Lupin is an API and finished-dose manufacturer based in India. It holds 135 active US drug master files and 37 valid CEPs. Its filings concentrate with US FDA, INFARMED (PT) and DAV (Vietnam). Its GMP standing is certified by EMA, CDSCO (India) and MHRA (UK), among 9 authorities. Its most recent recorded inspection, by US FDA, closed on 16 September 2025 as VAI. Customs aggregates show $1.2B of exports covering 8,216 molecules to 127 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| DISTRICT RAISEN, India | Not on file |
| bhasa tal padra dabhasa 391 440 vadodara, India | Not on file |
| Ankleshwar, India | 3002807510 |
| Mandideep, India | 3007756473 |
| Pithampur, India | 3009107538 |
| Dhar, India | 3009831799 |
6 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Cephalexin | EDQM, US FDA | 4 |
| Duloxetine | EDQM, US FDA | 4 |
| Ethambutol | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Abacavir | EDQM, US FDA | 3 |
| Cefuroxime | US FDA | 3 |
| Ezetimibe | SFDA (Saudi Arabia), US FDA | 3 |
| Levetiracetam | EDQM, US FDA | 3 |
| Levonorgestrel | EDQM, US FDA | 3 |
| Levothyroxine | EDQM, US FDA | 3 |
| Lisinopril | EDQM, US FDA | 3 |
| Quetiapine | EDQM, US FDA | 3 |
| Rifaximin | EDQM, US FDA | 3 |
| Sertraline | EDQM, US FDA | 3 |
| Simvastatin | EDQM, US FDA | 3 |
| Tiotropium | EDQM, US FDA | 3 |
| Zolpidem | EDQM, US FDA | 3 |
| Apremilast | US FDA | 2 |
| Atorvastatin | EDQM | 2 |
| Azithromycin | US FDA | 2 |
| Cefaclor | EDQM | 2 |
| Dolutegravir | US FDA | 2 |
| Empagliflozin | SFDA (Saudi Arabia), US FDA | 2 |
| Estradiol | US FDA | 2 |
| Ethinylestradiol | EDQM | 2 |
| Febuxostat | US FDA | 2 |
| Imipramine | US FDA | 2 |
| Iron Sucrose | US FDA | 2 |
| Losartan | US FDA | 2 |
| Lovastatin | US FDA | 2 |
| Norethisterone | US FDA | 2 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 558 | 7 |
| INFARMED (PT) | 42 | None |
| DAV (Vietnam) | 40 | None |
| CDSCO (India) | 32 | 13 |
| MEDSAFE (NZ) | 28 | None |
| ZAMRA (ZM) | 22 | None |
| EMA | None | 13 |
| MHRA (UK) | None | 9 |
| ANVISA (Brazil) | None | 7 |
| NAFDAC (NG) | None | 2 |
| MFDS (Korea) | None | 2 |
| FDA (GH) | None | 2 |
| TMDA (TZ) | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | $3.3B | $195.0M | 64 |
| 2025 | $2.7B | $1.2B | 127 |
| 2024 | $2.4B | $979.0M | 119 |
| 2023 | Not reported | $790.5M | 106 |
Export figures are customs aggregates. We do not publish the identity of any buyer.
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.
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