The U.S. FDA issued Dr. Reddy’s a Form-483 with 13 observations relating to cGMPs deviations at the Visakhapatnam, India facility.
The drugmaker manufacturers injectable cancer formulations at the facility at Duvvada in Visakhapatnam. Dr. Reddy's had received an FDA warning letter with regard to the same facility in November 2015. A re-audit of the facility was scheduled for the first quarter of 2017, after the commitments made by the drugmaker in its response letter were completed.
Specific details about the deviations were not shared by the company, but analysts predict that the remediation process will take at least one to one-and-a-half years and will impact future product filings and approvals in the U.S.
Last month, the company’s API manufacturing plant at Miryalaguda in Telangana was issued a Form-483 by the FDA with three observations relating to violation of norms.
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