Amoli Organics is an API manufacturer based in India. It holds 45 active US drug master files. Its filings concentrate with MINSA (CR), NCELS (KZ) and INVIMA (CO). Its GMP standing is certified by CDSCO (India), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 4 March 2024 as VAI. Customs aggregates show $2.3M of exports covering 69 molecules to 31 destinations in 2024.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| shed area gidc vapi vapi 396 195 valsad, India | Not on file |
| Vadodara, India | Not on file |
| Valsad, India | 3004810446 |
| Vadodara, India | 3007836955 |
| Vadodara, India | Not on file |
| vapivapi 396 195valsad, India | Not on file |
| Molecule | Regulators | Docs |
|---|---|---|
| Diclofenac | SFDA (Saudi Arabia), US FDA | 11 |
| Celecoxib | SFDA (Saudi Arabia), US FDA | 3 |
| Dapagliflozin | US FDA | 3 |
| Rosuvastatin | SFDA (Saudi Arabia), US FDA | 3 |
| Venlafaxine | SFDA (Saudi Arabia), US FDA | 3 |
| Atorvastatin | SFDA (Saudi Arabia), US FDA | 2 |
| Carbamazepine | SFDA (Saudi Arabia), US FDA | 2 |
| Desvenlafaxine | US FDA | 2 |
| Diclofenac Diethylamine | SFDA (Saudi Arabia) | 2 |
| Levetiracetam | SFDA (Saudi Arabia), US FDA | 2 |
| Sacubitril/Valsartan | US FDA | 2 |
| Sildenafil | SFDA (Saudi Arabia), US FDA | 2 |
| Sitagliptin | US FDA | 2 |
| Aceclofenac | SFDA (Saudi Arabia) | 1 |
| Apixaban | US FDA | 1 |
| Cariprazine | US FDA | 1 |
| Chlorthalidone | US FDA | 1 |
| Clotrimazole | US FDA | 1 |
| Deferasirox | US FDA | 1 |
| Dimethyl Fumarate | US FDA | 1 |
| Edoxaban | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Enzalutamide | US FDA | 1 |
| Hydrochlorothiazide | US FDA | 1 |
| Mesalazine | US FDA | 1 |
| Mirabegron | US FDA | 1 |
| Olmesartan | US FDA | 1 |
| Oxcarbazepine | US FDA | 1 |
| Pirfenidone | US FDA | 1 |
| Ranolazine | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 5 | None |
| NCELS (KZ) | 1 | None |
| INVIMA (CO) | 1 | None |
| CDSCO (India) | None | 6 |
| US FDA | None | 2 |
| EMA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2024 | Not reported | $2.3M | 31 |
| 2023 | Not reported | $31.0M | 82 |
| 2022 | Not reported | $47.5M | 89 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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