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DRL’s Duvvada unit undergoes German regulator’s follow-on-audit

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The facility is considered compliant and the EU-GMP certification continues to remain active with one specific exclusion of a new product

Dr Reddy’s Laboratories (DRL) said that German regulatory authority has completed the follow-on audit of Duvvada manufacturing facility in Visakhapatnam and the EU-GMP certification of the plant remains active excluding for one new product.

“On November 9, 2018, the Regulatory Authority of Germany (Regierung von Oberbayem) concluded the follow-on audit of our formulations manufacturing facility in Duvvada, Visakhapatnam,” Dr Reddy’s Labs said in a BSE filing.

The facility is considered compliant and the EU-GMP certification continues to remain active with one specific exclusion of a new product, it added.

“The company will be submitting a detailed corrective and preventive action plan (CAPA) to the authorities,” it said.

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