80%Confidence
0Views
FDASource
2026-05-27Date
Summary
Failed impurity tests for JB Chemicals' enalapril tablets indicate quality control lapses, risking regulatory action and customer loss. This could impact Rising Pharma's distribution and JB Chemicals' export credibility.
Actionable: Reduce exposure to JB Chemicals and Rising Pharma; review quality compliance of other Indian manufacturers.
AI Confidence: 80%
Data Points
firmJB Chemicals and Pharmaceuticals Ltd
classificationClass II
statusOngoing
distributionNationwide in the USA
productEnalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Ph
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