Biocon is an API and finished-dose manufacturer based in India. It holds 69 active US drug master files and 29 valid CEPs. Its filings concentrate with US FDA, AIFA (IT) and EDE (AE). Its GMP standing is certified by ANVISA (Brazil), EMA and CDSCO (India), among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 3 September 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Bengaluru, United Arab Emirates | Not on file |
| Iskandar Puteri, United Arab Emirates | Not on file |
| Johor, United Arab Emirates | Not on file |
| Bangalore, Colombia | Not on file |
| EDGWARE, United Kingdom | Not on file |
| Bangalore, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Rosuvastatin | EDQM, SFDA (Saudi Arabia), US FDA | 11 |
| Everolimus | EDQM, SFDA (Saudi Arabia), US FDA | 10 |
| Sitagliptin | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Tacrolimus | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Fingolimod | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Mycophenolate Mofetil | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Posaconazole | SFDA (Saudi Arabia), US FDA | 5 |
| Simvastatin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Fluvastatin Sodium | EDQM | 4 |
| Atorvastatin | SFDA (Saudi Arabia), US FDA | 3 |
| Deferasirox | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Fluvastatin | US FDA | 3 |
| Linagliptin | SFDA (Saudi Arabia), US FDA | 3 |
| Mycophenolic Acid | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Pioglitazone | SFDA (Saudi Arabia), US FDA | 3 |
| Pravastatin | EDQM, US FDA | 3 |
| Teriflunomide | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Dapagliflozin | US FDA | 2 |
| Dasatinib | SFDA (Saudi Arabia), US FDA | 2 |
| Lenalidomide | SFDA (Saudi Arabia), US FDA | 2 |
| Micafungin | SFDA (Saudi Arabia), US FDA | 2 |
| Mirabegron | EDQM, US FDA | 2 |
| Orlistat | SFDA (Saudi Arabia), US FDA | 2 |
| Repaglinide | EDQM, US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Sacubitril | SFDA (Saudi Arabia), US FDA | 2 |
| Sirolimus | SFDA (Saudi Arabia), US FDA | 2 |
| Vildagliptin | SFDA (Saudi Arabia), US FDA | 2 |
| Anidulafungin | US FDA | 1 |
| Apixaban | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 102 | 6 |
| AIFA (IT) | 68 | None |
| EDE (AE) | 31 | None |
| CDSCO (India) | 30 | 8 |
| NPRA (MY) | 30 | None |
| EMA | 29 | 9 |
| ANVISA (Brazil) | None | 14 |
| MHRA (UK) | None | 4 |
| EAEU_EEC | None | 1 |
| FDA (GH) | None | 1 |
| INVIMA (CO) | None | 1 |
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