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Sun Pharmaceutical Industries Limited — FDA Facility Profile

FEI 3002809586

Sun Pharmaceutical Industries Limited is an FDA-registered facility (FEI 3002809586) located in Gujarat 389350, IN. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections and 2 compliance actions at this facility.

Facility Details

Location
Gujarat 389350 (IN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1272871 (OAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169254 (OAI Mon May 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112832 (OAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095656 (NAI Tue Jun 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076538 (NAI Thu Dec 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064495 (NAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042525 (VAI Fri Feb 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996364 (OAI Thu Dec 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910402 (OAI Tue Sep 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802067 (VAI Fri Sep 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-0329279-3/50002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-9751970-5/20002/2 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7736330-5/10003/1 (Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7487919-1/10003/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7487919-1/20003/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7401410-9/10002/1 (Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1070631-0/112/1 (Thu Jun 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1117084-7/32/1 (Wed Jun 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1117084-7/102/1 (Wed Jun 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7182928-5/12/1 (Thu Jun 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources