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🏥 FDA: Cipla USA, Inc. — Class III

healthcarebearishSource: FDA
85%Confidence
0Views
FDASource
2026-03-28Date

Summary

Cipla's Nilotinib Capsules recall due to stability test failures indicates potential quality control issues at its India manufacturing site, which could impact its US market reputation and supply chain reliability. This may create opportunities for competitors in the oncology generic drug market, particularly for leukemia treatments.

Actionable: Monitor Cipla's manufacturing compliance reports and consider diversifying supplier sources for nilotinib or similar oncology generics.

AI Confidence: 85%

Data Points

firmCipla USA, Inc.
classificationClass III
statusOngoing
distributionU.S.A. Nationwide
productNilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc

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