Dr. Reddy's Duvvada unit gets six observations from German regulator
German regulatory authority has issued six major oBSErvations pertaining to good manufacturing practices (GMPs) of Dr. Reddy's Laboratories' (DRL) for its Visakhapatnam plant. The company notified the same in a BSE notification. Drugs, manufactured in this plant, are exported to the European Union (EU). The firm said that it'll be submitting a Corrective and Preventive Action plan (CAPA) for the same. Here's more.
This is not the first time
The auditor has notified the pharma major that its EU-GMP certification will be extended up to November 2018 only after the CAPA gets approved. It will take a call on the continuation of EU-GMP certification after reviewing DRL's compliance with the CAPA and other regulatory measures. Earlier, US Food and Drug Administration (US FDA) had made 13 observations about the same plant.
Another blow to the firm
Earlier, DRL's German subsidiary Betapharm Arzneimittel stated it has not received word from the Regulatory Authority of Germany on the renewal of the GMP compliance certificate of its formulations manufacturing unit 2 in Bachupally near Hyderabad post inspection. DRL said in a statement that until the noncompliance notification is revoked, it will not be able to dispatch any drugs to EU.
The timeline is brewing!
The timeline is brewing!
