Covalent Laboratories is an API manufacturer based in India. It holds 7 active US drug master files and 2 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as NAI. Customs aggregates show $75.7M of exports covering 590 molecules to 32 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Hyderabad, India | Not on file |
| Sangareddy, India | Not on file |
| Sangareddy District, India | 3004590215 |
| Molecule | Regulators | Docs |
|---|---|---|
| Cefdinir | SFDA (Saudi Arabia), US FDA | 5 |
| Cefixime | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Cefuroxime | US FDA | 2 |
| Cefpodoxime | US FDA | 1 |
| Cefpodoxime Proxetil | SFDA (Saudi Arabia) | 1 |
| Cefprozil | US FDA | 1 |
| Cefuroxime Axetil | EDQM | 1 |
| Cepodoxime Proxelil | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 1 | None |
| MFDS (Korea) | None | 2 |
| EMA | None | 1 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $11.8M | 27 |
| 2025 | Not reported | $75.7M | 32 |
| 2024 | Not reported | $87.8M | 36 |
| 2023 | Not reported | $96.1M | 33 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Choose your molecules and target markets. Covalent Laboratories comes back tiered against every other supplier able to file there.
Start for free