Alkem Laboratories is an API and finished-dose manufacturer based in India. It holds 37 active US drug master files and 4 valid CEPs. Its filings concentrate with DKMA (DK), US FDA and EFDA (ET). Its GMP standing is certified by CDSCO (India), NAFDAC (NG) and EMA, among 8 authorities. Its most recent recorded inspection, by US FDA, closed on 27 March 2024 as VAI. Customs aggregates show $332.8M of exports covering 6,356 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 |
|---|---|
| Nani Daman, United Arab Emirates | Not on file |
| Baddi, United Arab Emirates | Not on file |
| BADDI, India | Not on file |
| Mumbai, India | Not on file |
| DISTRICT SOLAN, India | Not on file |
| at post ankleshwar ankleshwar bharuch, India | Not on file |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Amlodipine | US FDA | 2 |
| Aripiprazole | EDQM, US FDA | 2 |
| Duloxetine | EDQM, US FDA | 2 |
| Esomeprazole | US FDA | 2 |
| Nebivolol | EDQM, US FDA | 2 |
| Quetiapine | EDQM, US FDA | 2 |
| Tapentadol | US FDA | 2 |
| Apremilast | US FDA | 1 |
| Azilsartan Medoxomil | US FDA | 1 |
| Bempedoic Acid | US FDA | 1 |
| Canagliflozin | US FDA | 1 |
| Cannabidiol | US FDA | 1 |
| Dabigatran Etexilate | US FDA | 1 |
| Dalfampridine | US FDA | 1 |
| Dexmethylphenidate | US FDA | 1 |
| Dimethyl Fumarate | US FDA | 1 |
| Dronedarone | US FDA | 1 |
| Eluxadoline | US FDA | 1 |
| Esketamine | US FDA | 1 |
| Eslicarbazepine Acetate | US FDA | 1 |
| Ezetimibe | US FDA | 1 |
| Lansoprazole | US FDA | 1 |
| Lurasidone | US FDA | 1 |
| Mesalazine | US FDA | 1 |
| Methylphenidate | US FDA | 1 |
| Olanzapine | US FDA | 1 |
| Rabeprazole | US FDA | 1 |
| Rasagiline | US FDA | 1 |
| Riluzole | US FDA | 1 |
| Rizatriptan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DKMA (DK) | 285 | None |
| US FDA | 95 | 2 |
| EFDA (ET) | 73 | None |
| INVIMA (CO) | 49 | None |
| CDSCO (India) | 44 | 6 |
| NPRA (MY) | 44 | None |
| NAFDAC (NG) | None | 5 |
| EMA | None | 4 |
| FDA (GH) | None | 2 |
| MHRA (UK) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| TMDA (TZ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $54.9M | 22 |
| 2025 | $1.5B | $332.8M | 32 |
| 2024 | $1.5B | $284.0M | 29 |
| 2023 | $1.4B | $241.0M | 29 |
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. Alkem Laboratories 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.