Express Pharma

DRL’s Visakhapatnam unit gets six observations by German regulator

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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

Dr Reddys Laboratories (DRL) said the German drug regulator has concluded the audit of its Visakhapatnam formulations facility with six major observations.

“The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit of our formulations facility in Duvvada, Visakhapatnam with zero critical and six major observations,” DRL said in a filing to BSE.

It said the products manufactured at the facility are currently not exported to the EU.

“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,” it added.

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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