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Apotex Research Private Limited — FDA Facility Profile

FEI 3006076314

Apotex Research Private Limited is an FDA-registered facility (FEI 3006076314) located in Karnataka 560099, IN. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 7 FDA inspections and 2 compliance actions at this facility.

Facility Details

Location
Karnataka 560099 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1233067 (VAI Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081769 (NAI Sat Feb 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 970670 (VAI Fri May 20 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886801 (OAI Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851564 (VAI Fri Jul 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801824 (VAI Fri Jun 22 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 659921 (VAI Sat Apr 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • 231-1648494-5/11/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1648554-6/11/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1648554-6/21/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1648554-6/31/1 (Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1650313-2/11/1 (Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1650313-2/21/1 (Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-1650313-2/31/1 (Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3260229-8/1/1 (Tue Mar 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3273427-3/1/1 (Tue Mar 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3273427-3/2/1 (Tue Mar 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources