Ami Lifesciences is an API and finished-dose manufacturer based in India. It holds 39 active US drug master files and 16 valid CEPs. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by EDQM, CDSCO (India) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as VAI. Customs aggregates show $78.7M of exports covering 1,698 molecules to 72 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Karakhadi, India | Not on file |
| tal padra karakhadi 391 450 vadodara, India | Not on file |
| Vadodara, India | 3009456513 |
| karakhadi 391 450vadodara, India | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Sitagliptin | EDQM, US FDA | 4 |
| Brivaracetam | SFDA (Saudi Arabia), US FDA | 3 |
| Desvenlafaxine | SFDA (Saudi Arabia), US FDA | 3 |
| Diacerein | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Itopride | SFDA (Saudi Arabia) | 3 |
| Tadalafil | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Tranexamic Acid | EDQM, SFDA (Saudi Arabia) | 3 |
| Vonoprazan | SFDA (Saudi Arabia), US FDA | 3 |
| Ambroxol | EDQM | 2 |
| Betahistine Dihydrochloride | EDQM, SFDA (Saudi Arabia) | 2 |
| Dapagliflozin | US FDA | 2 |
| Dicyclomine | EDQM, US FDA | 2 |
| Febuxostat | SFDA (Saudi Arabia), US FDA | 2 |
| Finerenone | US FDA | 2 |
| Mirabegron | EDQM, US FDA | 2 |
| Mirogabalin | US FDA | 2 |
| Oxcarbazepine | EDQM, US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Sevelamer | US FDA | 2 |
| Bempedoic Acid | US FDA | 1 |
| Benzonatate | US FDA | 1 |
| Dapoxetine | SFDA (Saudi Arabia) | 1 |
| Daprodustat | US FDA | 1 |
| Edoxaban | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Eslicarbazepine Acetate | US FDA | 1 |
| Fezolinetant | US FDA | 1 |
| Fluvoxamine | US FDA | 1 |
| Gliclazide | EDQM | 1 |
| Hydralazine | US FDA | 1 |
| Lipoic Acid | EDQM | 1 |
| Resmetirom | US FDA | 1 |
| Tapentadol | EDQM | 1 |
| Tegoprazan | US FDA | 1 |
| Tolvaptan | US FDA | 1 |
| Vadadustat | US FDA | 1 |
| Venlafaxine | EDQM | 1 |
| Vibegron | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 10 | 3 |
| MINSA (CR) | 2 | None |
| EDQM | None | 16 |
| MFDS (Korea) | None | 2 |
| EMA | None | 2 |
| US FDA | None | 1 |
| WHO (PQ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $9.1M | 36 |
| 2025 | Not reported | $78.7M | 72 |
| 2024 | Not reported | $76.5M | 71 |
| 2023 | Not reported | $112.2M | 75 |
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. Ami Lifesciences comes back tiered against every other supplier able to file there.
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