Shandong New Time Pharmaceutical Co., Ltd.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- China
- Registered address
- No. 1, North Outer Ring Road, Feixian, Linyi, Shandong 273499, China (CHN)
- Operations here
- analysisapi manufacturelabelmanufacturepacksterilize
- FDA identifiers
- FEI 3006704412 · DUNS 545298254
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-07-09
- VAIDrug Quality Assurance2018-05-11
- VAIDrug Quality Assurance2016-03-25
- VAIDrug Quality Assurance2013-08-23
Drugs this plant is listed as making
7 distinct drugs across 21 products name this site in their FDA label.
- IsofluraneShandong New Time Pharmaceutical Co., Ltd.
- Isosorbide MononitrateShandong New Time Pharmaceutical Co., Ltd.
- Milrinone LactateMullan Pharmaceutical Inc.
- Oseltamivir phosphateShandong New Time Pharmaceutical Co., Ltd.
- oxaliplatinShandong New Time Pharmaceutical Co., Ltd.
- Rosuvastatin CalciumShandong New Time Pharmaceutical Co., Ltd.
- SevofluraneMullan Pharmaceutical Inc.
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.