Shijiazhuang Lonzeal Pharmaceuticals is an API manufacturer based in China. It holds 9 active US drug master files and 2 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 18 October 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Shenze, China | Not on file |
| Shijiazhuang, China | Not on file |
| China, China | 3010066204 |
| Molecule | Regulators | Docs |
|---|---|---|
| Esomeprazole | EDQM, US FDA | 2 |
| Lamivudine | EDQM, US FDA | 2 |
| Dolutegravir | US FDA | 1 |
| Emtricitabine | US FDA | 1 |
| Paroxetine | US FDA | 1 |
| Pregabalin | US FDA | 1 |
| Tenofovir Alafenamide | US FDA | 1 |
| Tenofovir Disoproxil | US FDA | 1 |
| Vonoprazan | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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