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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