The Regulatory Authority of Germany (Regierung von Oberbayern) has concluded its audit of Dr Reddy’s Laboratories Ltd’s formulations manufacturing facility in Duvvada, Visakhapatnam with six major observations.
Audit for the facility was concluded "with zero critical and six major observations'',’ the Hyderabad-based company said in a statement issued today.
Products manufactured at the facility are currently being exported to the European Union (EU).
"The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves a Corrective and Preventive Action Plan (CAPA) to be submitted by Dr Reddy’s to the authorities. The company will be submitting CAPA in due course.''
The facility’s compliance with CAPA and other applicable regulations will be reviewed again by the German regulator by November 2018 for continuation of its certification.
Dr Reddy’s scrip slumped 3.19 per cent to Rs 2,153 on the Bombay Stock Exchange today.