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 |
| Mumbai, India | Not on file |
| BADDI, India | Not on file |
| DISTRICT SOLAN, India | Not on file |
| G.I.D.C., 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 We do not publish the identity of any buyer.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.
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