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Alkem Laboratories Limited — FDA Facility Profile

FEI 3008450172

Alkem Laboratories Limited is an FDA-registered facility (FEI 3008450172) located in Gujarat 393010, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

Facility Details

Location
Gujarat 393010 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1229200 (VAI Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945929 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-3800935-6/40003/1 (Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources