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Alkem Laboratories Limited — FDA Facility Profile

FEI 3006370524

Alkem Laboratories Limited is an FDA-registered facility (FEI 3006370524) located in Dadra & Nagar Haveli and Daman & Diu 396210, IN. Registered operations: ANALYSIS; MANUFACTURE; PACK; REPACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

Location
Dadra & Nagar Haveli and Daman & Diu 396210 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE; PACK; REPACK
Source
decrs

Recent inspections

  • 1106347 (NAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080442 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046054 (VAI Tue Mar 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989408 (VAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854604 (VAI Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 761720 (VAI Fri Dec 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • D82-2245271-5/31/1 (Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9ES-0063345-1/11/1 (Mon Oct 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-4068513-5/11/1 (Fri Mar 05 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7312001-5/11/2 (Wed Jun 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7312001-5/11/1 (Wed Jun 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-9293231-9/11/1 (Fri Mar 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2330835-3/3/1 (Tue Jul 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9ES-0028010-5/1/1 (Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9ES-0028010-5/2/1 (Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 201-8892301-4/1/1 (Mon Jun 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources