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MA- Monitoring-Expired

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No. Reference No. Brand Name Generic Name GMP Status Assessment Pathway Reception Date Date 1st Assessment Date 2nd Assessment Date Query Sent Time monitor
12567/2019 CIS-CURON INJECTION CIS-ATRACURIUM BESYLATE INJECTION USP APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2024-03-152024-04-172024-05-174
2869/2019 FEMPROLETROZOLE NOT APPLIED RECOGNITION 0000-00-00
Application date
2020-04-222020-11-132024-05-174
32458/2022ABLEPT-300GABAPENTINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-11-032024-03-142024-05-0417
42238/2019ADIONE DOXYLAMINE SUCCINATE&PYRIDOXINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2021-06-222021-06-252024-04-3021
5Via EmailAGOBUTOL-4 SALBUTAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-272024-04-112024-05-0417
6Via EmailAGOPINE-SR TABLET NIFEDIPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-032024-04-092024-05-0417
7Via EmailAGOPURINOL-100ALLOPURINOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-272024-03-272024-05-0417
8Via EmailAGOPURINOL-300ALLOPURINOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-282024-04-022024-05-0417
90327/2019AMATRIX-850METFORMIN APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-11-152023-12-042024-05-174
10104/2022AMLOLAANLOSARTAN POTASSIUM +AMLODIPINE BESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-262024-05-152024-05-174
11084/2018AMOXIKIDAMOXICILLIN TRIHYDRATE BP NOT APPLIED FULL ASSESSMENT 0000-00-00
Application date
2018-11-192018-11-242024-05-0318
128611/2020AMPIMED 500 APPLIED FOR GMP FULL ASSESSMENT
Application date
2021-08-172021-11-192021-11-24909
136325/2023ANTI D TRINBELIMAB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-022024-04-092024-05-174
141122/2019ASPORELIX INJECTIONCETRORELIX ACETATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-052024-04-092024-05-0417
1516276-2022ATAZANAVIR& RITONAVIRATAZANAVIR SULFATE + RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-07-172023-07-262023-08-23272
1612958/2022BATRACURIUM 2.5MLATRACURIUM BESYLATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-282024-04-022024-05-0417
1712958/2022AATRACURIUM 5MLATRACURIUM BESYLATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-272024-04-032024-05-174
185891/2021AZ-500AZITHROMYCIN DIHYDRATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-122024-03-262024-05-0417
1915705/2022AZITHROMYCINAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-092024-05-022024-05-174
201010/2019BACTOCLAV DRY SYRUPAMOXICillin 100mg+Potassium |Clavuranate 12.5mg/ APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2024-04-032024-04-162024-05-174
213365/2022BACTROSECSECNIDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-242024-04-302024-05-174
222329/2022BRUTAFLAM-60ETORICOXIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-142024-03-182024-05-0417
232330/2022BRUTAFLAM-90ETORICOXIB GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-132024-03-132024-05-0417
242860/2023CACHET\'S SALINE NASAL SPRAYSODIUM CHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-03-152023-03-182024-05-0417
251034/2019CANDIMALE-15ORNIDAZOLE + MICONAZOLE NOT APPLIED ABRIDGED 0000-00-00
Application date
2021-06-242021-08-112024-04-0546
263867/2019CARTIL SUPER FORTE PLUSGLUCOSAMINE PLUS MSM + DIACEREIN NOT APPLIED ABRIDGED 0000-00-00
Application date
2023-09-132023-12-202024-05-174
275906/2021CHLOZINE TABLETSCHLORPROMAZINE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-280000-00-002024-05-0417
2812959/2022ACISATRA 5MLCISATRACURIUM BESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-112024-05-082024-05-174
298859/2020CLARICIN-500CLARITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Round-1
2024-03-282024-04-122024-05-0516
300239/2021CLAVUMOCCID-500AMOXICILLIN/POTASSIUM CLAVULANATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-302024-05-132024-05-174
311638/2019CLOFAINS PARACEUTAMOL/ SODIUM DILOFENAC GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2024-02-022024-02-052024-05-0318
329090/2021CLOXACILLIN SODIUM CLOXACILLIN SODIUM GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2024-04-032024-04-302024-05-174
331065/2021CLOXARIN-250CLOXACILLIN APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Round-1
2024-03-282024-04-052024-05-0615
348612/2020CLOXISEL 500 APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2024-04-292024-05-022024-05-174
353143/2019CONTUS PAEDIATRIC LINCTUSCHLORPHENAMINE,PHENYLEPHINE&DEXTROMETHORPHAN LINCTUS APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2020-05-202021-06-162024-04-3021
360435/2019CURAM 400/57AMOXICILLINE+POTASSIUM CLAVULANIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2019-03-262019-04-012024-04-3021
372882/2023DABORAL 250AMINOSIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-212024-03-222024-05-0417
382889/2023DABORAL SYRUPAMINOSIDINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2024-03-252024-03-262024-04-3021
395367/2019DACOLD CAPSULESPARACETAMOL BP + CAFFEINE ANHYDROUS BP+ PSEUDOEPHEDRINE HCL BP + CHLORPHENIRAMINE MALEATE BP GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2023-12-062023-12-132024-05-174
408876/2020DAKASVIRDACLATASVIR DIHYDROCLORIDE NOT APPLIED FULL ASSESSMENT 0000-00-00
Application date
2021-11-190000-00-002021-11-19914
410084/2020DARUNAVIR ETHANOLATE + RITONAVIRDARUNAVIR ETHANOLATE + RITONAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-182021-08-192021-10-08956
426498/2021DARUNAVIR/RITONAVIRDARUNAVIR/ RITONAVIR APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2021-05-040000-00-002021-05-041113
4317772-2022DECETAXEL NEAPOLIS DOCETAXEL ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-022024-04-052024-05-174
4417774-2022DECETAXEL NEAPOLIS DOCETAXEL ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-132024-04-092024-05-174
450338/2021DESARROL 200MLCYPROPEPTADINE/ CARNITINE HCL/ ARGININE ASPARTATE NOT APPLIED ABRIDGED 0000-00-00
Application date
2023-12-132023-12-132024-04-0546
460234/2021DIARTEM IGDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-03-242024-03-122024-05-0417
470232/2021DIARTEM IG ADULTDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-04-192024-03-152024-05-0417
480238/2021DIARTEM IG SUSPDIHYDROARTEMISININ/ PIPERAQUIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-03-242024-03-142024-05-0417
497332/2021DIX TABLETSDIGOXIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-282024-04-042024-05-0417
505210/2020DOLIMEX MIGRAINEPARACETAMOL + CAFFEINE NOT APPLIED FULL ASSESSMENT 0000-00-00
Application date
2021-08-182021-08-192021-10-19945
513140/2019DREZ OINTMENTIODINATED-PROVIDONE&METRONIDAZOLE OINTMENT APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2020-06-102021-06-232024-04-3021
523145/2019DREZ POWDERIODATED-PROVIDONE&METRONIZADOLE POWDER APPLIED FOR GMP FULL ASSESSMENT
Round-1
2023-03-132023-03-162024-04-3021
533139/2019DREZ SOLUTIONIODATED-PROVIDONE&METRONIZADOLE SOLUTION APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2020-06-032021-06-192024-04-3021
540141/2021DYGLI M 50/1000SITAGLIPTIN + METFORMIN HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Round-1
2022-07-282023-10-312024-04-3021
55622/2018EFFERALGAN 1G EFFPARACETAMOL EFFERVESCENT 1G GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2024-04-302024-04-302024-05-0318
568604/2020ELMOX 250 SYRUPAMOXICILLIN APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2021-08-112021-08-242024-05-0318
5715575/2022EMPADIL 10EMPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-08-152024-03-152024-05-0417
5815576/2022EMPADIL 25EMPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-08-112024-03-152024-05-0417
5917459-2022EMPADIL-M 12.5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-202023-07-262023-08-23272
6017462-2022EMPADIL-M 12.5/500 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-08-072023-08-162023-08-23272
6117458-2022EMPADIL-M 5/1000 EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-08-072023-08-142023-08-23272
6217460-2022EMPADIL-M 5/500EMPAGLIFLOZIN USP + METFORMIN HCL USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-08-072023-08-142023-08-23272
633027/2023EMTRICITABINE/ TENOFOVIR ALFENAMIDEEMTRICITABINE/ TENOFOVIR ALFENAMIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-212023-07-272024-04-3021
64322/2018EZIUM-20MGESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-09-052023-10-052024-05-0318
65323/2018EZIUM-40MGESOMEPRAZOLE APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-09-072023-10-122024-05-174
6613957/2018FEVAROL PARACETAMOL, PHENYLEPHRINE,CHLORPHENIRAMINE MALEATE APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-11-202023-12-082024-05-0318
6715699/2022FINI-COUGH 15MG/5MLAMBROXOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-172024-04-182024-05-0417
6815685/2022FINI-COUGH 30MG/5MLAMBROXOL HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-112024-04-172024-05-0417
6915689/2022FINI-MAL 20/120ARTEMETHER/ LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-172024-04-242024-05-174
7015700/2022FINI-MAL 80/480ARTEMETHER& LUMEFANTRINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-112024-04-232024-05-174
710334/2019FLUCANOLFLUCLOXACILLINE APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2021-06-212021-07-052024-05-0318
722600/2019FLUOXINE 750CIPROFLOXACIN HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2020-05-202021-06-112024-04-3021
73088/2018FLUZOLEFLUCONAZOLE APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-11-152021-01-042024-05-174
745207/2020FUCLO-250FLUCLOXACILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-212021-08-302021-11-18915
755213/2020& 6689/2020FUCLO-500FLUCLOXACILLIN NOT APPLIED FULL ASSESSMENT
Application date
2021-08-152021-08-252021-11-29904
765211/2020FUCLO-500FLUCLOXACILLIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-202021-08-232021-11-18915
775886/2021GALLOP CAPSULESLOPERAMIDE HYDROCHLORIDE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-092024-05-152024-05-174
781036/2019GASTROCID LIQUID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2021-06-242024-03-122024-05-0417
793749/2021GLICOR MR 60MGGLICLAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-172024-04-222024-05-174
802878/2023GLUCOWELL 50VILDAGLIPTIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-242024-04-252024-05-174
812867/2023GLYSIT 10DAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-252024-03-262024-05-0417
822879/2023GLYSIT 5DAPAGLIFLOZIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-202024-03-252024-05-0417
832885/2023HARTEZE 10RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-132024-03-152024-05-0417
842886/2023HARTEZE 15RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-182024-03-192024-05-0417
852881/2023HARTEZE 20RIVAROXABAN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-202024-03-212024-05-0417
8618273-2022HELMADOL 400MG FCT ALBENDAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-212024-03-212024-05-0417
873944/2019HELMINTOX 125MG, SCORED FILM-COATED TABLETSPYRANTEL EMBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2020-07-012021-08-062024-05-0318
883945/2019HELMINTOX 125MG/2.5ML ORAL SUSPENSION (BOX OF 25 SACHETS)PYRANTEL EMBONATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2020-07-152021-08-072024-04-3021
893906/2023HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-152024-04-152024-05-0417
909087/2021HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE BP GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2024-03-132024-03-222024-05-174
912877/2023HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-212024-03-272024-05-0417
9215688/2022IBUPROFENIBUPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-222024-04-262024-05-174
9315686/2022IBUPROFEN 200IBUPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-242024-04-252024-05-174
9417771-2022IMATINIB NEAPOLIS IMATINIB MESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-192023-07-262023-08-23272
9517773-2022IMATINIB NEAPOLIS IMATINIB MESILATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-242023-07-272023-08-23272
9613854/2022INSUFOR 500MG METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-282024-04-032024-05-174
9713776/2022INSUFOR 850MG METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-02-292024-04-042024-05-0417
9816728-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-262024-04-182024-05-0417
9916729-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-022024-04-172024-05-0417
10016730-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-092024-04-192024-05-0417
10116819-2022IRYS GLIMEPIRIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-112024-04-152024-05-0417
10215791-2022IVERMECTIN IVERMECTIN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-252024-03-282024-05-174
1032602/2019IXINE 200 CEFIXIME TRIHYDRATE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2021-06-162021-06-222024-04-3021
10411204/2022LASTAVIN AM 5/160AMLODIPINE AND VALSARTAN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-08-072023-08-092023-08-23272
10514760/2022LASTAVIN AM PLUS 5/160/25AMLODIPINE/ VALSARTAN/ HYDROCHLOROTHIAZIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-08-102023-08-152023-08-23272
10617974-2022LETROZOLE NEAPOLISLETROZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-262023-08-252024-04-3021
10713951/2022LEVOFLOX 5MG/ML LEVOFLOXACIN HEMIHYDRATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-232023-07-272023-08-23272
1087622/2020LOMOH 40ENOXAPARIN SODIUM GMP CERTIFICATE AVAILABLE RECOGNITION 0000-00-00
Application date
2024-04-302024-04-302024-05-0417
109LUBREX-2020LUBREX EYE DROPSCARBOXYMETHYL CELLULOSE SODIUM APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Round-1
2023-09-012023-12-282024-05-0516
1105247/2020MALAVAN SUPPOARTESUNATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-202021-08-252021-11-18915
1111511/2019MARA MOJA TABLETS.ASPIRIN, PARACETAMOL, CAFFEINE ANHYDROUS GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2021-01-292021-03-252024-04-3021
11214062/2022MASRONE 2MGRISPERIDONE USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-252024-04-032024-05-0417
11310282/2021MEDIVEN-S OINTMENTBETAMETHASONE VALEARATE BP/ SALICYLIC ACID GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-232024-03-272024-05-174
1145881/2021METCLO TABLETSMETOCLOPRAMIDE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-082024-03-122024-05-0417
11515697/2022METFUR 1000METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-032024-04-112024-05-0417
11615703/2022METFUR 500METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-102024-04-102024-05-0417
11715684/2022METFUR 850METFORMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-082024-04-122024-05-0417
1185724/2022MOLENA 200MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2022-05-262022-06-282022-07-10681
11910354/2021MOLNAFLUMOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2021-12-200000-00-002022-01-11861
120406-2018MORCET-10ESCITALOPRAM APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2024-02-282024-03-062024-05-174
121407-2018MORCET-20ESCITALOPRAM APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2023-11-242024-04-012024-05-174
1225137/2021EMOXITAM 125MG SUSPENSIONAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2024-04-032024-04-092024-05-0417
1235137/2021FMOXITAM 250MG CAPSULEAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2024-03-212024-04-022024-05-0417
1245137/2021GMOXITAM 250MG SUSPENSIONAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2024-04-092024-04-102024-05-0417
1255137/2021HMOXITAM 500MG CAPSULESAMOXYCILLIN TRIHYDRATE APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2024-03-222024-03-272024-05-0417
12613947/2022MP 40METHYLPREDNISOLONE HYDROGEN SUCCINATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-022024-04-052024-05-0417
1272457/2022MURAXAL-10ALFUZOSIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-222024-03-252024-05-0417
1284283/2021NEOMYCIN SULFATENEOMYCIN SULFATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2022-04-202023-07-262023-08-23272
12910333/2022NEOTAGMINNEOSTIGMINE METHYLSULFATE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-132024-04-042024-05-174
1309235/2022NEUROMED 75MGPREGABALINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-04-272024-03-122024-05-0417
13112663/2018NEUTAS INJECTIONFILGRASTIM APPLIED FOR GMP FULL ASSESSMENT
Application date
2020-08-202020-08-312021-06-211065
1323146/2019NEUTRAFLUX SUSPENSIONALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE SUSPENSION APPLIED FOR GMP FULL ASSESSMENT
Application date
2020-09-012021-06-212024-04-3021
1333147/2019NEUTRAFLUX TABLETSALGINIC ACID, MAGNESIUM HYDROXIDE,ALUMINIUM HYDROXIDE,MAGNESIUM TRISILICATE&SIMETICONE TABLETS APPLIED FOR GMP FULL ASSESSMENT
Application date
2020-05-252021-06-232024-04-3021
1348265/2021NIFESTA-20NIFEDIPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-052024-04-092024-05-0417
1358800/2020NITROCONTIN 6.4DILUTED NITROGYCERIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-162021-09-132021-10-26938
1362327/2022NUROKIND INJMECOBALAMIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-122024-05-152024-05-174
1374003/2021OLAPIN-5OLANZAPINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2021-08-222021-11-282021-12-06897
1382077/2023PANTOTAB-LPANTOPRAZOLE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-272024-03-302024-05-174
13915698/2022PARACETAMOL ORAL SUSPENSIONPARACETAMOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-122024-04-162024-05-0417
1403419/2022PEMETREXED NEAPOLIS-100 PEMETREXED GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-07-202023-07-252023-08-23272
1413420/2022PEMETREXED NEAPOLIS-500PEMETREXED GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-132024-03-132024-05-0417
142RWANDA-FDA24/HM/0148PHENERGAN® 2%, creamPROMETHAZINE HCL APPLIED ABBRIDGED 0000-00-00
Application date
2024-03-132024-05-062024-05-174
1438003/2022PRINORELAX 15CYLOBENZAPINE HCL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-272024-04-052024-05-174
1447997/2022PRINORELAX 30MGCYCLOPENTOLATE HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-292024-04-042024-05-0417
1455902/2021PROMAGO SYRUPPROMETHAZINE HYDROCHLORIDE BP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-292024-04-302024-05-174
146RWANDA-FDA23/HM/0057RENEGEL SUSPENSIONALUMINIUM HYDR+MAGNES SUSP 100ML NOT APPLIED ABRIGDED 0000-00-00
Application date
2024-03-132024-05-072024-05-174
1470248/2021RIPAXIL-750CEFUROXIME AXETIL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-172024-05-072024-05-174
14813035/2022SARTILOSLOSARTAN POTASSIUM GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-042024-04-112024-05-0417
14913777/2022SERTOFEN 25MGDEXKETOPROFEN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-252024-04-292024-05-174
1506112/2022STRIPIRAVIR-200MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-05-272022-06-302022-07-10681
1516111/2022STRIPIRAVIR-400MOLNUPIRAVIR GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2022-05-242022-06-212022-07-10681
1525883/2021TIN-TIN TABLETSTINIDAZOLE BP GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2024-01-312024-04-222024-05-174
1530286/2021TRIALGIC IBUPROFEN/ PARACETAMOL/ CAFFEINE NOT APPLIED ABRIDGED 0000-00-00
Application date
2023-09-142023-11-172024-05-174
1542240/2019TRIMETABOL METOPINE,L-LYSINE HCL,DL-CARNITINE,THIAMINE HCL,PYRIDOXINE,CYANOCOBALAMIN APPLIED FOR GMP FULL ASSESSMENT 0000-00-00
Application date
2022-02-082024-03-142024-05-0417
1552570/2019TWYNSTA, 80 MG TELMISARTAN&AMLODIPINE GMP CERTIFICATE AVAILABLE ABRIDGED 0000-00-00
Application date
2023-12-062024-04-092024-04-0546
1560245/2021UPRAJECT-40PANTOPRAZOL GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-04-252024-03-192024-05-0417
157465/2022URINORMFEBUXOSTAT GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-04-232024-05-072024-05-174
1585117/2021UTRORONE 100PROGESTERONE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT
Application date
2023-08-152023-08-172023-08-23272
1594309/2019VAPTORROSUVASTATIN APPLIED FOR GMP ABRIDGED 0000-00-00
Application date
2021-08-082021-08-092024-05-174
1603200/2021VASTERN 25CINNARIZINE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2022-02-082022-02-122024-05-174
16114762/2022VILDARIL M 50/1000VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Round-1
2024-03-192024-03-272024-05-0615
16214765/2022VILDARIL M 50/500VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Round-1
2024-03-182024-04-092024-05-0615
16314763/2022VILDARIL M 50/850VILDAGLIPTIN/ METFORMIN HYDROCHLORIDE GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Round-1
2024-03-272024-04-102024-05-0615
1642621/2023XEBISCO 150PREGABALIN USP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2023-02-242024-03-192024-05-0417
1655212/2023Z-COT 20Rivaroxaban EP GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-04-192024-04-222024-05-174
1668570/2022ZIROMINAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-262024-03-272024-05-0417
1678572/2022ZIROMIN POWDER FOR ORAL SUSPENSIONAZITHROMYCIN GMP CERTIFICATE AVAILABLE FULL ASSESSMENT 0000-00-00
Application date
2024-03-282024-03-292024-05-0417