Home / Import refusals / AEK-8035262-6/21/1

FDA Import Refusal AEK-8035262-6/21/1 — Emcure Pharmaceuticals Limited

Emcure Pharmaceuticals Limited — FEI 3005151215

The FDA refused shipment AEK-8035262-6/21/1 from Emcure Pharmaceuticals Limited (India) on December 26, 2024. The refused product falls under Drugs and Biologics — ARMODAFINIL (STIMULANT). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 26, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
66BDY47 ARMODAFINIL (STIMULANT)
Charges
27

Recent inspections

  • 1079858 (OAI Wed Feb 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075227 (NAI Tue Oct 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023101 (OAI Thu Aug 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912371 (OAI Wed Feb 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867389 (VAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-7180460-1/32/1 (Tue Jul 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-8379746-8/21/1 (Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4765929-9/11/2 (Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4765929-9/11/1 (Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4210396-2/11/1 (Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources