Biological E is a finished-dose manufacturer based in India. It appears in 62 regulatory filings across 12 regulators, without an active US DMF or CEP on file. Its filings concentrate with EDE (AE), MCAZ (ZW) and COFEPRIS (MX). Its GMP standing is certified by ANVISA (Brazil), FDA (GH) and CDSCO (India), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 12 November 2024 as VAI. Customs aggregates show $350.7M of exports covering 1,175 molecules to 112 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Medchal, United Arab Emirates | Not on file |
| Medchal, India | 3009522832 |
| Medchal, India | 3008377265 |
| TELANGANA, India | Not on file |
| Medchal Malkajgiri, India | Not on file |
| Regulator | Filings | GMP certificates |
|---|---|---|
| EDE (AE) | 29 | None |
| MCAZ (ZW) | 8 | None |
| COFEPRIS (MX) | 3 | None |
| JFDA (JO) | 3 | None |
| NMRC (NA) | 3 | None |
| NAFDAC (NG) | 3 | 1 |
| ANVISA (Brazil) | None | 4 |
| FDA (GH) | None | 2 |
| CDSCO (India) | None | 2 |
| EMA | None | 2 |
| MHRA (UK) | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $32.1M | 54 |
| 2025 | Not reported | $350.7M | 112 |
| 2024 | Not reported | $224.8M | 120 |
| 2023 | Not reported | $181.9M | 116 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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