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 TMDA (TZ), 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 |
| UZPHARM (UZ) | 1 | None |
| MINSA (CR) | 1 | None |
| JFDA (JO) | 1 | None |
| EMA | None | 3 |
| MFDS (Korea) | None | 2 |
| ANVISA (Brazil) | None | 1 |
Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.
Choose your molecules and target markets. Shandong New Time Pharmaceutical comes back tiered against every other supplier able to file there.
Start for freeRanked by shared active ingredients where we have them, otherwise by country and comparable credentials.