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Apotex Pharmachem India Pvt. Ltd. — FDA Facility Profile

FEI 3005466325

Apotex Pharmachem India Pvt. Ltd. is an FDA-registered facility (FEI 3005466325) located in Karnataka 560 099, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Karnataka 560 099 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1263710 (VAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180313 (NAI Fri Sep 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118806 (VAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057873 (VAI Tue Jun 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978926 (VAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868946 (OAI Fri Jan 31 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 711567 (VAI Wed Dec 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • EG6-3197344-3/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3176162-4/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3159327-4/1/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-3159327-4/2/1 (Wed Sep 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821731-9/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821732-7/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821737-6/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821834-1/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821920-8/1/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EG6-1821920-8/2/1 (Wed Jul 28 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources