Concord Biotech is an API manufacturer based in India. It holds 22 active US drug master files and 13 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with ARCSA (EC), DAV (Vietnam) and TMDA (TZ). Its GMP standing is certified by EMA, CDSCO (India) and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 2 May 2025 as VAI. Customs aggregates show $60.8M of exports covering 723 molecules to 54 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Ahmedabad, United Arab Emirates | Not on file |
| Kheda, India | 3020052335 |
| Ahmedabad, India | 3012520698 |
| Ahmedabad, India | 3004126703 |
| Kheda, India | Not on file |
| kheda 387 520, India | Not on file |
1 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Mupirocin | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Mycophenolic Acid | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Tacrolimus | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Cyclosporine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Everolimus | EDQM, US FDA | 2 |
| Mitomycin | EDQM, US FDA | 2 |
| Mycophenolate Mofetil | EDQM | 2 |
| Pravastatin | EDQM, US FDA | 2 |
| Vancomycin | EDQM, US FDA | 2 |
| Dactinomycin | US FDA | 1 |
| Lovastatin | US FDA | 1 |
| Midostaurin | US FDA | 1 |
| Mycophenolate Sodium | EDQM | 1 |
| Nystatin | US FDA | 1 |
| Pimecrolimus | US FDA | 1 |
| Romidepsin | US FDA | 1 |
| Sirolimus | US FDA | 1 |
| Staurosporine | US FDA | 1 |
| Temsirolimus | US FDA | 1 |
| Voclosporin | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| ARCSA (EC) | 9 | None |
| DAV (Vietnam) | 7 | None |
| TMDA (TZ) | 7 | None |
| US FDA | 5 | 2 |
| EDE (AE) | 4 | None |
| MINSA (CR) | 4 | None |
| EMA | None | 5 |
| CDSCO (India) | None | 3 |
| MFDS (Korea) | None | 2 |
| NAFDAC (NG) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $9.6M | 27 |
| 2025 | Not reported | $60.8M | 54 |
| 2024 | Not reported | $58.2M | 54 |
| 2023 | Not reported | $66.6M | 51 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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