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Dr Reddy’s labs gain zero observations from USFDA for Srikakulum plant

Dr Reddy’s Laboratories has informed exchanges that the audit of its formulations Srikakulum Plant (SEZ) Unit II, Andhra Pradesh, by the US Food Drug Administration has been complete and after the audit, the US health regulator issued zero observations to its plant.

Meanwhile, on November 9, the Regulatory Authority of Germany (Regierung von Oberbayem) had concluded the follow-on audit of its other formulations manufacturing facility in Duvvada, Vishakapatnam. The facility is considered compliant and the EU-GMP certification continues to remain active with one specific exclusion of a new product. The company will be submitting a detailed corrective and preventive action plan to the authorities.

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