95%Confidence
0Views
FDASource
2026-05-26Date
Summary
Ajanta Pharma's duloxetine product contains a nitrosamine impurity above FDA limits, indicating CGMP deficiencies that could lead to product recalls and regulatory penalties. This may erode trust in Ajanta's manufacturing quality and impact its US market access.
Actionable: Divest from Ajanta Pharma and its US distributor, and avoid exposure to generic duloxetine from this manufacturer.
AI Confidence: 95%
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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