Zydus Lifesciences arm’s pediatric Menkes disease drug CUTX-101 flagged by USFDA in CRL

Zydus noted that it had recently submitted responses to the USFDA following a re-inspection in September 2025, proving the facility’s CGMP compliance, and is currently awaiting the Establishment Inspection Report (EIR). Shares of Zydus Lifesciences Ltd ended at ₹993.90, up by ₹12.20, or 1.24%, on the BSE.

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