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Monday, August 28, 2017

Statement of Non-Compliance report with GMP Violations @ Dr.reddy's Lab










Dr. Reddy’s Laboratories on Thursday (Aug 10th) said the German regulator had not renewed GMP (good manufacturing practice) compliance certificate of its formulations manufacturing unit-2 in Bachupally, Hyderabad, following an inspection.

Pending revocation of the non-compliance notification, the plant will not be able to make any further dispatch to the European Union, DRL said in a stock exchange filing.

The drugmaker’s German subsidiary betapharm Arzneimittel GmbH had received a communication from the Regulatory Authority of Germany (Regierung von Oberbayern) on Wednesday (Aug 9th) night. The GMP compliance certificate in respect of the formulations manufacturing unit-2 plant in Bachupally is not renewed consequent to the recent inspection of the plant, the subsidiary had informed.

For the non-compliance notification to be revoked, another inspection would be required, which has to be initiated by an invitation from betapharm, DRL said.

The filing did not share details of violations leading to the certificate not getting renewed. A spokesperson of the company said the regulator had made some observations, details of which would be available once the document, in German, is translated.

Report for the Miryalaguda facility, which the company said indicated closure of the audit.



Source: The Hindu, EMA



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