Shanghai Pharma Group Changzhou Kony Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 November 2023 as NAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| Luoyang Town, China | Not on file |
| China, China | 3004175957 |
| Molecule | Regulators | Docs |
|---|---|---|
| Ganciclovir | EDQM, US FDA | 2 |
| Valganciclovir | EDQM, US FDA | 2 |
| Ciclopirox | EDQM | 1 |
| Ciclopirox Olamine | EDQM | 1 |
| Eslicarbazepine Acetate | US FDA | 1 |
| Famciclovir | US FDA | 1 |
| Penciclovir | SFDA (Saudi Arabia) | 1 |
| Perindopril Tert-Butylamine | EDQM | 1 |
| Tamsulosin | EDQM | 1 |
| Valaciclovir | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | None | 1 |
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