Shandong New Time Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 34 active US drug master files and 8 valid CEPs. Its filings concentrate with US FDA, TMDA (TZ) and EFDA (ET). Its GMP standing is certified by EMA, MFDS (Korea) and US FDA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 9 July 2024 as VAI.
NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.
| Site | FDA FEI |
|---|---|
| SHANDONG, China | Not on file |
| Linyi, China | Not on file |
| China, China | 3006704412 |
| Molecule | Regulators | Docs |
|---|---|---|
| Isoflurane | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Potassium Clavulanate | EDQM, SFDA (Saudi Arabia) | 4 |
| Sevoflurane | EDQM, SFDA (Saudi Arabia), US FDA | 4 |
| Clavulanic Acid | US FDA | 3 |
| Zoledronic Acid | EDQM, US FDA | 3 |
| Epirubicin | US FDA | 2 |
| Ketorolac | US FDA | 2 |
| Milrinone | SFDA (Saudi Arabia), US FDA | 2 |
| Montelukast | EDQM, US FDA | 2 |
| Bempedoic Acid | US FDA | 1 |
| Cabazitaxel | US FDA | 1 |
| Carfilzomib | US FDA | 1 |
| Dalfampridine | US FDA | 1 |
| Daunorubicin | US FDA | 1 |
| Decitabine | US FDA | 1 |
| Elagolix | US FDA | 1 |
| Esomeprazole | US FDA | 1 |
| Fosaprepitant | US FDA | 1 |
| Gadoteridol | US FDA | 1 |
| Gimeracil | US FDA | 1 |
| Isosorbide Mononitrate | EDQM | 1 |
| Lasmiditan | US FDA | 1 |
| Linagliptin | US FDA | 1 |
| Mycophenolate Mofetil | US FDA | 1 |
| Orlistat | US FDA | 1 |
| Oteracil | US FDA | 1 |
| Sitagliptin | US FDA | 1 |
| Tadalafil | US FDA | 1 |
| Tegafur | US FDA | 1 |
| Temsirolimus | US FDA | 1 |
Also appears on these molecule pages
| Regulator | Filings | GMP certificates |
|---|---|---|
| US FDA | 14 | 1 |
| TMDA (TZ) | 2 | 1 |
| EFDA (ET) | 1 | None |
| JFDA (JO) | 1 | None |
| UZPHARM (UZ) | 1 | None |
| MINSA (CR) | 1 | None |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
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