Dr Reddy’s Labs informed exchanges that the Regulatory Authority of Germany (Regierung von Oberbayern), concluded an audit of formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations. Products manufactured at the facility are not currently exported to the European Union.
The company will be submitting a corrective and preventive action plan (CAPA) to the authorities.
The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA.
The facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of EU-GMP certification.
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