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Import refusals
/ 113-8490170-5/21/1
113-8490170-5/21/1
Glenmark Pharmaceuticals Limited — FEI 3008565058
Recent inspections
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))
962557
(VAI Fri Feb 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (708270)
(Fri Jul 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
AEK-9274924-9/90003/1
(Tue Feb 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
AEK-9409404-0/100003/1
(Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-0770066-3/20003/1
(Fri Jan 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
799-0358947-4/130003/1
(Mon Dec 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-9624690-8/20003/1
(Fri Dec 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
Refusal Details
Date
January 24, 2019
Country
India
Product Category
Drugs and Biologics
Product Code
63LDA04 SEVELAMER HYDROCHLORIDE (PHOSPHATE BINDER)
Charges
75