138580/2020TRIMOXOL SUSPENSIONSULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
6148583/2020DACOLD SUSPENSIONPARACETAMOL/ PSEUDOEPHEDRINE HYDROCHLORIDE/ CHLORPROMAZINE MALEATE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6158602/2020GRIPE WATER LIQUID GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6168598/2020DAWAVITE SYRUPMULTIVITAMINS GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6178599/2020JUNIOR ZINC TABLETSZINC SULPHATE MONOHYDRATE USP GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
6188621/2020WOMNIL SUSPENSIONALBENDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
6198620/2020WHITFIELD'S OINTMENTSALICYLIC ACID AND BENZOIC ACID GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6208622/2020DACINAZOLE CREAMMICONAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21To Update Dossier1,247
6218612/2020CLOXISEL 500 APPLIED FOR GMP ABRIDGED 2020-12-212nd Assessment Completed 1,247
6228594/2020MOXAFORTE SUSPENSIONFLUCLOXACILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-21Under Approval1,247
6238710/2020LOTENZ AHLOSARTAN POTASSIUM/AMLODIPINE/ HYDROCHLORTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-23Under Approval1,245
6248709/2020LOTENZ ALOSARTAN POTASSIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-23To Update Dossier1,245
6258761/2020MUCOLYN SYRUPAMMONIUM CHLORIDE/ BROMHEXINE HYDROCHLORIDE/ CHLORPHENIRAMINE MALEATE/ DEXTROMETHORPHAN HYDROBROMIDE NOT APPLIED RECOGNITION 2020-12-24Under Approval1,244
6268758/2020ENO CALCIUM ANTI-ACIDCALCIUM CARBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-24Pending 1st Assessment, ADD.DATA1,244
6278750/2020BETADINE STANDARDISED MICROBICIDAL SOLUTION 5%POVIDONE- IODINE USP APPLIED FOR GMP RECOGNITION 2020-12-24Under Approval1,244
6288749/2020BETADINE ANTISEPTIC CREAM 5%POVIDONE- IODINE USP APPLIED FOR GMP RECOGNITION 2020-12-24Under Approval1,244
6298762/2020PED ZINC TABLETZINC SULPHATE MONOHYDRATE USP APPLIED FOR GMP ABRIDGED 2020-12-24Under Approval1,244
6308800/2020NITROCONTIN 6.4DILUTED NITROGYCERIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-292nd Assessment Completed 1,239
6318833/2020SERETIDE 50/250MCG DISKUSSALMETEROL XINAFOATE MICRONIZED /FLUTICASONE PROPRIONATE MICRONIZED GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30Under Approval1,238
6328835/2020SERETIDE 50/100MCG DISKUSSALMETEROL XINAFOATE MICRONIZED/FLUTICASONE PROPRIONATE MICRONIZED GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30Under Approval1,238
6338836/2020SERETIDE 50/500MCGSALMETEROL XINAFOATE/FLUTICASONE PROPRIONATE GMP CERTIFICATE AVAILABLE RECOGNITION 2020-12-30Under Approval1,238
6348829/2020KETACON CREAMKETOCONAZOLE APPLIED FOR GMP FULL ASSESSMENT 2020-12-30Pending GMP 1,238
6358830/2020 8130/2020ALBENDO SUSPENSION 100MLALBENDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2020-12-30Not Assessed1,238
6368831/2020ALBENDO 400MGALBENDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2020-12-30Pending GMP 1,238
6378842/2020AUGMENTIN 500/62.5MGAMOXICILLIN /CLAVULANIC ACID APPLIED FOR GMP ABRIDGED 2020-12-30Under Approval1,238
6388859/2020CLARICIN-500CLARITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-30Queried_Assessment-Round11,238
6398876/2020DAKASVIRDACLATASVIR DIHYDROCLORIDE NOT APPLIED FULL ASSESSMENT 2020-12-302nd Assessment Completed 1,238
6408877/2020BONCARE PLUSMETHYLSULFONYLMETHANE/ GLUCOSAMINE SULPHATE POTASSIUM CHLORIDE/ CHONDROITIN SULPHATE SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2020-12-30Under Approval1,238
6418860/2020SSBSOFOSBUVIR NOT APPLIED FULL ASSESSMENT 2020-12-30Not Assessed1,238
6428622/2020DACINAZOLE CREAMIMIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2020-12-31Not Assessed1,237
6430154/2021GYNEPILL LEVONORGESTREL NOT APPLIED FULL ASSESSMENT 2021-01-11Pending 2st Assessment, ADD.DATA1,226
6440141/2021DYGLI M 50/1000SITAGLIPTIN + METFORMIN HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-11Queried_Assessment-Round11,226
6450286/2021TRIALGIC IBUPROFEN/ PARACETAMOL/ CAFFEINE NOT APPLIED ABRIDGED 2021-01-142nd Assessment Completed 1,223
6460227/2021POVIDONE IODEE IG (500ML)POVIDONE IODEE NOT APPLIED FULL ASSESSMENT 2021-01-14Not Assessed1,223
6470248/2021RIPAXIL-750CEFUROXIME AXETIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6480228/2021POVIDONE IODEE IG (125ML)POVIDONE IODEE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6490229/2021GYNOFASTCLINDAMYCIN/ CLOTRIMAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6500223/2021CLOMIFENE IGCLOMIFEN BP APPLIED FOR GMP FULL ASSESSMENT 2021-01-14Not Assessed1,223
6510246/2021GYNANFORTMETRONIDAZOLE/ NEOMYCIN/ NYSTATIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6520252/2021GYNOFER-B12CITRATE D'AMMONIUM FERRIQUE/ ACIDE FOLIQUE/ VITAMINE B12 GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6530245/2021UPRAJECT-40PANTOPRAZOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6540243/2021LOFNAC GELDICLOFENAC SODIUM NOT APPLIED FULL ASSESSMENT 2021-01-14Pending GMP 1,223
6550247/2021CLAVUMOCCID-1GAMOXICILLIN/POTASSIUM CLAVULANATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6560234/2021DIARTEM IGDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6570238/2021DIARTEM IG SUSPDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6580237/2021CARBEN-DRINKABLE SUSPMEBENDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6590241/2021CLAVUMOCCID SUSPAMOXICILLIN/POTASSIUM CLAVULANATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Not Assessed1,223
6600239/2021CLAVUMOCCID-500AMOXICILLIN/POTASSIUM CLAVULANATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6610232/2021DIARTEM IG ADULTDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-142nd Assessment Completed 1,223
6620240/2021LOPINE-10AMLODIPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Peer Review1,223
6630223/2021AZITRINE-250AZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Peer Review1,223
6640244/2021AZITRINE-500AZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Peer Review1,223
6650250/2021CEFTRIAXONE IGCEFTRIAXONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-01-14Pending 2st Assessment, ADD.DATA1,223
6660348/2021TOCIMEXAMOXICILLIN TRIHYDRATE/ AMBROXOL HYDROCHLORIDE NOT APPLIED FULL ASSESSMENT 2021-01-18Pending GMP 1,219
6670339/2021ALERBIXBILASTINE NOT APPLIED FULL ASSESSMENT 2021-01-18Not Assessed1,219
6680347/2021ALBERBIX-10BILASTINE NOT APPLIED FULL ASSESSMENT 2021-01-18Pending GMP 1,219
6690341/2021ACTIMAGMAGNESIUM PIDOLATE NOT APPLIED ABRIDGED 2021-01-18Under Approval1,219
6700351/2021ALERBIX-20BILASTINE NOT APPLIED FULL ASSESSMENT 2021-01-18Pending GMP 1,219
6710338/2021DESARROL 200MLCYPROPEPTADINE/ CARNITINE HCL/ ARGININE ASPARTATE NOT APPLIED ABRIDGED 2021-01-182nd Assessment Completed 1,219
6720343/2021TRAUSAN 50ML CITICHOLONE NOT APPLIED ABRIDGED 2021-01-18Under Approval1,219
6730342/2021TOCIMEX 90MLAMOXICILLIN TRIHYDRATE/ AMBROXOL HYDROCHLORIDE NOT APPLIED FULL ASSESSMENT 2021-01-18Not Assessed1,219
6740594/2021LUTENYL 5MGNOMEGESTROL ACETATE NOT APPLIED RECOGNITION 2021-01-29Under Approval1,208
6750593/2021ANTADYSFLURBIPROFEN NOT APPLIED ABRIDGED 2021-01-29Under Approval1,208
6760577/2021THERMODOLPARACETAMOL NOT APPLIED FULL ASSESSMENT 2021-01-29Not Assessed1,208
6770578/2021UNOKETROKETOROLAC TROMETHAMINE NOT APPLIED FULL ASSESSMENT 2021-01-29Not Assessed1,208
678HYDOPA-2021HYDOPAMETHYLDOPA GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
679ZEROCIN-2021ZEROCINAZITHROMYCIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
680KEMOXYL-2021KEMOXYL SYRUPAMOXICILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
681CHALEATE-2021CHALEATE SYRUPCHLORPHENIRAMINE MALEATE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
682EUVITAN-2021EUVITAN SYRUPMULTIVITAMINS GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
683CAPTOLAB-2021CAPTOLAB TABCAPTOPRIL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
684LABSTATIN-2021LABSTATINNYSTATIN USP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
685ASPIRINTAB-2021ASPIRIN 500 TABASPIRIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-03To Update Dossier1,203
6860897/2021RABEZOLRABEPRAZOLE SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-02-11Pending 2st Assessment, ADD.DATA1,195
6870906/2021VANTOX CP 1GVANCOMYCIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-11Under Approval1,195
6880894/2021RHINOPAROLPARACETAMOL/ PHENYLEPHRINE HYDROCHLORIDE/ CHLORPHENIRAMINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-02-11Not Assessed1,195
6890937/2021LORHISTINA SYRUPLORATADINE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-12Under Approval1,194
6900938/2021PRAZITEL 600MGPRAZIQUANTEL GMP CERTIFICATE AVAILABLE RECOGNITION 2021-02-12Under Approval1,194
6910939/2021TRIBEES FORTE VITAMIN B1+ VITAMIN B6+ VITAMIN B12 GMP CERTIFICATE AVAILABLE ABRIDGED 2021-02-12Pending 1st Assessment1,194
6920933/2021MELANEZ 1GMESALAZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-02-12Under Approval1,194
6931065/2021CLOXARIN-250CLOXACILLIN APPLIED FOR GMP FULL ASSESSMENT 2021-02-182nd Assessment Completed 1,188
6941068/2021CLOXARIN-500CLOXACILLIN APPLIED FOR GMP FULL ASSESSMENT 2021-02-18Pending 1st Assessment, ADD.DATA1,188
6951066/2021HALOSAN-DHALOPERIDOL DECANOATE APPLIED FOR GMP FULL ASSESSMENT 2021-02-18Not Assessed1,188
6961063/2021ZEE-1LEVONORGESTREL APPLIED FOR GMP ABRIDGED 2021-02-18Under Approval1,188
6971060/2021ATOSAR-HLOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE APPLIED FOR GMP FULL ASSESSMENT 2021-02-18Under Approval1,188
6981059/2021SOLOCEF-1000MGCEFTRIAXONE APPLIED FOR GMP FULL ASSESSMENT 2021-02-18Pending GMP 1,188
6991346/2021ACUPANNEFOPAM NOT APPLIED RECOGNITION 2021-03-03Under Approval1,175
7001344/2021ULTRA-LEVULE SACHETSSACCHAROMYCES BOULARDII NOT APPLIED FULL ASSESSMENT 2021-03-03Not Assessed1,175
7011386/2021LUMITER 80/480ARTEMETHER+ LUMEFANTRINE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-03-04Under Approval1,174
7021541/2021CHLOROMYCETIN-250CHLORAMPHENICOL APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7031532/2021SCOTRAM-100TRAMADOL HYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7041540/2021TEGRIX-200CARBAMAZEPINE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7051536/2021HYOMIDE-10HYOSCINE BUTYLBROMIDE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Pending 2st Assessment1,168
7061538/2021CIPROSCOT 500CIPROFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7071539/2021IBUPLUSIBUPROFEN NOT APPLIED ABRIDGED 2021-03-10Peer Review1,168
7081427/2021SANGFERIRON SUCROSE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Pending GMP 1,168
7091425/2021FLUXOLFLUPENTIXOL APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Pending GMP 1,168
7101535/2021PIRICAM-20PIROXICAM APPLIED FOR GMP RECOGNITION 2021-03-10Under Approval1,168
7111534/2021SCODOPA-250METHYLDOPA APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7121426/2021SAN PHYSIO-SPRAYSODIUM CHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2021-03-10Not Assessed1,168
7131616/2021JUSTEEZ-50VILDAGLIPTIN APPLIED FOR GMP FULL ASSESSMENT 2021-03-15Not Assessed1,163
7141619/2021CALOSHELL-500CALCIUM+COLECALCIFEROL APPLIED FOR GMP ABRIDGED 2021-03-15Under Approval1,163
7151533/2021& 1798/2021DOXYSCOT-100DOXYCYCILIN HYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-03-22Not Assessed1,156
7161909/2021ALLERCET MMONTELUKAST/ LEVOCETRIZINE DIHYROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-03-25Not Assessed1,153
7171918/2021DAPZIN 5-M PLUSDAPAGLIFLOZIN AND EXTENDED RELEASE METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-03-25Not Assessed1,153
7181916/2021SUVIRTA-750LEVETIRACETAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-03-25Not Assessed1,153
7192029/2021GOFAZTNAPROXEN SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-03-29Pending 1st Assessment, ADD.DATA1,149
7202112/2021OFZOLE 30 TABSOFLOXACIN + ORNIDAZOLE APPLIED FOR GMP ABRIDGED 2021-03-31Under Approval1,147
7212113/2021NAC MR 10 TABSDICLOFENAC POTASSIUM/PARACETAMOL/ CHLORZOXANE APPLIED FOR GMP ABRIDGED 2021-03-31Under Approval1,147
722Via-emailMETAGO-500METRONIDAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-03To Update Dossier1,144
7232255/2021POLYNYCINNEOMYCIN SULPHATE/POLYMYXIN B SULPHATE/ NYSTATIN APPLIED FOR GMP FULL ASSESSMENT 2021-04-06Not Assessed1,141
7242252/2021CAREVATINIDAZOLE/ MICONAZOLE/NEOMYCIN APPLIED FOR GMP FULL ASSESSMENT 2021-04-06Not Assessed1,141
7252254/2021ULSACURE (H.PYLORI KIT)COMBIPACK OF LANSOPRAZOLE/CLARITHROMYCINE/ TINIDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-04-06Not Assessed1,141
7262340/2021ALCOF-C SIROPDEXTROMETHORPHAN/ CETREZINE/ PHENYLEPHERINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-09Under Approval1,138
7272738/2021SINAREST PAEDIATRIC NASAL DROPSOXYMETHAZOLINE HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-20Under Approval1,127
7282736/2021LOSATRUST 50LOSARTAN POTASSIUM GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-20Peer Review1,127
7292731/2021LOSATRUST HLOSARTAN POTASSIUM/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-20Under Approval1,127
7302799/2021TOFF-DCDEXTROMETHORPHAN HYDROBROMIDE/ CHLORPHENAMINE MALEATE/ PHENYLEPHRINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-21Not Assessed1,126
7312798/2021WILLGO CR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-21Pending 1st Assessment, ADD.DATA1,126
7322933/2021MYGLIP-5LINAGLIPTIN APPLIED FOR GMP FULL ASSESSMENT 2021-04-26Pending 1st Assessment, ADD.DATA1,121
7332935/2021MYGLIP PLUS 2.5/850LINAGLIPTIN/METFORMIN HYDROCHLORIDE NOT APPLIED RECOGNITION 2021-04-26Peer Review1,121
7342934/2021MYGLIP PLUS 2.5/500LINAGLIPTIN/METFORMIN HYDROCHLORIDE NOT APPLIED FULL ASSESSMENT 2021-04-26Pending 1st Assessment1,121
7352932/2021MYGLIP PLUS 2.5/1000LINAGLIPTIN/METFORMIN HYDROCHLORIDE NOT APPLIED FULL ASSESSMENT 2021-04-26Pending 1st Assessment1,121
7360224/2021& 2941/2021DAREXYL 3GDIOSMECTITE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-26Not Assessed1,121
737DYNAMOGEN-2021DYNAMOGEN ARGININE ASPARTATE NOT APPLIED RECOGNITION 2021-04-27Under Approval1,120
7383031/2021OMEPRAGLOBE OMEPRAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-04-28To Update Dossier1,119
7390226/2021& 2940/2021AZITRINEAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-04-29Not Assessed1,118
7403200/2021VASTERN 25CINNARIZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-05-042nd Assessment Completed 1,113
7413252/2021DRENOXOL 30MG/10MLAMBROXOL APPLIED FOR GMP FULL ASSESSMENT 2021-05-06Pending 1st Assessment1,111
7423249/2021YENDOL NPARACETAMOL/ CAFFEINE/ CHLORPHENIRAMINE MALEATE NOT APPLIED FULL ASSESSMENT 2021-05-06Pending 1st Assessment1,111
7433251/2021FLONIX 500LEVOFLOXACIN NOT APPLIED FULL ASSESSMENT 2021-05-06Pending 2st Assessment1,111
7443250/2021TRAUSAN 500MG/2MLCITICOLINE SODIUM APPLIED FOR GMP FULL ASSESSMENT 2021-05-06Not Assessed1,111
7453248/2021DRENOXOL 3MG/MLAMBROXOL APPLIED FOR GMP FULL ASSESSMENT 2021-05-06Pending 1st Assessment1,111
7463247/2021GABAR 75MGPREGABALIN NOT APPLIED FULL ASSESSMENT 2021-05-06Pending GMP 1,111
7473253/2021TORSEC 30MG SACHETSRACECADOTRIL NOT APPLIED FULL ASSESSMENT 2021-05-06Pending GMP 1,111
7483255/2021TORSEC 10MG SACHETSRACECADOTRIL NOT APPLIED FULL ASSESSMENT 2021-05-06Pending GMP 1,111
7493254/2021GABAR 25MGPREGABALIN APPLIED FOR GMP FULL ASSESSMENT 2021-05-06Pending 1st Assessment1,111
7503349/2021AMOXI-DENK 500AMOXICILLIN TRIHYDRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2021-05-10Pending 1st Assessment1,107
7513356/2021DICLO-DENK 100 RETARDDICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 2021-05-10Rejected1,107
7523446/2021DISLEP 25MGLEVOSULPIRIDE NOT APPLIED RECOGNITION 2021-05-14Under Approval1,103
7533516/2021EKAPRIL 2.5RAMPIPRIL NOT APPLIED FULL ASSESSMENT 2021-05-17Pending 2st Assessment1,100
7543650/2021TENOFOVIRTENOFOVIR APPLIED FOR GMP FULL ASSESSMENT 2021-05-20Not Assessed1,097
7553646/2021DOLUTEGRAVIRDOLUTEGRAVIR APPLIED FOR GMP FULL ASSESSMENT 2021-05-20Not Assessed1,097
7563644/2021LOPINAVIR& RITONAVIRLOPINAVIR& RITONAVIR APPLIED FOR GMP ABRIDGED 2021-05-20Not Assessed1,097
7573645/2021ABACAVIR AND LAMIVUDINE TABLETS USP 600/300MGABACAVIR AND LAMIVUDINE TABLETS USP 600/300MG GMP CERTIFICATE AVAILABLE ABRIDGED 2021-05-20Under Approval1,097
7583649/2021TENOFOVIR/LAMIVUDINETENOFOVIR/LAMIVUDINE APPLIED FOR GMP ABRIDGED 2021-05-20Under Approval1,097
7593648/2021DOLUTEGRAVIR/LAMIVIDUNE/ TENOFOVIRDOLUTEGRAVIR/LAMIVIDUNE/ TENOFOVIR APPLIED FOR GMP ABRIDGED 2021-05-20Pending 2st Assessment1,097
7603647/2021LAMIVUDINE/ZIDOVUDINE LAMIVUDINE/ZIDOVUDINE APPLIED FOR GMP ABRIDGED 2021-05-20Under Approval1,097
7613663/2021EMTRICITABINE/ TENOFOVIR DFEMTRICITABINE/ TENOFOVIR DF APPLIED FOR GMP ABRIDGED 2021-05-20Under Approval1,097
7623720/2021CLAMOXYL 500MGAMOXICILLIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-05-24Under Approval1,093
7633749/2021GLICOR MR 60MGGLICLAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-05-252nd Assessment Completed 1,092
764TENA-2021TENA-100ATENOLOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-05-28Not Assessed1,089
7653883/2021TRD-CONTIN 100TRAMADOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-05-31Under Approval1,086
7663916/2021CLOXA 250CLOXACILLIN SODIUM APPLIED FOR GMP FULL ASSESSMENT 2021-06-01Pending GMP 1,085
7673917/2021CLOXA 500CLOXACILLIN SODIUM APPLIED FOR GMP FULL ASSESSMENT 2021-06-01Pending GMP 1,085
7684016/2021AGOLACTONE-25 SPIRONOLACTONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03Under Approval1,083
7694025/2021PYLORELIEF OINTMENTBETAMETHASONE VALERATE/ PHENYLEPHRINE HCL/ LIDOCAINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03Not Assessed1,083
7704015/2021AGODIC GELDICLOFENAC GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03Under Approval1,083
7714021/2021LEVOMEPROMAZINE TABLETLEVOMEPROMAZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-03Not Assessed1,083
7724004/2021AGO-C 500 TABLETASCORBIC ACID GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-03Under Approval1,083
7734003/2021OLAPIN-5OLANZAPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-032nd Assessment Completed 1,083
7744013/2021AGOMIDE TABLETFUROSEMIDE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-03Under Approval1,083
7754240/2021NAC SP 10 TABLETDICLOFENAC POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2021-06-11Not Assessed1,075
7764240/2021IZ 500MG TABLETAZITHROMYCIN APPLIED FOR GMP FULL ASSESSMENT 2021-06-11Not Assessed1,075
7774285/2021SKDERM CREAMBETAMETHASONE DIPROPRIONATE/ CLOTRIMAZOLE & GENTAMICIN SULFATE GMP CERTIFICATE AVAILABLE RECOGNITION 2021-06-14Under Approval1,072
7784283/2021NEOMYCIN SULFATENEOMYCIN SULFATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-142nd Assessment Completed 1,072
7794336/2021VOLTFASTDICLOFENAC POTASSIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-06-16Under Approval1,070
7804347/2021DESLORATOR-5DESLORATADINE APPLIED FOR GMP FULL ASSESSMENT 2021-06-17Pending 2st Assessment1,069
7814582/2021AMOXYL 250AMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2021-06-24Pending GMP 1,062
7824521/2021AMOXYL 500AMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2021-06-24Pending GMP 1,062
7834626/2021CIMESALCIMETIDINE NOT APPLIED FULL ASSESSMENT 2021-06-25Not Assessed1,061
7844798/2021PARACETAMOL B.BRAUN 10MG/ML SOLUTION FOR INFUSIONPARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-06-30Pending 2st Assessment1,056
7855071/2021CLINICEF CV DTCEFIXIME AND CLAVULANIC ACID NOT APPLIED FULL ASSESSMENT 2021-07-14Not Assessed1,042
7865072/2021CLASSMOX DROPSAMOXICILLIN NOT APPLIED FULL ASSESSMENT 2021-07-14Not Assessed1,042
7875055/2021LOTEM SUSPENSIONIBUPROFEN/ PARACETAMOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-07-14Under Approval1,042
7885070/2021CLINICEF CVCEFIXIME/ CLAVULANIC ACID NOT APPLIED FULL ASSESSMENT 2021-07-14Not Assessed1,042
7895137/2021AAVAM 156 MG AMOXYCILLIN TRIHYDRATE+DILUTED POTASSIUM CLAVULANATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-16Not Assessed1,040
7905137/2021BAMNA CLOXA AMPICILLIN TRIHYDRATE+CLOXACILLIN SODIUM APPLIED FOR GMP FULL ASSESSMENT 2021-07-16Not Assessed1,040
7915137/2021CAVAM 375MGAMOXYCILLIN TRIHYDRATE+DILUTED POTASSIUM CLAVULANATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-16Not Assessed1,040
7925137/2021DAVAM 625MGAMOXYCILLIN TRIHYDRATE+DILUTED POTASSIUM CLAVULANATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-16Not Assessed1,040
7935137/2021EMOXITAM 125MG SUSPENSIONAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-162nd Assessment Completed 1,040
7945137/2021FMOXITAM 250MG CAPSULEAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-162nd Assessment Completed 1,040
7955137/2021GMOXITAM 250MG SUSPENSIONAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-162nd Assessment Completed 1,040
7965137/2021HMOXITAM 500MG CAPSULESAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-07-162nd Assessment Completed 1,040
7975118/2021PIRODENE 20PIROXICAM APPLIED FOR GMP FULL ASSESSMENT 2021-07-16Not Assessed1,040
7985117/2021UTRORONE 100PROGESTERONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-07-162nd Assessment Completed 1,040
7995136/2021DOLUTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE DOLUTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-07-16Pending 1st Assessment1,040
8005217/2021APDROPS DXMOXIFLOXACIN WITH DEXAMETHASONE APPLIED FOR GMP FULL ASSESSMENT 2021-07-21Not Assessed1,035
8015214/2021SOFTDROPSCARBOXYMETHYL CELLULOSE SODIUM AND GLYCERIN APPLIED FOR GMP FULL ASSESSMENT 2021-07-21Pending GMP 1,035
8025218/2021OLOPAT ODOLOPATADINE HYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2021-07-21Pending GMP 1,035
8035215/2021BIMATBIMATOPROST APPLIED FOR GMP FULL ASSESSMENT 2021-07-21Not Assessed1,035
8045216/2021NEPAFLAMNEPAFENNAC APPLIED FOR GMP FULL ASSESSMENT 2021-07-21Not Assessed1,035
8055421/2021UTRORONE 200PROGESTERONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-02Pending 1st Assessment1,023
8065487/2021AZBACT 500AZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-04Pending 1st Assessment1,021
8075520/2021AZACITIDINE NEAPOLISAZACITIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-05Peer Review1,020
8085614/2021BUCOSINE-GBUTYLBROMIDE NOT APPLIED FULL ASSESSMENT 2021-08-10Pending 2st Assessment1,015
809 5605/2021MOFILET-500MYCOPHENOLATE MOFETIL USP APPLIED FOR GMP FULL ASSESSMENT 2021-08-10Pending GMP 1,015
8105616/2021BUPINAC-G HEAVYBUPIVACAINE HYDROCHLORIDE/ DEXTROSE NOT APPLIED FULL ASSESSMENT 2021-08-10Not Assessed1,015
8115604/2021EMITRICITABINE/ TENOFOVIR ALAFENAMIDEEMITRICITABINE/ TENOFOVIR ALAFENAMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-10Not Assessed1,015
8125602/2021EAZY PILLLEVONORGESTREL BP APPLIED FOR GMP FULL ASSESSMENT 2021-08-10Not Assessed1,015
8135615/2021SETRON-GONDANSETRON NOT APPLIED FULL ASSESSMENT 2021-08-10Not Assessed1,015
8145633/2021LOXAPARIN 40ENOXAPARIN NOT APPLIED FULL ASSESSMENT 2021-08-11Not Assessed1,014
8155694/2021XREYIMAGE IODINE NOT APPLIED FULL ASSESSMENT 2021-08-13Not Assessed1,012
8165702/2021FC-ZOLE 200FLUCONAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8175708/2021EMITOSS INJECTIONONDANSENTRON HYDROCHLORIDE DIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8185707/2021EMITOSS SOLUTIONONDANSENTRON HYDROCHLORIDE DIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8195697/2021FLUCOLDEX-E SUSPENSIONPARACETAMOL/CHLORPHENAMINE MALEATE/PHENYLEPHRINE HCL APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8205701/2021SENIDOLSECNIDAZOLE APPLIED FOR GMP ABRIDGED 2021-08-13Under Approval1,012
8215706/2021FLUCOLDEX COLD + FLU TABLETPARACETAMOL/ PHENYLEPHRINE HCL/ CAFFEINE/ CHLORPHENIRAMINE MALEATE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8225696/2021FC-ZOLE 150FLUCONAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8235695/2021AZITHROSAFE TABLETSAZITHROMYCIN APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8245699/2021NIL WORM TABLETSALBENDAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Pending 2st Assessment1,012
8255698/2021RELIPOIETIN 4000IUERYTHROPOIETIN APPLIED FOR GMP FULL ASSESSMENT 2021-08-13Not Assessed1,012
8265870/2021PANFOR PR-500MG METFORMIN HYDROCHLORIDE APPLIED FOR GMP RECOGNITION 2021-08-19Under Approval1,006
8275879/2021RISPER-2 TABLETSRISPERIDONE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8285881/2021METCLO TABLETSMETOCLOPRAMIDE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-192nd Assessment Completed 1,006
8295886/2021GALLOP CAPSULESLOPERAMIDE HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-192nd Assessment Completed 1,006
8305887/2021FEROL TABLETSDRIED FERROUS SULPHATE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8315888/2021FEF TABLETS DRIED FERROUS SULPHATE BP +FOLIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8325889/2021COLD-A-GO CAPSULESPARACETAMOL+PHENYLEPHRINE HCL+DIPHENHYDRAMINE HCL+CAFFEINE ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8335891/2021AZ-500AZITHROMYCIN DIHYDRATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-192nd Assessment Completed 1,006
8345900/2021AGO-CPMCHLORPHENIRAMINE MALEATE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Under Approval1,006
8355904/2021D-LYTE ORSANHYDROUS GLUCOSE BP+SODIUM CHLORIDE BP+ TRISODIUM CITRATE DIHYDRATE BP+POTASSIUM CHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8365906/2021CHLOZINE TABLETSCHLORPROMAZINE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-192nd Assessment Completed 1,006
8375912/2021AGODINE -TSPOVIDONE IODINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Under Approval1,006
8385920/2021NYSTAGO TABLETSNYSTATIN BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8395898/2021AGOMOL-100 TABLETSPARACETAMOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Under Approval1,006
8405899/2021AGOCID SUSPENSIONDRIED ALUMINIUM HYDROXIDE GEL +MAGNESIUM HYDROXIDE+SIMETHICONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-19Not Assessed1,006
8415902/2021PROMAGO SYRUPPROMETHAZINE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-08-192nd Assessment Completed 1,006
8425873/2021FLOEZYTAMSULOSIN HYDROCHLORIDE NOT APPLIED RECOGNITION 2021-08-19Under Approval1,006
8435883/2021TIN-TIN TABLETSTINIDAZOLE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-08-192nd Assessment Completed 1,006
8445939/2021ABZOLEALBENDAZOLE NOT APPLIED FULL ASSESSMENT 2021-08-20Pending 2st Assessment1,005
8456042/2021SPAMOX 500 CAPSULESAMOXICILLIN APPLIED FOR GMP RECOGNITION 2021-08-24Under Approval1,001
8466044/2021SPOTCLAVOSAMOXICILLIN+CLAVULANATE POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2021-08-24Not Assessed1,001
8476046/2021SPAMOX ORAL SUSPENSION 250MGAMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 2021-08-24Not Assessed1,001
8486047/2021CLOXISPA 500 CAPSULESCLOXACILLIN SODIUM APPLIED FOR GMP FULL ASSESSMENT 2021-08-24Not Assessed1,001
8496498/2021DARUNAVIR/RITONAVIRDARUNAVIR/ RITONAVIR APPLIED FOR GMP FULL ASSESSMENT 2021-09-022nd Assessment Completed 992
8506557/2021PERINAM DENK 4/5MGPERINDOPRIL& AMLODIPINE NOT APPLIED RECOGNITION 2021-09-03Pending 1st Assessment991
8516556/2021PERINAM DENK 8/10MGPERINDOPRIL& AMLODIPINE NOT APPLIED RECOGNITION 2021-09-03Pending 1st Assessment991
8526560/2021DICLO-DENK 100 RETARD SUPPODICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 2021-09-03Peer Review991
8536563/2021PERINAM DENK 8/5MGPERINDOPRIL& AMLODIPINE NOT APPLIED RECOGNITION 2021-09-03Pending 1st Assessment991
8546558/2021AMVA DENK 10/160MGAMLODIPINE/ VALSARTAN NOT APPLIED RECOGNITION 2021-09-03Under Approval991
8557047/2021ALBURELHUMAN ALBUMIN SOLUTION BP NOT APPLIED ABRIDGED 2021-09-15Peer Review979
8567130/2021EDGEFORCETADALAFIL APPLIED FOR GMP FULL ASSESSMENT 2021-09-17Not Assessed977
8577128/2021PROXIB CELECOXIB NOT APPLIED FULL ASSESSMENT 2021-09-17Not Assessed977
8587132/2021EDZOLIDLINEZOLID APPLIED FOR GMP FULL ASSESSMENT 2021-09-17Not Assessed977
8597131/2021DUO-EDGESILDENAFIL & DAPOXETINE APPLIED FOR GMP FULL ASSESSMENT 2021-09-17Not Assessed977
8607129/2021EDGENEXTRANEXAMIC ACID APPLIED FOR GMP FULL ASSESSMENT 2021-09-17Not Assessed977
8617270/2021AMVA DENK 5/160MGAMLODIPINE/ VALSARTAN NOT APPLIED RECOGNITION 2021-09-20Under Approval974
8627296/2021MINOXI 5% TOPICAL SOLUTIONMINOXIDIL NOT APPLIED FULL ASSESSMENT 2021-09-21Not Assessed973
8637334/2021AGOCOLD PLUS SYRUPPARACETAMOL/ PHENYLEPHRINE HCL/ CHLORPHENIRAMINE MALEATE/ SODIUM CITRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21Not Assessed973
8647332/2021DIX TABLETSDIGOXIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-212nd Assessment Completed 973
8657331/2021LC DOPALEVODOPA/ CARBIDOPA GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21Not Assessed973
8667328/2021AGONOR NORFLOXACIN GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-21Under Approval973
8677324/2021CETAPIRPIRACETAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21Under Approval973
8687322/2021AGOVIR-TABLETACICLOVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-09-21Under Approval973
8697548/2021XYLOCAINE GEL 2%XYLOMETAZOLINE HYDROCHLORIDE NOT APPLIED ABRIDGED 2021-09-24Peer Review970
8707547/2021ZYLORIC-200ALLOPURINOL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-24Under Approval970
8717545/2021MARCAINE SPINAL 0.5% HEAVY AMPS.BUPIVACAINE HYDROCHLORIDE NOT APPLIED ABRIDGED 2021-09-24Under Approval970
8727808/2021FENTANYLFENTANYL GMP CERTIFICATE AVAILABLE ABRIDGED 2021-09-30Under Approval964
8737844/2021NEURO-STONEPREGABALIN/ METHYLCOBALAMINE/ FOLIC ACID/ PYRIDOXINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-01Under Approval963
8747832/2021MONTEMAC-5MONTELUKAST GMP CERTIFICATE AVAILABLE RECOGNITION 2021-10-01Under Approval963
8758114/2021LEVODAY TABLETLEVOFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2021-10-08Not Assessed956
8768115/2021FLACOGYL SUSPENSIONBENZOYL METRONIDAZOLE NOT APPLIED FULL ASSESSMENT 2021-10-08Not Assessed956
8778266/2021FOXA-500CIPROFLOXACIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-12Not Assessed952
8788230/2021MEDI-KEEL A THROAT LOZENGESCETYLPYRIDINIUM CHLORIDE+BENZOCAINE APPLIED FOR GMP ABRIDGED 2021-10-12Under Approval952
8798265/2021NIFESTA-20NIFEDIPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-122nd Assessment Completed 952
8808264/2021S-TRIMTRIMETHOPRIM AND SULPHAMETHOXAZOLE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-12Not Assessed952
8818290/2021AMSUS FORTETAMSULOSIN HYDROCHLORIDE/ DUTASTERIDE NOT APPLIED FULL ASSESSMENT 2021-10-13Not Assessed951
8828291/2021COLD-CZPARACETAMOL/ PHENYLEPHRINE HCL/ CAFFEINE/ DIPHENHYDRAMINE HCL NOT APPLIED FULL ASSESSMENT 2021-10-13Not Assessed951
8838292/2021DAPOSUL-30DAPOXETINE NOT APPLIED FULL ASSESSMENT 2021-10-13Not Assessed951
8848293/2021DAPOSUL-60DAPOXETINE NOT APPLIED FULL ASSESSMENT 2021-10-13Not Assessed951
8858369/2021ARTESUNATE POWDER FOR INJARTESUNATE STERILE/ SODIUM CHLORIDE/ SODIUM BICARBONATE GMP CERTIFICATE AVAILABLE RECOGNITION 2021-10-14Peer Review950
8868631/2021GMETHINDOMETHACINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-10-21Not Assessed943
8879087/2021HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2021-11-022nd Assessment Completed 931
8889088/2021OMEPRAZOLEOMEPRAZOLE GMP CERTIFICATE AVAILABLE ABRIDGED 2021-11-02Pending 2st Assessment931
8899090/2021CLOXACILLIN SODIUM CLOXACILLIN SODIUM GMP CERTIFICATE AVAILABLE ABRIDGED 2021-11-022nd Assessment Completed 931
8909537/2021ALLERCARE MONTELUKAST SODIUM/ LEVOCETRIZINE APPLIED FOR GMP FULL ASSESSMENT 2021-11-10Not Assessed923
8919536/2021MANIGRA PLUSSILDENAFIL CITRATE/ DAPOXETINE APPLIED FOR GMP FULL ASSESSMENT 2021-11-10Not Assessed923
8929584/2021ESCORTS LEVO-72 DS TABSLEVONORGESTREL BP APPLIED FOR GMP FULL ASSESSMENT 2021-11-11Not Assessed922
89310282/2021MEDIVEN-S OINTMENTBETAMETHASONE VALEARATE BP/ SALICYLIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-11-292nd Assessment Completed 904
89410346/2021FOLIGRAF 300 I.U.FOLLITROPIN CONCENTRATED SOLUTION (RECOMBINANT) GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-11-30Not Assessed903
89510354/2021MOLNAFLUMOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-11-302nd Assessment Completed 903
89610445/2021LUMALEARTEMETHER+ LUMEFANTRINE APPLIED FOR GMP FULL ASSESSMENT 2021-12-02Not Assessed901
897TRANSICTRANEXAMIC ACID GMP CERTIFICATE AVAILABLE RECOGNITION 2021-12-08To Update Dossier895
89810714/2021CACHMAX-200CEFIXIME NOT APPLIED FULL ASSESSMENT 2021-12-08Not Assessed895
89910707/2021CACHMONT-LC SYRUPLEVOCETIRIZINE DIHYDROCHLORIDE & MONTELUKAST SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-12-08Not Assessed895
90010711/2021CACHMAX-DS SYRUPCEFIXIME NOT APPLIED FULL ASSESSMENT 2021-12-08Not Assessed895
90110712/2021EASCOF-LS SYRUPLEVOSALBUTAMOL SULPHATE/ AMBROXOL HYDROCHLORIDE/ GUAIPHENESIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-12-08Not Assessed895
90210708/2021EMITINO TABLETONDANSETRON APPLIED FOR GMP FULL ASSESSMENT 2021-12-08Pending 2st Assessment895
90310709/2021CACHMAX-400CEFIXIME NOT APPLIED FULL ASSESSMENT 2021-12-08Not Assessed895
90410710/2021EASCOF-D SYRUPDEXTROMETHORPHAN HYDROBROMIDE/ PHENYLEPHRINE HYDROCHLORIDE & CHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-12-08Not Assessed895
90510713/2021CACHMONT-LC TABLETMONTELUKAST SODIUM/ LEVOCETRIZINE DIHYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2021-12-08Not Assessed895
90610832/2021AIVCLAV-625AMOXICILLIN/ CLAVULANIC ACID APPLIED FOR GMP FULL ASSESSMENT 2021-12-10Not Assessed893
90711050/2021ITRACOS 100ITRACONAZOLE APPLIED FOR GMP FULL ASSESSMENT 2021-12-16Not Assessed887
90811052/2021DESLORATOR SPDESLORATADINE APPLIED FOR GMP FULL ASSESSMENT 2021-12-16Not Assessed887
90911053/2021MYCOBACT CREAMClotrimazole, Betamethasone Dipropionate and Neomycin cream APPLIED FOR GMP FULL ASSESSMENT 2021-12-16Not Assessed887
91011316/2021ACYCLOVIR DENK ACYCLOVIR NOT APPLIED RECOGNITION 2021-12-22Under Approval881
91111311/2021VILDA DENK 50 MG VILDAGLIPTIN NOT APPLIED ABRIDGED 2021-12-22Peer Review881
91211313/2021DICLO-DENK 50 DICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE ABRIDGED 2021-12-22Under Approval881
91311312/2021AMOXI-DENK 1000AMOXICILLIN TRIHYDRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2021-12-22Pending 1st Assessment881
914104/2022AMLOLAANLOSARTAN POTASSIUM +AMLODIPINE BESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-052nd Assessment Completed 867
915164/2022DALACIN TCLINDAMYCIN PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-06Not Assessed866
916230/2022GARDASILHUMAN PAPILLOMAVIRUS 1 TYPE 6L1 PROTEIN+HUMAN PAPILLOMAVIRUS 1 TYPE 11L1 PROTEIN+HUMAN PAPILLOMAVIRUS 1 TYPE 16L1 PROTEIN+HUMAN PAPILLOMAVIRUS 1 TYPE 18L1 PROTEIN NOT APPLIED ABRIDGED 2022-01-07To Update Dossier865
917290/2022LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE 150MG/200MG/300MGLAMIVUDINE/NEVIRAPINE/ZIDOVUDINE GMP CERTIFICATE AVAILABLE RECOGNITION 2022-01-10Under Approval862
918458/2022DEXONADEXAMETHASONE NOT APPLIED FULL ASSESSMENT 2022-01-12Not Assessed860
919459/2022TINIBA 500TINIDAZOLE NOT APPLIED FULL ASSESSMENT 2022-01-12Not Assessed860
920460/2022CADISTIN SYRUPCHLORPHENIRAMINE MALEATE USP/GUAIFENESIN USP/AMMONIUM CHLORIDE USP/SODIUM CITRATE BP/LEVOMENTHOL BP/TERPIN HYDRATE US/TOLU BALSAM USP/VASAKA SYRUP APPLIED FOR GMP FULL ASSESSMENT 2022-01-12Not Assessed860
921462/2022DEPIN E RETARDNIFEDIPINE NOT APPLIED FULL ASSESSMENT 2022-01-12Not Assessed860
922463/2022BETANASEGLIBENCLAMIDE NOT APPLIED FULL ASSESSMENT 2022-01-12Not Assessed860
923464/2022ZOSEC CAPSULESOMEPRAZOLE APPLIED FOR GMP FULL ASSESSMENT 2022-01-12Not Assessed860
924465/2022URINORMFEBUXOSTAT GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-122nd Assessment Completed 860
925466/2022PIRICAM 20PIROXICAM GMP CERTIFICATE AVAILABLE RECOGNITION 2022-01-12Peer Review860
926582/2022FLEXSA 1500 SACHETCRYSTALLINE GLUCOSAMINE SULFATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-14Pending 1st Assessment858
927672/2022CANDIZOLEFLUCONAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-17Pending 1st Assessment855
928675/2022JUNIOR CETAMOLPARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-17Pending 1st Assessment855
929723/2022ALBENDAZOLE SUSPENSIONALBENDAZOLE NOT APPLIED FULL ASSESSMENT 2022-01-18Not Assessed854
930855/2022DASATINIB NEAPOLIS-20DASATINIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-19Pending 2st Assessment, ADD.DATA853
931856/2022DASATINIB NEAPOLIS-50DASATINIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-19Pending 2st Assessment, ADD.DATA853
932857/2022DASATINIB NEAPOLIS-70DASATINIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-19Pending 2st Assessment, ADD.DATA853
933991/2022EMKIT-DSLEVONORGESTREL BP APPLIED FOR GMP FULL ASSESSMENT 2022-01-21Not Assessed851
9341065/2022AGOXIN-125 DTAMOXICILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-24Pending 1st Assessment848
9351065/2022DT-ZINCZINC SULPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-01-24Under Approval848
9361153/2022GOPAYN MRACECLOFENAC/ TIZANIDINE/ PARACETAMOL NOT APPLIED FULL ASSESSMENT 2022-01-26Not Assessed846
9371477/2022AUROMOXMOXIFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2022-02-02Not Assessed839
9381710/2022MINOXIN PLUS SOLUTION 5% APPLIED FOR GMP FULL ASSESSMENT 2022-02-07Not Assessed834
9391711/2022MINOXIN SOLUTION 2% APPLIED FOR GMP FULL ASSESSMENT 2022-02-07Not Assessed834
9402327/2022NUROKIND INJMECOBALAMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-182nd Assessment Completed 823
9412330/2022BRUTAFLAM-90ETORICOXIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-182nd Assessment Completed 823
9422329/2022BRUTAFLAM-60ETORICOXIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-182nd Assessment Completed 823
9432328/2022TOTACEF-1000 INJ.CEFEPIME HYDROCHLORIDE (STERILE) GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-18Not Assessed823
9442460/2022MELANOV-MGLICLAZIDE & METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-22Not Assessed819
9452458/2022ABLEPT-300GABAPENTINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-222nd Assessment Completed 819
9462457/2022MURAXAL-10ALFUZOSIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-222nd Assessment Completed 819
9472462/2022AMLOLAAN-H LOSARTAN POTASSIUM/ AMLODIPINE BESILATE/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-02-22Not Assessed819
9482771/2022SYBRAVA 284INCLISIRAN SODIUM NOT APPLIED RECOGNITION 2022-02-28Under Approval813
9492925/2022LINEZOLID IV INJECTIONLINEZOLID APPLIED FOR GMP FULL ASSESSMENT 2022-03-02Not Assessed811
9502926/2022PARACETAMOL INFUSION 10MG/MLPARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2022-03-02Not Assessed811
9512927/2022IRON SUCROSE INJECTION 20MG/MLIRON SUCROSE APPLIED FOR GMP FULL ASSESSMENT 2022-03-02Not Assessed811
9523358/2022COBALEDGEPREGABALIN/ MECOBALAMIN APPLIED FOR GMP FULL ASSESSMENT 2022-03-11Not Assessed802
9533365/2022BACTROSECSECNIDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-03-112nd Assessment Completed 802
9543366/2022DOXYGLOBEDOXYCYCLINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-03-11Not Assessed802
9553419/2022PEMETREXED NEAPOLIS-100 PEMETREXED GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-03-142nd Assessment Completed 799
9563420/2022PEMETREXED NEAPOLIS-500PEMETREXED GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-03-142nd Assessment Completed 799
9574423/2022PHYTON 2.25 G INJ.PIPERACILLIN/ TAZOBACTAM APPLIED FOR GMP FULL ASSESSMENT 2022-04-05Not Assessed777
9584424/2022MERIMIX 1.5G INJ.MEROPENEM/ SULBACTAM APPLIED FOR GMP FULL ASSESSMENT 2022-04-05Not Assessed777
9594425/2022PHYTON 4.5G INJ.PIPERACILLIN/ TAZOBACTAM APPLIED FOR GMP FULL ASSESSMENT 2022-04-05Not Assessed777
9604585/2022PANTAKIND-40PANTOPRAZOLE SODIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-04-08Under Approval774
9614735/2022PREGASOM-MPREGABALIN/ MECOBALAMIN NOT APPLIED FULL ASSESSMENT 2022-04-12Not Assessed770
9624833/2022DEXEM-100MCGDEXMEDETOMIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-04-13Not Assessed769
9635155/2022DICLOFENAC SODIUMDICLOFENAC SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 2022-04-21Pending 2st Assessment761
9645724/2022MOLENA 200MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-05-052nd Assessment Completed 747
9656111/2022STRIPIRAVIR-400MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-05-112nd Assessment Completed 741
9666112/2022STRIPIRAVIR-200MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-05-112nd Assessment Completed 741
9676188/2022ANOVILEC-5CILNIDIPINE APPLIED FOR GMP FULL ASSESSMENT 2022-05-12Not Assessed740
9686188/2022BNOVILEC-10CILNIDIPINE APPLIED FOR GMP FULL ASSESSMENT 2022-05-12Not Assessed740
9696188/2022CNOVILEC-20CILNIDIPINE APPLIED FOR GMP FULL ASSESSMENT 2022-05-12Not Assessed740
9706189/2022AMETAPIR-50TOPIRAMATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-05-12Under Approval740
9716671/2022OXCIN OPHTHALMIC SOLUTIONMOXIFLOXACIN HYDROCHLORIDE BP NOT APPLIED RECOGNITION 2022-05-23Under Approval729
9726672/2022OXCIN-D OPHTHALMIC SOLUTIONMOXIFLOXACIN HYDROCHLORIDE BP /DEXAMETHASONE PHOSPHATE NOT APPLIED RECOGNITION 2022-05-23Under Approval729
9736674/2022ASCARD-75 TABLETSACETYLSALICYLIC ACID NOT APPLIED RECOGNITION 2022-05-23Pending 1st Assessment729
9747280/2022MISOPT EYE DROPSDORZOLAMIDE HYDROCHLORIDE/TIMOLOL MALEATE APPLIED FOR GMP FULL ASSESSMENT 2022-05-27Not Assessed725
9757602/2022CISATREX 2MG/MLCISATRACURIUM BESILATE APPLIED FOR GMP FULL ASSESSMENT 2022-05-30Not Assessed722
9767997/2022PRINORELAX 30MGCYCLOPENTOLATE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-032nd Assessment Completed 718
9777998/2022DAPAVELDACTIN 10MGDAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Under Approval718
9787999/2022ATROZEMB 10-10MGATORVASTATIN/EZETIMIBE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9798000/2022GLYBOFEN 5/1000MGGLYBURIDE/METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9808001/2022WELLNESSPARACETAMOL/PSEUDOEPHEDRINE HYDROCHLORIDE/DEXTROMETHORPHAN HYDROBROMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9818002/2022DAPAVELDACTIN PLUS 5/850MG DAPAGLIFLOZIN/METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9828003/2022PRINORELAX 15CYLOBENZAPINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-032nd Assessment Completed 718
9838004/2022VAXATO 15MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Under Approval718
9848005/2022ATROZEMB 20-10MGATORVASTATIN/EZETIMIBE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9858006/2022VAXATO 20MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Under Approval718
9868007/2022VAXATO 10MGRIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Under Approval718
9878008/2022DAPAVELDACTIN 5MGDAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Under Approval718
9888009/2022DAPAVELDACTIN PLUS 5/1000MG DAPAGLIFLOZIN/METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-03Not Assessed718
9898440/2022AMLOSUN LS(-) AMLODIPINE/LOSARTAN POTASSIUM NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9908441/2022EBASTANEBASTINE NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9918442/2022QUITULSAAMOXICILLIN USP/CLARITHROMYCIN USP/ESOMEPRAZOLE NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9928443/2022VOMISUN MDONDANSETRON NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9938444/2022VOMISUN SYRUPONDANSETRON NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9948445/2022AMLOSUN DS(-) AMLODIPINE/LOSARTAN POTASSIUM NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9958446/2022EBASTAN ORAL SOLUTIONEBASTINE NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9968447/2022LASPACOLDROTAVERINE HYDROCHLORIDE/PARACETAMOL BP NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9978448/2022VAGIDIS KITFLUCONAZOLE USP/AZITHROMYCIN USP/SECNIDAZOLE NOT APPLIED FULL ASSESSMENT 2022-06-13Not Assessed708
9988568/2022ROLINOZ ORAL DROPSCETIRIZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14Peer Review707
9998569/2022VANKO-WMVANCOMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14Not Assessed707
10008570/2022ZIROMINAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-142nd Assessment Completed 707
10018566/2022TENECTASETENECTASE APPLIED FOR GMP FULL ASSESSMENT 2022-06-14Not Assessed707
10028567/2022UNSIATEMFEBUXOSTAT GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14Not Assessed707
10038571/2022SERTOFENDEXKETOPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14Not Assessed707
10048572/2022ZIROMIN POWDER FOR ORAL SUSPENSIONAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-142nd Assessment Completed 707
10058573/2022ROLINOZ TABLETSCETIRIZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-14Pending 2st Assessment707
10069092/2022EMICOSONDANSETRON APPLIED FOR GMP FULL ASSESSMENT 2022-06-24Not Assessed697
10079093/2022DALAMYCIN TOPICAL LOTION CLINDAMYCIN PHOSPHATE APPLIED FOR GMP FULL ASSESSMENT 2022-06-24Not Assessed697
10089095/2022LEVOCOSLEVOFLOXACIN APPLIED FOR GMP FULL ASSESSMENT 2022-06-24Not Assessed697
10099235/2022NEUROMED 75MGPREGABALINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-282nd Assessment Completed 693
10109236/2022ATOR 10ATORVASTATIN CALCIUM TRIHYDRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-28Pending 1st Assessment693
10119237/2022ATOR 20ATORVASTATIN CALCIUM TRIHYDRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-06-28Pending 1st Assessment693
101210333/2022NEOTAGMINNEOSTIGMINE METHYLSULFATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-07-202nd Assessment Completed 671
101311204/2022LASTAVIN AM 5/160AMLODIPINE AND VALSARTAN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-082nd Assessment Completed 652
101411208/2022LASTAVIN HTZ 160/12.5VALSARTAN AND HYDROCHLOROTHIAZIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-08Not Assessed652
101511207/2022LASTAVIN AM 10/160AMLODIPINE AND VALSARTAN USP GMP CERTIFICATE AVAILABLE RECOGNITION 2022-08-08Under Approval652
101611206/2022LASTAVIN HTZ 80/12.5VALSARTAN AND HYDROCHLOROTHIAZIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-08Not Assessed652
101711210/2022LASTAVIN 80VALSARTAN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-08Peer Review652
101811229/2022PANTO 40PANTOPRAZOLE USP NOT APPLIED FULL ASSESSMENT 2022-08-09Not Assessed651
101911230/2022PANTO 20PANTOPRAZOLE SODIUM NOT APPLIED FULL ASSESSMENT 2022-08-09Not Assessed651
102011618/2022NEW-FLOTANHALOTHANE NOT APPLIED FULL ASSESSMENT 2022-08-17Not Assessed643
102111875/2022LOSARTAN POTASSIUM TABLETS USP 50 MGLOSARTAN POTASSIUM USP APPLIED FOR GMP FULL ASSESSMENT 2022-08-22Not Assessed638
102211876/2022CAVE-12.5 MGCARVEDILOL USP APPLIED FOR GMP FULL ASSESSMENT 2022-08-22Not Assessed638
102311877/2022FAZOL-150FLUCONAZOLE BP APPLIED FOR GMP FULL ASSESSMENT 2022-08-22Not Assessed638
102411878/2022CAVE-6.25CARVEDILOL USP APPLIED FOR GMP FULL ASSESSMENT 2022-08-22Not Assessed638
102511879/2022LOVON-100SILDENAFIL CITRATE USP APPLIED FOR GMP FULL ASSESSMENT 2022-08-22Not Assessed638
102611940/2022SOLIVO 20LEFLUNOMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-23Pending 2st Assessment637
102711939/2022SOLIVO 10LEFLUNOMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-08-23Pending 2st Assessment637
102812008/2022OXALEN-10METHOXSALEN USP APPLIED FOR GMP FULL ASSESSMENT 2022-08-24Not Assessed636
102912091/2022LEVONEX HP KIT TABLETSESOMEPRAZOLE, LEVOFLOXACIN, AMOXICILLIN NOT APPLIED FULL ASSESSMENT 2022-08-26Not Assessed634
103012245/2022ALBENDAZOLE 400MG CHEWABLE TABLETSALBENDAZOLE APPLIED FOR GMP RECOGNITION 2022-08-29Under Approval631
103112752/2022BACTICLOX CAPSULES AMPICILLIN TRIHYDRATE BP/CLOXACILLIN SODIUM BP APPLIED FOR GMP FULL ASSESSMENT 2022-09-05Not Assessed624
103212753/2022AZEESCOT-500AZITHROMYCIN USP APPLIED FOR GMP FULL ASSESSMENT 2022-09-05Not Assessed624
1033RWANDA-FDA23/HM/0172MomadermMometasone Furoate Cream USP 0.1% w/w GMP AVAILABLE RECOGNITION 2022-09-06Under Approval623
103412958/2022AATRACURIUM 5MLATRACURIUM BESYLATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-072nd Assessment Completed 622
103512958/2022BATRACURIUM 2.5MLATRACURIUM BESYLATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-072nd Assessment Completed 622
103612959/2022ACISATRA 5MLCISATRACURIUM BESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-072nd Assessment Completed 622
103712959/2022BCISATRA 10MLCISATRACURIUM BESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-07Not Assessed622
103813031/2022RIFAPENTINE TABLETS 300MGRIFAPENTINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-08Pending 1st Assessment621
103913034/2022COLDAMOL CAPSULESPARACETAMOL BP/PSEUDOEPHRINE HCL/CHLORPHENIRAMINE MALEATE BP/CAFFEINE ANHYDROUS BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-09Not Assessed620
104013035/2022SARTILOSLOSARTAN POTASSIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-092nd Assessment Completed 620
104113142/2022CYCLOPHOSPHAMIDE SANDOZ 1000MGCYCLOPHOSPHAMIDE MONOHYDRATE NOT APPLIED FULL ASSESSMENT 2022-09-09Not Assessed620
104213144/2022CYCLOPHOSPHAMIDE SANDOZ 500MGCYCLOPHOSPHAMIDE MONOHYDRATE NOT APPLIED FULL ASSESSMENT 2022-09-09Not Assessed620
104313775/2022ESLOTIN 2.5MG/ML SYRUPDESLORATADINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-21Under Approval608
104413776/2022INSUFOR 850MG METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-212nd Assessment Completed 608
104513777/2022SERTOFEN 25MGDEXKETOPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-212nd Assessment Completed 608
104613854/2022INSUFOR 500MG METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-212nd Assessment Completed 608
104713947/2022MP 40METHYLPREDNISOLONE HYDROGEN SUCCINATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-232nd Assessment Completed 606
104813948/2022VIADIS 100MGSILDENAFIL CITRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-23Pending 2st Assessment606
104913949/2022MEXINE 200MGCIMETIDINE GMP CERTIFICATE AVAILABLE ABRIDGED 2022-09-23Pending 2st Assessment606
105013950/2022CO-LOSAR 50MG/12.5MGLOSARTAN/HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-23Pending 1st Assessment606
105113951/2022LEVOFLOX 5MG/ML LEVOFLOXACIN HEMIHYDRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-232nd Assessment Completed 606
105213952/2022ZITRO 500AZITHROMYCIN DIHYDRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-23Not Assessed606
105314059/2022MONOSOPT EYE DROPSDORZOLAMIDE HYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2022-09-26Not Assessed603
105414060/2022TOLSIN 0.4TAMSULOSIN HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-26Not Assessed603
105514062/2022MASRONE 2MGRISPERIDONE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-09-262nd Assessment Completed 603
1056RWANDA-FDA23/HM/0206Dawa-CPM TabletsCHLORPHENAMINE MALEATE ABBRIDGED 2022-10-04Not Assessed595
105714760/2022LASTAVIN AM PLUS 5/160/25AMLODIPINE/ VALSARTAN/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-062nd Assessment Completed 593
105814761/2022LASTAVIN AM PLUS 10/160/12.5AMLODIPINE/ VALSARTAN/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-06Not Assessed593
105914762/2022VILDARIL M 50/1000VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-06Queried_Assessment-Round1593
106014763/2022VILDARIL M 50/850VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-06Queried_Assessment-Round1593
106114765/2022VILDARIL M 50/500VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-06Queried_Assessment-Round1593
106215063/2022DEXAMETHASONE MEDISDEXAMETHASONE PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-11Under Approval588
106315065/2022APMALT SYRUPIRON (III) HYDROXIDE POLYMALTOSE APPLIED FOR GMP FULL ASSESSMENT 2022-10-12Not Assessed587
106415191/2022METROPEN SUSPENSIONMETRONIDAZOLE BENZOATE APPLIED FOR GMP FULL ASSESSMENT 2022-10-13Not Assessed586
106515190/2022RENECHLOR SUSPENSIONCHLORAMPHENICOL PALMITATE NOT APPLIED FULL ASSESSMENT 2022-10-13Not Assessed586
106615439/2022TROGYL PLUS TABLETMETRONIDAZOLE/ DILOXANIDE FUROATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-18Not Assessed581
106715440/2022RAYZIUM 20ESOMEPRAZOLE MAGNESIUM TRIHYDRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2022-10-18Under Approval581
106815445/2022TROGYL PLUS SUSPENSIONMETRONIDAZOLE/ DILOXANIDE FUROATE GMP CERTIFICATE AVAILABLE ABRIDGED 2022-10-18Under Approval581
1069RWANDA-FDA23/HM/0060MOCINMoxifloxacin FULL ASSESSMENT 2022-10-19Not Assessed580
107015576/2022EMPADIL 25EMPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-202nd Assessment Completed 579
107115575/2022EMPADIL 10EMPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-202nd Assessment Completed 579
107215681/2022CHLORAMPHENICOL 250CHLORAMPHENICOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Pending 2st Assessment578
107315682/2022METRONIDAZOLE 250METRONIDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
107415683/2022FINI-GAS SUSPENSION 15ML POUCHALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONE & OXETHAZAINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
107515684/2022METFUR 850METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
107615685/2022FINI-COUGH 30MG/5MLAMBROXOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
107715686/2022IBUPROFEN 200IBUPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
107815687/2022CONSTIGOLACTULOSE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
107915688/2022IBUPROFENIBUPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108015689/2022FINI-MAL 20/120ARTEMETHER/ LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108115690/2022SEAGRASILDENAFIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
108215693/2022CIPROFLOXACIN 500CIPROFLOXACIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
108315694/2022GASTRO-RESISTANT DICLOFENAC 50DICLOFENAC GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
108415695/2022PARACETAMOL 500PARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108515696/2022ERYTHROMYCINERYTHROMYCIN STEARATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
108615697/2022METFUR 1000METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108715698/2022PARACETAMOL ORAL SUSPENSIONPARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108815699/2022FINI-COUGH 15MG/5MLAMBROXOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
108915700/2022FINI-MAL 80/480ARTEMETHER& LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
109015701/2022ALBENDAZOLEALBENDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
109115702/2022GASTRO-RESISTANT DICLOFENAC 100DICLOFENAC GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
109215703/2022METFUR 500METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
109315704/2022FINI-GAS 200ML BOTTLE SUSPENSIONALUMINIUM HYDROXIDE/ MAGNESIUM HYDROXIDE/ SIMETHICONE & OXETHAZAINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
109415705/2022AZITHROMYCINAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-212nd Assessment Completed 578
109515706/2022CYTOSUNMISOPROSTOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Pending 1st Assessment578
109615707/2022IBUPROFEN& PARACETAMOL SUSPIBUPROFEN/ PARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Not Assessed578
109715713/2022SEAGRA ORAL JELLYCOMBIPACK OF SILDENAFIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-21Pending 2st Assessment578
109815791-2022IVERMECTIN IVERMECTIN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-242nd Assessment Completed 575
109915835-2022COMBIPLEX VITAMIN B1 + VITAMIN B2 + VITAMIN B6 + NICOTINAMIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-25Not Assessed574
110015836-2022LABDIC RELIEF DICLOFENAC SODIUM + PARACETAMOL + MAGNESIUM TRISILICATE + CHLORPHENAMINE MALEATE APPLIED FOR GMP FULL ASSESSMENT 2022-10-25Not Assessed574
110115837-2022SUPRIDOL TRAMADOL HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-25Not Assessed574
110215838-2022 D-NoneETHAMSYLATE NOT APPLIED FULL ASSESSMENT 2022-10-25Not Assessed574
110315839-2022TENA-50ATENOLOL BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-25Not Assessed574
110415840-2022FENTFENTANYL CITRATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-25Not Assessed574
110515841-2022MEDIPHENICOL CHLORAMPHENICOL BP + PHENYLMERCURIC NITRATE BP APPLIED FOR GMP FULL ASSESSMENT 2022-10-25Not Assessed574
110615842-2022LABDIC RELIEF DICLOFENAC SODIUM + PARACETAMOL + MAGNESIUM TRISILICATE + CHLORPHENAMINE MALEATE APPLIED FOR GMP FULL ASSESSMENT 2022-10-25Not Assessed574
110715844-2022NYSTATIN 100000 IU SUSPENSION BUVABLE NYSTATIN BP NOT APPLIED FULL ASSESSMENT 2022-10-25Not Assessed574
110815845-2022LIDOC 2%LIDOCAINE HYDROCHLORIDE BP + METHYLPARABEN BP NOT APPLIED FULL ASSESSMENT 2022-10-25Not Assessed574
1109RWANDA-FDA23/HM/0122OLODINEOlopatadine Hydrochloride FULL ASSESSMENT 2022-10-27Not Assessed572
1110RWANDA-FDA23/HM/0123ABMIST FULL ASSESSMENT 2022-10-27Not Assessed572
1111RWANDA-FDA23/HM/0042OPTORKETOROLAC TROMETHAMINE FULL ASSESSMENT 2022-10-27Not Assessed572
111216174-2022METRONIDAZOLEMETRONIDAZOLE BENZOATE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Peer Review568
111316175-2022CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Peer Review568
111416176-2022CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Peer Review568
111516177-2022CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Pending 2st Assessment568
111616178-2022ICON-100 SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Pending 2st Assessment568
111716166/2022LASTAVIN AM PLUS 10/160/25AMLODIPINE/ VALSARTAN/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Not Assessed568
111816177/2022CO-TRIMOXAZOLE SULFAMETHOXAZOLE/ TRIMETHOPRIM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Not Assessed568
111916178/2022ITRACONAZOLE 100MG ITRACONAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-10-31Not Assessed568
112016276-2022ATAZANAVIR& RITONAVIRATAZANAVIR SULFATE + RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-012nd Assessment Completed 567
112116728-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-092nd Assessment Completed 559
112216729-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-092nd Assessment Completed 559
112316730-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-092nd Assessment Completed 559
112416819-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-102nd Assessment Completed 558
112516901-2022LIDOCAINE LIDOCAINE HCL BP + BENZYL ALCOHOL APPLIED FOR GMP FULL ASSESSMENT 2022-11-11Not Assessed557
112616902-2022PARACETAMOL PARACETAMOL APPLIED FOR GMP ABRIDGED 2022-11-11Under Approval557
112716903-2022 HELBEN ALBENDAZOLE USP APPLIED FOR GMP FULL ASSESSMENT 2022-11-11Not Assessed557
112817102-2022EMITOSS-4ONDANSETRON APPLIED FOR GMP ABRIDGED 2022-11-15Under Approval553
112917103-2022EMITOSS-8ONDANSETRON NOT APPLIED ABRIDGED 2022-11-15Pending 2st Assessment553
113017205-2022ABLOL-5TIMOLOL MELEATE BP + BENZALKONIUM CHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-16Pending 2st Assessment552
113117207-2022CIPROCIN CIPROFLOXACIN HCL USP + BENZALKONIUM HCL B.P GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-16Pending 2st Assessment552
113217213-2022EMI-STONEONDANSETRON USP APPLIED FOR GMP FULL ASSESSMENT 2022-11-16Not Assessed552
113317214-2022DUTA-STONE TTAMSULOSIN HYDROCHLORIDE (MR) DUTASTERIDE APPLIED FOR GMP FULL ASSESSMENT 2022-11-16Not Assessed552
113417215-2022PHENOXYMETHYL PENICILLIN PHENOXYMETHYLPENICILLIN POTASSIUM BP APPLIED FOR GMP FULL ASSESSMENT 2022-11-16Not Assessed552
113517458-2022EMPADIL-M 5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-222nd Assessment Completed 546
113617459-2022EMPADIL-M 12.5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-222nd Assessment Completed 546
113717460-2022EMPADIL-M 5/500EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-222nd Assessment Completed 546
113817462-2022EMPADIL-M 12.5/500 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-222nd Assessment Completed 546
113917463-2022APMALT IRON (III) HYDROXIDE POLYMALTOSE COMPLEX APPLIED FOR GMP FULL ASSESSMENT 2022-11-22Not Assessed546
114017464-2022FIZZDOL-500PARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2022-11-22Not Assessed546
114117465-2022IMMUFIT-C VITAMIN-C APPLIED FOR GMP FULL ASSESSMENT 2022-11-22Not Assessed546
114217532-2022VIVIAN MR CHLORZOXAZONE + DICLOFENAC SODIUM + PARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-22Pending 2st Assessment, ADD.DATA546
114317533-2022TOFLOX-OZ OFLOXACIN + ORNIDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-22Not Assessed546
114417771-2022IMATINIB NEAPOLIS IMATINIB MESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-252nd Assessment Completed 543
114517772-2022DECETAXEL NEAPOLIS DOCETAXEL ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-252nd Assessment Completed 543
114617773-2022IMATINIB NEAPOLIS IMATINIB MESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-252nd Assessment Completed 543
114717774-2022DECETAXEL NEAPOLIS DOCETAXEL ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-252nd Assessment Completed 543
114817775-2022CAPECITABINE NEAPOLISCAPECITABINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-25Pending 2st Assessment, ADD.DATA543
114917974-2022LETROZOLE NEAPOLISLETROZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-11-302nd Assessment Completed 538
115018031-2022COLOPREP SODIUM SUFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE NOT APPLIED FULL ASSESSMENT 2022-12-01Not Assessed537
115118085-2022ALVEOFACT RECOMBINANT-SF-RI NOT APPLIED RECOGNITION 2022-12-02Under Approval536
115218086-2022ALVEOFACT RECOMBINANT-SF-RI NOT APPLIED RECOGNITION 2022-12-02Under Approval536
115318274-2022PIRETIKOL PLUS PARACETAMOL + CHLORPHENIRAMINE + PHENYLEPHRINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-06Not Assessed532
115418273-2022HELMADOL 400MG FCT ALBENDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-062nd Assessment Completed 532
115518418-2022ULGICID ALGINIC ACID BP, DRIED ALUMINIUM HYDROXIDE BP, MAGNESIUM TRISILICATE BP, ACTIVATED DIMETHICONE BP NOT APPLIED FULL ASSESSMENT 2022-12-09Not Assessed529
115618611-2022PARACETAMOL PARACETAMOL APPLIED FOR GMP FULL ASSESSMENT 2022-12-13Not Assessed525
115719368/2022CEFTAZIDIME FOR INJECTION USP 1GCEFTAZIDIME GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-29Not Assessed509
115819413/2022ANASTROZOLE NEAPOLISANASTROZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-30Peer Review508
115919414/2022FLUDARABINE PHOSPHATE NEAPOLISFLUDARABINE PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-30Not Assessed508
116019415/2022GEMCITABINE NEAPOLISGEMCITABINE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2022-12-30Not Assessed508
11610159/2023HAEMOFORTE SYRUPIRON PLUS VITAMINS NOT APPLIED FULL ASSESSMENT 2023-01-06Not Assessed501
11620181/2023BIOFULVINGRISEOFULVIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-01-06Under Approval501
11630184/2023EMSYN-10EMPAGLIFLOZIN APPLIED FOR GMP FULL ASSESSMENT 2023-01-06Not Assessed501
11640185/2023XAROBAN-15RIVAROXABAN APPLIED FOR GMP FULL ASSESSMENT 2023-01-06Not Assessed501
11650186/2023XAROBAN-20RIVAROXABAN APPLIED FOR GMP FULL ASSESSMENT 2023-01-06Not Assessed501
11660187/2023EMSYN-25EMPAGLIFLOZIN APPLIED FOR GMP FULL ASSESSMENT 2023-01-06Not Assessed501
11670342/2023CEFEX-25CEFALEXIN APPLIED FOR GMP FULL ASSESSMENT 2023-01-10Not Assessed497
1168BICALUTAMIDE INTAS 50BICALUTAMIDE GMP CERTIFICATE AVAILABLE RECOGNITION 2023-01-18To Update Dossier489
11691090/2023ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE TABLETS FOR ORAL SUSPENSIONABACAVIR, DOLUTEGRAVIR, LAMIVUDINE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-01-25Not Assessed482
11701493/2023WELGRA 100SILDENAFIL CITRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-03Pending 1st Assessment473
11711715/2023DYDROGLAXDYDROGESTERONE APPLIED FOR GMP FULL ASSESSMENT 2023-02-08Not Assessed468
11721716/2023LORTANLOSARTAN POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2023-02-08Not Assessed468
11731717/2023VAGIDUOCLINDAMYCIN POTASSIUM& CLOTRIMAZOLE APPLIED FOR GMP FULL ASSESSMENT 2023-02-08Not Assessed468
11741718/2023LORTAN-HLOSARTAN POTASSIUM& HYDROCHLOROTHIAZIDE APPLIED FOR GMP FULL ASSESSMENT 2023-02-08Not Assessed468
11751993/2023COLDAMOL-P SYRUPCHLORPHENIRAMINE MALEATE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-02-13Under Approval463
11761994/2023HYOSPAN SYRUPHYOSCINE BUTYL BROMIDE BP GMP CERTIFICATE AVAILABLE ABRIDGED 2023-02-13Under Approval463
11772072/2023MICROPRIDE-25LEVOSULPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-14Peer Review462
11782073/2023EROSTIN-20EBASTINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-14Pending 2st Assessment462
11792077/2023PANTOTAB-LPANTOPRAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-142nd Assessment Completed 462
11802288/2023DASATINIB NEAPOLIS 140DASATINIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-17Pending 2st Assessment, ADD.DATA459
11812632/2023XIPRO-500CIPROFLOXACIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Pending 2st Assessment452
11822624/2023COMIT-100 SILDENAFIL CITRATE BP NOT APPLIED FULL ASSESSMENT 2023-02-24Not Assessed452
11832627/2023ANTOPRAZPANTOPRAZOLE SODIUM APPLIED FOR GMP FULL ASSESSMENT 2023-02-24Not Assessed452
11842620/2023MELANEZ 500MESALAZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Not Assessed452
11852622/2023FELVIN-20PIROXICAM BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Pending 1st Assessment452
11862629/2023UPRONE-40OMEPRAZOLE APPLIED FOR GMP FULL ASSESSMENT 2023-02-24Not Assessed452
11872631/2023P ALAXIN DS 80/640DIHYDROARTEMISININ/ PIPERAQUIN PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Pending 1st Assessment452
11882625/2023P-ALAXIN DS 20/160DIHYDROARTEMISININ/ PIPERAQUIN PHOSPHATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Pending 2st Assessment452
11892621/2023XEBISCO 150PREGABALIN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-242nd Assessment Completed 452
11902633/2023XEBISCO 75PREGABALIN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-02-24Pending 1st Assessment452
11912851/2023BONEY VITCHEWABLE CALCIUM SUPPLEMENT WITH MAGNESIUM, ZINC AND VITAMIN D3 GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
11922856/2023CACHDERM-NBECLOMETHASONE, NEOMYCIN SULPHATE & CLOTRIMAZOLE APPLIED FOR GMP FULL ASSESSMENT 2023-03-01Not Assessed447
11932852/2023MALPHOSMOMETASONE FUROATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Pending 1st Assessment447
11942853/2023TAMREL-DTAMSULOSIN HYDROCHLORIDE, DUTASTERIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
11952854/2023SILVACACHSILVER SULFADIAZINE & CHLORHEDINE GLUCONATE APPLIED FOR GMP FULL ASSESSMENT 2023-03-01Not Assessed447
11962855/2023CACHDERM-GBECLOMETHASONE DIPROPRIONATE, CLOTRIMAZOLE & GENTAMICIN SULPHATE APPLIED FOR GMP FULL ASSESSMENT 2023-03-01Not Assessed447
11972858/2023CACHFIX NASAL SPRAYFLUTICASONE FUROATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
11982859/2023CACHGUARDLULICONAZOLE APPLIED FOR GMP FULL ASSESSMENT 2023-03-01Not Assessed447
11992860/2023CACHET\'S SALINE NASAL SPRAYSODIUM CHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12002861/2023VITAFER FORTEIRON & FOLIC ACID WITH VITAMIN B12 GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12012862/2023INSTABACTMUPIROCIN APPLIED FOR GMP FULL ASSESSMENT 2023-03-01Not Assessed447
12022863/2023ZYCOTOR-10ATORVASTATIN CALCIUM NOT APPLIED FULL ASSESSMENT 2023-03-01Not Assessed447
12032864/2023ZYCOTOR-20ATORVASTATIN CALCIUM NOT APPLIED FULL ASSESSMENT 2023-03-01Not Assessed447
12042865/2023ES-OMECOSESOMEPRAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12052866/2023HELICOS KITAMOXICILLIN/ CLARITHROMYCIN/ LANSOPRAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12062873/2023APIGESIC PLUSACECLOFENAC/ PARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12072872/2023GLYSIT PLUS 10/50DAPAGLIFLOZIN/ SITAPRIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12082871/2023GLUCOWELL MET 50/850VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12092875/2023APIGESIC FORTEACECLOFENAC, CHLORZOXAZONE & PARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12102869/2023GLUCOWELL MET 50/500VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12112868/2023CALMEX 0.5ALPRAZOLAM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12122867/2023GLYSIT 10DAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12132881/2023HARTEZE 20RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12142882/2023DABORAL 250AMINOSIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12152877/2023HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12162878/2023GLUCOWELL 50VILDAGLIPTIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12172879/2023GLYSIT 5DAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12182880/2023NYCOSTAT 100,000NYSTATIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12192889/2023DABORAL SYRUPAMINOSIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12202888/2023CLARICOS 500CLARITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Pending 1st Assessment447
12212887/2023CARDITAN AMLOSARTAN POTASSIUM/ AMLODIPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Not Assessed447
12222886/2023HARTEZE 15RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12232885/2023HARTEZE 10RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-012nd Assessment Completed 447
12242884/2023DICARD 50SACUBITRIL, VALSARTAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Pending 2st Assessment447
12252883/2023DICARD 100SACUBITRIL, VALSARTAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-01Pending 2st Assessment447
12263027/2023EMTRICITABINE/ TENOFOVIR ALFENAMIDEEMTRICITABINE/ TENOFOVIR ALFENAMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-032nd Assessment Completed 445
12273025/2023FLUCYTOSINE 500FLUCYTOSINE APPLIED FOR GMP FULL ASSESSMENT 2023-03-03Not Assessed445
12283032/2023G-OUT PLUSCOLCHINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-03Pending 2st Assessment445
12293028/2023RIFAPENTINERIFAPENTINE GMP CERTIFICATE AVAILABLE ABRIDGED 2023-03-03Under Approval445
12303368/2023ACIMOX 625AMOXICILLIN& POTASSIUM CLAVULANATE APPLIED FOR GMP FULL ASSESSMENT 2023-03-03Not Assessed445
12313371/2023ACIMOX DRY SYRUP 156.25MG/5MLAMOXICILLIN & CLAVULANATE POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2023-03-10Not Assessed438
12323370/2023ACIMOX DRY SYRUP 228.5MG/5MLAMOXICILLIN & CLAVULANATE POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2023-03-10Not Assessed438
12333369/2023ACIMOX 1.2 INJAMOXICILLIN & CLAVULANATE POTASSIUM APPLIED FOR GMP FULL ASSESSMENT 2023-03-10Not Assessed438
12343541/2023VIRALEXINOSINE PRANOBEX GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-13Pending 2st Assessment435
12353770/2023OSMOWINLACTULOSE APPLIED FOR GMP FULL ASSESSMENT 2023-03-17Under Approval431
12363771/2023SIMBRINZA BRINZOLAMIDE/ BRIMONIDINE TATRATE GMP CERTIFICATE AVAILABLE RECOGNITION 2023-03-17Under Approval431
12373909/2023GLUCOWELL 50/1000Vildagliptin & Metformin Hydrochloride GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-20Not Assessed428
12383907/2023ZINCOS DISPERSIBLE TABLETSZinc Sulfate Monohydrate GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-20Not Assessed428
12393905/2023DTS-Z KIT SODIUM CHLORIDE BP, POTASSIUM CHLORIDE BP,TRISODIUM CITRATE BP, ANHYDROUS GLUCOSE + ZINC SULFATE MONOHYDRATE. GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-03-20Not Assessed428
12404160/2023VERKETKETAMINEHYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2023-03-23Not Assessed425
12414159/2023VERZEPAMDIAZEPAM APPLIED FOR GMP FULL ASSESSMENT 2023-03-23Not Assessed425
12424155/2023BUPIVER- HBUPIVACINE HYDROCHLORIDE APPLIED FOR GMP FULL ASSESSMENT 2023-03-23Not Assessed425
12434531/2023BRINZOX TBrinzolamide USP, Timolol Maleate BP GMP CERTIFICATE AVAILABLE RECOGNITION 2023-03-31Under Approval417
1244RWANDA-FDA23/HM/0348Clotrine Pessary 200mgCLOTRIMAZOLE BP GMP AVAILABLE ABBRIDGED 2023-04-03Not Assessed414
12454825/2023ENEREXO DNSSODIUM CHLORIDE & GLUCOSE INTRAVENOUS INFUSION NOT APPLIED FULL ASSESSMENT 2023-04-06Not Assessed411
12464824/2023ENEREXO 5Glucose Intravenous Infusion BP NOT APPLIED FULL ASSESSMENT 2023-04-06Not Assessed411
12474823/2023DEEP HEAT SPRAYMethyl salicylate, ethyl salicylate, 2-hydroxyethylsalicylate and methyl nicotinate GMP CERTIFICATE AVAILABLE ABRIDGED 2023-04-06Under Approval411
1248RWANDA-FDA23/HM/0406MABTHERA IV 500MG/50MLRituximab FULL ASSESSMENT 2023-04-08Not Assessed409
12495004/2023Insulin Glargine Impact Insulin Glargine NOT APPLIED ABRIDGED 2023-04-12Under Approval405
12505044/2023KRYXANARIBOCICLIB NOT APPLIED RECOGNITION 2023-04-13Under Approval404
12515041/2023ULTRAFLOXCIPROFLOXACIN NOT APPLIED RECOGNITION 2023-04-13Under Approval404
12526924/2023RABEFLUX-DSRRAERPRAZOLE SODIUM & DOMPERIDONE APPLIED FOR GMP FULL ASSESSMENT 2023-04-13Not Assessed404
12536921//2023STEDNAC GELACECLOFENAC, LINSEED OIL, METHYL SALICYLATE, MENTHOL APPLIED FOR GMP FULL ASSESSMENT 2023-04-13Not Assessed404
12546917/2023JUSDEE 400 DROPS COLECALCIFEROL BP APPLIED FOR GMP FULL ASSESSMENT 2023-04-13Not Assessed404
12556918/2023JUSDEE 60K GRANULES COLECALCIFEROL BP APPLIED FOR GMP FULL ASSESSMENT 2023-04-13Not Assessed404
12566920/2023STEDNAC TABLET ACECLOFENAC BP APPLIED FOR GMP FULL ASSESSMENT 2023-04-13Not Assessed404
12575212/2023Z-COT 20Rivaroxaban EP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-172nd Assessment Completed 400
12585208/2023Z-COT 15Rivaroxaban EP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-17Not Assessed400
12595213/2023Colinil Drops Simethicone USP, Dill Oil BP and Fennel Oil GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-17Not Assessed400
12605214/2023MAXMOISTSodium Hyaluronate and Dexpanthenol Ophthalmic Solution GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-17Not Assessed400
12615210/2023Z-COT 10Rivaroxaban Tablets BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-17Not Assessed400
12625211/2023Ocugold PlusLutein, Zeaxanthin, Meso Zeaxanthin, Lycopene, Astaxanthin and Cholecalciferol Tablets NOT APPLIED FULL ASSESSMENT 2023-04-17Not Assessed400
12635209/2023Macugold Plus Lutein, Zeaxanthin, Astaxanthin, Acetylcysteine and Melatonin Tablets NOT APPLIED FULL ASSESSMENT 2023-04-17Not Assessed400
1264RWANDA-FDA23/HM/0176MABTHERA IV 100MG/10MLRituximab FULL ASSESSMENT 2023-04-18Not Assessed399
12655751/2023Morphine MedisMorphine Hydrochloride GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-04-27Under Approval390
12666325/2023ANTI D TRINBELIMAB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-05-022nd Assessment Completed 385
12676324/2023FOLIGRAF 450 I.UFOLLITROPIN CONCENTRATED SOLUTION (RECOMBINANT) GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 2023-05-02Not Assessed385
1268RWANDA-FDA23/HM/0076APRETUDECABOTEGRAVIR NOT APPLIED RECOGNITION 2023-05-15Under Approval372
1269RWANDA-FDA23/HM/0135NADolutegravir, Lamivudine and Tenofovir Alafenamide Tablets 50 mg/300 mg/25 mg FULL ASSESSMENT 2023-05-19Not Assessed368
1270RWANDA-FDA23/HM/0107NARifampin, Isoniazid and Pyrazinamide Dispersible Tablets 75mg, 50mg & 150mg RECOGNITION 2023-05-19Not Assessed368