German regulators decided to not renew the good manufacturing practice compliance certificate of an Indian manufacturing facility operated by a wholly owned subsidiary of Dr. Reddy's Laboratories Ltd.
The move by the Regulatory Authority of Germany follows its recent inspection of betapharm Arzneimittel GmbH's unit 2 plant in Bachupally, Hyderabad.
No products from the plant will be admissible into the European Union until the regulator revokes its noncompliance notification. Betapharm will initiate the the next inspection by inviting the German regulator.