FDC is an API and finished-dose manufacturer based in India. It holds 15 active US drug master files and 48 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with MCAZ (ZW), EFDA (ET) and TMDA (TZ). Its GMP standing is certified by MHRA (UK), EMA and FDA (GH), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as NAI. Customs aggregates show $15.5M of exports covering 673 molecules to 64 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Aurangabad, United Arab Emirates | Not on file |
| Chhatrapati Sambhajinagar, India | 3003204330 |
| VERNA SALCETTE, India | Not on file |
| AURANGABAD, India | Not on file |
| VERNA, India | Not on file |
| Roha, India | 3002806958 |
3 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Miconazole | EDQM, SFDA (Saudi Arabia), US FDA | 8 |
| Flurbiprofen | EDQM, US FDA | 7 |
| Albuterol | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Cinnarizine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Timolol | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Brimonidine | EDQM, US FDA | 4 |
| Bromhexine | EDQM, SFDA (Saudi Arabia) | 4 |
| Dorzolamide | EDQM, US FDA | 4 |
| Econazole | EDQM, US FDA | 4 |
| Latanoprost | EDQM, US FDA | 4 |
| Betaxolol | EDQM | 3 |
| Fluconazole | EDQM | 3 |
| Glycopyrronium | EDQM | 3 |
| Rupatadine | EDQM | 3 |
| Arformoterol | US FDA | 1 |
| Bimatoprost | US FDA | 1 |
| Brinzolamide | US FDA | 1 |
| Nepafenac | US FDA | 1 |
| Olopatadine | US FDA | 1 |
| Semaglutide | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MCAZ (ZW) | 30 | None |
| EFDA (ET) | 26 | None |
| TMDA (TZ) | 24 | None |
| MHRA (UK) | 19 | 2 |
| EMA | 17 | 2 |
| US FDA | 10 | None |
| FDA (GH) | None | 1 |
| ZAMRA (ZM) | None | 1 |
| NAFDAC (NG) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $7.0M | 62 |
| 2025 | Not reported | $15.5M | 64 |
| 2024 | Not reported | $13.6M | 66 |
| 2023 | Not reported | $78.7M | 58 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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