Morepen Laboratories is an API manufacturer based in India. It holds 31 active US drug master files and 14 valid CEPs across a filed portfolio of 25 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as NAI. Customs aggregates show $83.0M of exports covering 1,748 molecules to 87 destinations in 2025.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| New Delhi, India | Not on file |
| Solan, India | 3002807612 |
| Solan, India | 3003897648 |
| Baddi, India | 3006785414 |
| Molecule | Regulators | Docs |
|---|---|---|
| Rosuvastatin | EDQM, SFDA (Saudi Arabia), US FDA | 9 |
| Sitagliptin | EDQM, SFDA (Saudi Arabia), US FDA | 5 |
| Apixaban | SFDA (Saudi Arabia), US FDA | 4 |
| Atorvastatin | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Loratadine | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Desloratadine | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Linagliptin | SFDA (Saudi Arabia), US FDA | 3 |
| Saxagliptin | SFDA (Saudi Arabia), US FDA | 3 |
| Dapagliflozin | US FDA | 2 |
| Fexofenadine | EDQM, US FDA | 2 |
| Montelukast | SFDA (Saudi Arabia), US FDA | 2 |
| Rivaroxaban | EDQM, US FDA | 2 |
| Rupatadine | EDQM, US FDA | 2 |
| Vortioxetine | US FDA | 2 |
| Bempedoic Acid | US FDA | 1 |
| Brexpiprazole | US FDA | 1 |
| Dapagliflozin Propanediol | SFDA (Saudi Arabia) | 1 |
| Edoxaban | US FDA | 1 |
| Empagliflozin | US FDA | 1 |
| Ertugliflozin | US FDA | 1 |
| Montelukast Sodium | EDQM | 1 |
| Olmesartan | US FDA | 1 |
| Olmesartan Medoxomil | EDQM | 1 |
| Ticagrelor | US FDA | 1 |
| Vonoprazan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| CDSCO (India) | 3 | None |
| MINSA (CR) | 2 | None |
| Year | Revenue | Exports | Destinations |
|---|---|---|---|
| 2026 YTD | Not reported | $15.4M | 57 |
| 2025 | $208.0M | $83.0M | 87 |
| 2024 | $202.0M | $74.9M | 76 |
| 2023 | $171.7M | $71.9M | 74 |
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 We do not publish the identity of any buyer.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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