Shandong Xinhua Pharmaceutical is an API manufacturer based in United States. It holds 42 active US drug master files across a filed portfolio of 17 molecules. Its filings concentrate with US FDA, MINSA (CR) and ARCSA (EC). Its GMP standing is certified by MFDS (Korea).
| Molecule | Regulators | Docs |
|---|---|---|
| Acetylsalicylic Acid | SFDA (Saudi Arabia), US FDA | 5 |
| Caffeine | SFDA (Saudi Arabia), US FDA | 4 |
| Glimepiride | US FDA | 4 |
| Hydrocortisone | US FDA | 4 |
| Ibuprofen | US FDA | 4 |
| Prednisone | US FDA | 4 |
| Carbidopa | SFDA (Saudi Arabia), US FDA | 3 |
| Levodopa | SFDA (Saudi Arabia), US FDA | 3 |
| Calcium Polycarbophil | US FDA | 2 |
| Meloxicam | US FDA | 2 |
| Metamizole | US FDA | 2 |
| Phenobarbital | US FDA | 2 |
| Prednisolone | US FDA | 2 |
| Sevelamer | US FDA | 2 |
| Theophylline | US FDA | 2 |
| Trimethoprim | US FDA | 2 |
| Antipyrine | SFDA (Saudi Arabia) | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 4 | None |
| MINSA (CR) | 3 | None |
| ARCSA (EC) | 1 | None |
| EFDA (ET) | 1 | None |
| JFDA (JO) | 1 | None |
| MFDS (Korea) | None | 2 |
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