Zydus Lifesciences is an API and finished-dose manufacturer based in India. It holds 150 active US drug master files and 52 valid CEPs. Its filings concentrate with US FDA, SAHPRA (ZA) and ANVISA (Brazil). Its GMP standing is certified by CDSCO (India), EMA and ANVISA (Brazil), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 17 June 2025 as VAI. Customs aggregates show $277.7M of exports covering 2,454 molecules to 73 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 |
| RIO DE JANEIRO, Brazil | Not on file |
| RIO DE JANEIRO, Brazil | Not on file |
| Ahmedabad, Colombia | Not on file |
| Nanterre, France | Not on file |
| NORTHAMPTON, United Kingdom | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Clopidogrel | EDQM, US FDA | 7 |
| Mesalazine | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Amlodipine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Esomeprazole | EDQM, US FDA | 4 |
| Hydroxychloroquine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Omeprazole | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Topiramate | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Atorvastatin | EDQM, US FDA | 3 |
| Azathioprine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Azelastine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Duloxetine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Lamotrigine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Meloxicam | EDQM, US FDA | 3 |
| Pregabalin | EDQM, US FDA | 3 |
| Sitagliptin | US FDA | 3 |
| Trazodone | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Venlafaxine | EDQM, US FDA | 3 |
| Aripiprazole | EDQM, US FDA | 2 |
| Atenolol | EDQM, US FDA | 2 |
| Atomoxetine | EDQM, US FDA | 2 |
| Atorvastatin Calcium | EDQM | 2 |
| Buspirone | EDQM, US FDA | 2 |
| Candesartan | US FDA | 2 |
| Carvedilol | EDQM, US FDA | 2 |
| Clindamycin | US FDA | 2 |
| Clopidogrel Hydrogen Sulfate | EDQM | 2 |
| Dabigatran Etexilate | SFDA (Saudi Arabia), US FDA | 2 |
| Dapagliflozin | US FDA | 2 |
| Donepezil | US FDA | 2 |
| Empagliflozin | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 688 | 7 |
| SAHPRA (ZA) | 344 | None |
| ANVISA (Brazil) | 295 | 10 |
| ANSM (FR) | 281 | 3 |
| EMA | 179 | 12 |
| DAV (Vietnam) | 154 | None |
| CDSCO (India) | None | 53 |
| MHRA (UK) | None | 2 |
| TMDA (TZ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $123.9M | 58 |
| 2025 | Not reported | $277.7M | 73 |
| 2024 | Not reported | $57.6M | 58 |
| 2023 | Not reported | $42.6M | 58 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Zydus Lifesciences comes back tiered against every other supplier able to file there.
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