Zhejiang Apeloa Kangyu Pharmaceutical is an API manufacturer based in China. It holds 7 active US drug master files and 5 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 July 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Jinhua, China | Not on file |
| Hengdian, China | Not on file |
| China, China | 3003744129 |
| Molecule | Regulators | Docs |
|---|---|---|
| Levofloxacin | EDQM, SFDA (Saudi Arabia), US FDA | 3 |
| Dextromethorphan | EDQM, US FDA | 2 |
| Pseudoephedrine | EDQM, US FDA | 2 |
| Amantadine | US FDA | 1 |
| Diphenhydramine | US FDA | 1 |
| Lovastatin | US FDA | 1 |
| Marbofloxacin For Veterinary Use | EDQM | 1 |
| Ofloxacin | EDQM | 1 |
| Triclosan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
Choose your molecules and target markets. Zhejiang Apeloa Kangyu Pharmaceutical comes back tiered against every other supplier able to file there.
Start for free