Laurus Labs is an API and finished-dose manufacturer based in India. It holds 118 active US drug master files and 28 valid CEPs. Its filings concentrate with US FDA, CDSCO (India) and MCAZ (ZW). Its GMP standing is certified by EMA, MFDS (Korea) and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 31 January 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Anakapalli, India | 3017037090 |
| Anakapalli, India | 3014255847 |
| Medchal-Malkajgiri, India | 3006527015 |
| Anakapalli, India | 3007083664 |
| Hyderabad, India | Not on file |
| Anakapalli, India | 3011538548 |
3 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Dolutegravir | US FDA | 8 |
| Lamivudine | EDQM, SFDA (Saudi Arabia), US FDA | 7 |
| Tenofovir Disoproxil | SFDA (Saudi Arabia), US FDA | 7 |
| Abacavir | EDQM, US FDA | 5 |
| Efavirenz | SFDA (Saudi Arabia), US FDA | 5 |
| Bortezomib | SFDA (Saudi Arabia), US FDA | 4 |
| Carfilzomib | SFDA (Saudi Arabia), US FDA | 4 |
| Darunavir | US FDA | 4 |
| Gemcitabine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Imatinib | US FDA | 4 |
| Imatinib Mesilate | EDQM, SFDA (Saudi Arabia) | 4 |
| Irinotecan | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Metformin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Oxaliplatin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Tenofovir Alafenamide | US FDA | 4 |
| Azacitidine | SFDA (Saudi Arabia), US FDA | 3 |
| Carboplatin | EDQM, US FDA | 3 |
| Cisplatin | EDQM, US FDA | 3 |
| Docetaxel | EDQM, US FDA | 3 |
| Emtricitabine | SFDA (Saudi Arabia), US FDA | 3 |
| Enzalutamide | SFDA (Saudi Arabia), US FDA | 3 |
| Hydrochlorothiazide | EDQM, US FDA | 3 |
| Hydroxychloroquine | EDQM, US FDA | 3 |
| Lopinavir | EDQM, US FDA | 3 |
| Oseltamivir | EDQM, US FDA | 3 |
| Pirfenidone | EDQM, US FDA | 3 |
| Pregabalin | EDQM, US FDA | 3 |
| Ritonavir | EDQM, US FDA | 3 |
| Sitagliptin | EDQM, US FDA | 3 |
| Apalutamide | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 38 | 3 |
| CDSCO (India) | 19 | None |
| MCAZ (ZW) | 17 | None |
| TMDA (TZ) | 15 | None |
| NAFDAC (NG) | 11 | 1 |
| ZAMRA (ZM) | 11 | None |
| EMA | None | 8 |
| MFDS (Korea) | None | 4 |
| MINPROMTORG (RU) | None | 2 |
| ANVISA (Brazil) | None | 2 |
| FDA (GH) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 | $781.9M | Not reported | Not reported |
| 2025 | $637.4M | Not reported | Not reported |
| 2024 | $602.4M | Not reported | Not reported |
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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