Dr Reddy’s to Restart Exports to EU from Vizag Unit
Dr. Reddy’s Laboratories has now received clearance from a German regulatory authority to resume European exports from its Visakhapatnam facility.
“The corrective and preventive action plan submitted by us has been accepted by the regulator. Consequently, the regulator has permitted production to start again from this facility for the EU market,” Dr. Reddy’s Laboratories said in a regulatory filing.
In a regulatory blow, the pharma major was reprimanded and had been issued six major observations related to good manufacturing practices (GMPs) for its plant in Visakhapatnam by a German regulatory authority in September this year, following which the company had submitted a Corrective and Preventive Action plan (CAPA) to the authorities.
Further, the drugmaker also disclosed in a regulatory filing that its corrective and preventive action plan was accepted by the regulator, adding that the site will be re-inspected next year.
