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FDA Import Refusal AEK-9409404-0/100003/1 — Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited — FEI 3005757050

The FDA refused shipment AEK-9409404-0/100003/1 from Glenmark Pharmaceuticals Limited (India) on February 6, 2026. The refused product falls under Drugs and Biologics — CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 6, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61WDJ04 CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1172425 (OAI Wed Jun 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1070594 (NAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031652 (VAI Sat Nov 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929619 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802324 (NAI Fri Aug 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-0861603-8/30002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0490709-2/40002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0487274-2/90002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0615929-6/10002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0679067-8/30002/1 (Mon Jun 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources