Lee Pharma is an API and finished-dose manufacturer based in India. It holds 54 active US drug master files and 16 valid CEPs. Its filings concentrate with DH (HK), CDSCO (India) and ARCSA (EC). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 February 2025 as NAI. Customs aggregates show $43.8M of exports covering 921 molecules to 66 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Visakhapatnam, United Arab Emirates | Not on file |
| Telangana, United Arab Emirates | Not on file |
| Hyderabad, India | Not on file |
| Anakapalli, India | 3030599910 |
| Visakhapatnam, India | 3018490749 |
| Jinnaram, India | Not on file |
1 further sites are on record.
| Molecule | Regulators | Docs |
|---|---|---|
| Esomeprazole | EDQM, SFDA (Saudi Arabia), US FDA | 6 |
| Voriconazole | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Bilastine | SFDA (Saudi Arabia), US FDA | 3 |
| Omeprazole | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Sitagliptin | EDQM, US FDA | 3 |
| Amlodipine | US FDA | 2 |
| Empagliflozin | SFDA (Saudi Arabia), US FDA | 2 |
| Itraconazole | SFDA (Saudi Arabia), US FDA | 2 |
| Lacosamide | EDQM, US FDA | 2 |
| Lansoprazole | EDQM, US FDA | 2 |
| Olanzapine | EDQM, US FDA | 2 |
| Pantoprazole | EDQM, US FDA | 2 |
| Resmetirom | US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Rosuvastatin | EDQM, US FDA | 2 |
| Sacubitril | US FDA | 2 |
| Sertraline | SFDA (Saudi Arabia), US FDA | 2 |
| Tegoprazan | US FDA | 2 |
| Ticagrelor | EDQM, US FDA | 2 |
| Varenicline | US FDA | 2 |
| Vildagliptin | SFDA (Saudi Arabia), US FDA | 2 |
| Apixaban | US FDA | 1 |
| Bempedoic Acid | US FDA | 1 |
| Brivaracetam | US FDA | 1 |
| Cariprazine | US FDA | 1 |
| Cenobamate | US FDA | 1 |
| Dabigatran Etexilate | US FDA | 1 |
| Dapagliflozin | US FDA | 1 |
| Dexlansoprazole | US FDA | 1 |
| Eluxadoline | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| DH (HK) | 30 | None |
| CDSCO (India) | 17 | None |
| ARCSA (EC) | 8 | None |
| BOMRA (BW) | 7 | None |
| MINSA (CR) | 2 | None |
| EDE (AE) | 1 | None |
| EMA | None | 3 |
| US FDA | None | 1 |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $9.1M | 28 |
| 2025 | Not reported | $43.8M | 66 |
| 2024 | Not reported | $45.0M | 52 |
| 2023 | Not reported | $35.1M | 52 |
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.
Choose your molecules and target markets. Lee Pharma comes back tiered against every other supplier able to file there.
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