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Alkem Laboratories Limited — FDA Facility Profile

FEI 3006851796

Alkem Laboratories Limited is an FDA-registered facility (FEI 3006851796) located in Gujarat 393002, IN. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 3 FDA inspections at this facility.

Facility Details

Location
Gujarat 393002 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1206190 (NAI Fri Apr 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998189 (VAI Fri Dec 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856244 (VAI Sat Nov 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • SCS-3249890-3/21/1 (Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0311853-6/11/1 (Thu Jan 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources