US FDA issues a warning letter to Natco Pharma's Telangana plant due to quality concerns.

US FDA issues warning letter to Natco Pharma's Telangana manufacturing plant due to quality concerns. Inspection resulted in eight observations, but Natco expects no impact on supplies or existing revenues, but delays or withholding of pending product approvals are possible. Natco plans to respond to FDA's concerns within stipulated timelines and work closely with the agency for compliance.

April 09, 2024
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