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Health
FDA revokes Cipla's CFA drug sales licence in Pune
✍️ The Indian Express
🗓 29 Aug 2026, 03:37 AM
👁 2
India's Food and Drug Administration has withdrawn the licence allowing Cipla to market its CFA drug in Pune, citing regulatory concerns.
The Food and Drug Administration (FDA) announced that it has cancelled the licence permitting Cipla to sell its CFA drug in Pune. The regulatory body said the decision was taken after a review of compliance requirements.
Cipla will now have to suspend distribution of the CFA formulation in the Pune market until it secures a new approval. The move is expected to affect pharmacies and hospitals that source the medication from the company.
The company has not released an official statement, but sources indicate that Cipla is assessing the next steps to address the FDA's concerns. This action underscores the FDA's ongoing scrutiny of pharmaceutical licences to ensure safety and quality standards.
The cancellation highlights the importance of strict adherence to regulatory norms for drug manufacturers operating in India, especially in high‑demand therapeutic segments.
Cipla will now have to suspend distribution of the CFA formulation in the Pune market until it secures a new approval. The move is expected to affect pharmacies and hospitals that source the medication from the company.
The company has not released an official statement, but sources indicate that Cipla is assessing the next steps to address the FDA's concerns. This action underscores the FDA's ongoing scrutiny of pharmaceutical licences to ensure safety and quality standards.
The cancellation highlights the importance of strict adherence to regulatory norms for drug manufacturers operating in India, especially in high‑demand therapeutic segments.