Home / Import refusals / AEK-7697916-8/10003/1

FDA Import Refusal AEK-7697916-8/10003/1 — Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited — FEI 3009915929

The FDA refused shipment AEK-7697916-8/10003/1 from Glenmark Pharmaceuticals Limited (India) on October 9, 2025. The refused product falls under Drugs and Biologics — FORMOTEROL FUMARATE. Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 9, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
63BCQ32 FORMOTEROL FUMARATE
Charges
118,75

Recent inspections

  • 1252922 (NAI Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1226884 (NAI Fri Dec 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122444 (NAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065438 (VAI Fri Aug 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978521 (VAI Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

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