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Importance
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Trust
89
Urgency
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REGULATORY · PRIMARY SOURCE
Alchymars ICM SM Private Limited - 724429 - 05/21/2026
Analysis
FDA found serious manufacturing problems at an Indian API factory. If the facility supplies peptide drug ingredients, batches sent to the US may be at risk.
- FDA issued warning letter 320-26-77 to Alchymars ICM SM Private Limited on May 21, 2026
- Inspection found cracked gaskets, rust on product-contact surfaces, and standing water on production floors
- Facility located in Alathur, Tamil Nadu, India; inspected November 28 to December 4, 2025
FDA Drug Approvals & Databases25d
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