Alembic Pharmaceuticals is an API and finished-dose manufacturer based in India. It holds 145 active US drug master files and 124 valid CEPs. Its filings concentrate with US FDA, DAV (Vietnam) and Health Canada. Its GMP standing is certified by CDSCO (India), EMA and US FDA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 31 May 2025 as VAI. Customs aggregates show $429.5M of exports covering 9,342 molecules to 77 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Panchmahal, United Arab Emirates | Not on file |
| PANCHMAHAL DISTRICT, India | Not on file |
| GUJARAT, India | Not on file |
| at panelav tal halol panelav panchmahal, India | Not on file |
| at panelav tal halol panelav panchmahal, India | Not on file |
| at panelav tal halol panelav panchmahal, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Azithromycin | EDQM, SFDA (Saudi Arabia), US FDA | 9 |
| Lacosamide | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Telmisartan | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Duloxetine | EDQM, US FDA | 6 |
| Fenofibrate | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Fingolimod | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Nitrofurantoin | EDQM, US FDA | 6 |
| Rivastigmine | EDQM, US FDA | 6 |
| Aripiprazole | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Rivaroxaban | EDQM, US FDA | 5 |
| Solifenacin Succinate | EDQM, US FDA | 5 |
| Teriflunomide | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Clarithromycin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Clonidine | EDQM, US FDA | 4 |
| Erythromycin | EDQM, US FDA | 4 |
| Etoricoxib | SFDA (Saudi Arabia), US FDA | 4 |
| Irbesartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Leflunomide | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Linezolid | SFDA (Saudi Arabia), US FDA | 4 |
| Macitentan | SFDA (Saudi Arabia), US FDA | 4 |
| Pregabalin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Sorafenib | EDQM, US FDA | 4 |
| Tadalafil | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Ticagrelor | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Valsartan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Venlafaxine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Warfarin | EDQM, US FDA | 4 |
| Candesartan Cilexetil | EDQM, SFDA (Saudi Arabia) | 3 |
| Celecoxib | EDQM, US FDA | 3 |
| Chlordiazepoxide | EDQM, US FDA | 3 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 475 | 5 |
| DAV (Vietnam) | 30 | None |
| Health Canada | 29 | None |
| AEMPS (ES) | 22 | None |
| ISP (CL) | 19 | None |
| MINSA (CR) | 17 | None |
| CDSCO (India) | None | 17 |
| EMA | None | 7 |
| ANVISA (Brazil) | None | 5 |
| MFDS (Korea) | None | 2 |
| MHRA (UK) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $68.2M | 58 |
| 2025 | $765.7M | $429.5M | 77 |
| 2024 | $744.4M | $401.0M | 77 |
| 2023 | $684.6M | $374.7M | 80 |
Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.
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. Alembic Pharmaceuticals comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.