Zhejiang Lepu Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| China, China | 3004414647 |
| Molecule | Regulators | Docs |
|---|---|---|
| Atorvastatin | US FDA | 2 |
| Rosuvastatin | US FDA | 2 |
| Azelastine | US FDA | 1 |
| Clopidogrel | US FDA | 1 |
| Esomeprazole | US FDA | 1 |
| Idelalisib | US FDA | 1 |
| Linezolid | US FDA | 1 |
| Macitentan | SFDA (Saudi Arabia) | 1 |
| Pazopanib | US FDA | 1 |
| Ponatinib | US FDA | 1 |
| Vortioxetine Hemihydrobromide | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
Choose your molecules and target markets. Zhejiang Lepu Pharmaceutical comes back tiered against every other supplier able to file there.
Start for free