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FDA Import Refusal AEK-7896703-9/40003/1 — Alkem Laboratories Pvt Ltd

Alkem Laboratories Pvt Ltd — FEI 3012189024

The FDA refused shipment AEK-7896703-9/40003/1 from Alkem Laboratories Pvt Ltd (India) on Nov 13, 2025. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charges: 118,3280 This firm has 2 other import refusals on record.

Refusal Details

Date
Nov 13, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
56BDY03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
118,3280

Other import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.