FDA knocks Lupin plant with warning letter after drugmaker failed to remedy operational woes

Months after the FDA demanded Lupin act on failures at its Mandideep, India finished dose plant, the Indian drugmaker was waiting for the other shoe to fall. It fell in a form of a warning letter. Lupin was hit with the warning letter after an “earlier intimation” from the FDA in March requiring Lupin to address a smorgasbord of manufacturing and data safety concerns, the company said in a regulatory filing (PDF) with the Bombay Stock Exchange. The drugmaker said its Mandideep facility had no outstanding drug applications and did not expect that the letter would “have an impact on disruption of supplies or the existing revenues from operations of this facility.”

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