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Intas Pharmaceuticals Limited — FDA Facility Profile

FEI 3004011473

Intas Pharmaceuticals Limited is an FDA-registered facility (FEI 3004011473) located in Gujarat 382213, IN. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Gujarat 382213 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1191818 (OAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119170 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092798 (VAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992746 (VAI Wed Oct 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910188 (NAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847008 (NAI Thu Jun 27 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755472 (VAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-0162570-5/40002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0516804-5/30002/1 (Wed Aug 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • KH5-4157161-9/20002/1 (Wed Aug 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7457773-3/20002/1 (Mon Aug 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7231304-0/12/1 (Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7262024-6/12/1 (Thu Jul 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7265900-4/62/1 (Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 231-4226207-7/11/1 (Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6023796-4/11/2 (Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1166470-4/11/1 (Fri Oct 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources