Henan Lihua Pharmaceutical is an API manufacturer based in China. It holds 28 active US drug master files across a filed portfolio of 14 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 13 July 2021 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Anyang, Henan, China | Not on file |
| China, China | 3001164052 |
| Molecule | Regulators | Docs |
|---|---|---|
| Hydrocortisone | US FDA | 6 |
| Betamethasone | US FDA | 4 |
| Prednisolone | SFDA (Saudi Arabia), US FDA | 4 |
| Methylprednisolone | US FDA | 3 |
| Mometasone Furoate | US FDA | 2 |
| Prednisone | US FDA | 2 |
| Beclomethasone Dipropionate | US FDA | 1 |
| Budesonide | US FDA | 1 |
| Cortisone Acetate | US FDA | 1 |
| Dexamethasone | US FDA | 1 |
| Fludrocortisone | US FDA | 1 |
| Fluocinolone Acetonide | US FDA | 1 |
| Fluorometholone | US FDA | 1 |
| Triamcinolone | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| MINSA (CR) | 7 | None |
| EMA | None | 1 |
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