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Amphastar Nanjing Pharmaceuticals — FDA Facility Profile

FEI 3009805706

Amphastar Nanjing Pharmaceuticals is an FDA-registered facility (FEI 3009805706) located in Jiangsu 210038, CN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Jiangsu 210038 (CN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1269036 (NAI Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107981 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036696 (NAI Thu Oct 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969870 (NAI Fri Apr 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874298 (VAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 286-7012499-0/12/4 (Mon Aug 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • W33-0774949-7/1/1 (Mon Mar 15 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources