Glenmark Pharmaceuticals s.r.o is an API and finished-dose manufacturer based in India. It appears in 2,751 regulatory filings across 40 regulators, without an active US DMF or CEP on file. Its filings concentrate with MHRA (UK), EMA and US FDA. Its GMP standing is certified by EMA, CDSCO (India) and ANVISA (Brazil), among 11 authorities. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Nasik, United Arab Emirates | Not on file |
| Tehsil Baddi, United Arab Emirates | Not on file |
| Goa, United Arab Emirates | Not on file |
| Himachal Pradesh, United Arab Emirates | Not on file |
| Parque industrial De Pilar, United Arab Emirates | Not on file |
| SAO PAULO, Brazil | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Lornoxicam | SFDA (Saudi Arabia) | 4 |
| Desloratadine | SFDA (Saudi Arabia) | 3 |
| Adapalene | SFDA (Saudi Arabia) | 2 |
| Apremilast | SFDA (Saudi Arabia) | 2 |
| Deferasirox | SFDA (Saudi Arabia) | 2 |
| Glimepiride | SFDA (Saudi Arabia) | 2 |
| Perindopril | SFDA (Saudi Arabia) | 2 |
| Sitagliptin | SFDA (Saudi Arabia) | 2 |
| Apixaban | SFDA (Saudi Arabia) | 1 |
| Atovaquone | SFDA (Saudi Arabia) | 1 |
| Esomeprazole | SFDA (Saudi Arabia) | 1 |
| Etoricoxib | SFDA (Saudi Arabia) | 1 |
| Ezetimibe | SFDA (Saudi Arabia) | 1 |
| Fluconazole | SFDA (Saudi Arabia) | 1 |
| Lurasidone | SFDA (Saudi Arabia) | 1 |
| Nintedanib | SFDA (Saudi Arabia) | 1 |
| Olmesartan Medoxomil | SFDA (Saudi Arabia) | 1 |
| Perindopril Erbumine | SFDA (Saudi Arabia) | 1 |
| Perindopril-Tert-Butylamine | SFDA (Saudi Arabia) | 1 |
| Rasagiline | SFDA (Saudi Arabia) | 1 |
| Rosuvastatin | SFDA (Saudi Arabia) | 1 |
| Tazarotene | SFDA (Saudi Arabia) | 1 |
| Telmisartan | SFDA (Saudi Arabia) | 1 |
| Ticagrelor | SFDA (Saudi Arabia) | 1 |
| Tofacitinib | SFDA (Saudi Arabia) | 1 |
| Vildagliptin | SFDA (Saudi Arabia) | 1 |
| Voriconazole | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MHRA (UK) | 457 | 6 |
| EMA | 304 | 38 |
| US FDA | 278 | 1 |
| ANVISA (Brazil) | 229 | 8 |
| SAHPRA (ZA) | 140 | None |
| DAV (Vietnam) | 115 | None |
| CDSCO (India) | None | 13 |
| NAFDAC (NG) | None | 3 |
| UZPHARM (UZ) | None | 3 |
| INVIMA (CO) | None | 2 |
| MFDS (Korea) | None | 2 |
| TMDA (TZ) | None | 1 |
| FDA (GH) | None | 1 |
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