90%Confidence
0Views
FDASource
2026-05-27Date
Summary
Nitrosamine impurity in Ajanta Pharma's duloxetine capsules above FDA limits poses regulatory and safety risks. This could lead to product recalls, sales loss, and increased scrutiny on Indian manufacturers.
Actionable: Short Ajanta Pharma shares or avoid exposure; watch for FDA warning letters or import alerts.
AI Confidence: 90%
Data Points
firmAjanta Pharma Ltd.
classificationClass II
statusOngoing
distributionNationwide within U.S
productDuloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-0
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