Home / Import refusals / AEK-7725026-1/11/1

FDA Import Refusal AEK-7725026-1/11/1 — Glenmark Pharmaceuticals Limited

Glenmark Pharmaceuticals Limited — FEI 3008565058

The FDA refused shipment AEK-7725026-1/11/1 from Glenmark Pharmaceuticals Limited (India) on August 24, 2020. The refused product falls under Drugs and Biologics — TELMISARTAN (ANTI-HYPERTENSIVE - PART II). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 24, 2020
Country
India
Product Category
Drugs and Biologics
Product Code
62ODA09 TELMISARTAN (ANTI-HYPERTENSIVE - PART II)
Charges
75

Recent inspections

  • 1260403 (OAI Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122868 (NAI Tue Feb 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107098 (NAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053034 (VAI Thu May 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028538 (NAI Sat Aug 26 2017 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