Dr. Reddys Laboratories Ltd.
-24.30 (-1.91%) German Regulatory issues zero critical, six major observations to Dr Reddy’s Duvvada facility
Date: 08-09-2017Regulatory Authority of Germany (Regierung von Oberbayern) has concluded an audit of Dr Reddy’s Laboratories’ Formulations manufacturing facility in Duvvada, Vishakapatnam, with zero critical and six major observations. Products manufactured at the facility are not currently 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. The Facility’s compliance with the CAPA and other applicable regulations will be reviewed again by the Regulator by the November 2018 for continuation of the Facility’s EU-GMP certification.
Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.