Moneycontrol PRO
Check Credit Score
Check Credit Score
HomeNewsBusiness

Dr Reddy's Vizag unit gets 6 observations by German regulator

"The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit of our formulations facility in Duvvada, Visakhapatnam with zero critical and six major observations," Dr Reddy's Labs said in a filing to BSE.

September 08, 2017 / 12:31 PM IST
Aurobindo Pharma Ltd.

Aurobindo Pharma Ltd.

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Dr Reddy's Laboratories (DRL) today said the German drug regulator has concluded the audit of its Visakhapatnam formulations facility with six major observations.

"The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit of our formulations facility in Duvvada, Visakhapatnam with zero critical and six major observations," Dr Reddy's Labs said in a filing to BSE.

It said the products manufactured at the facility are currently not 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," it added.

The facility's compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of EU-GMP certification.

Shares of Dr Reddy's Labs were today trading at Rs 2,157.10 per scrip on BSE, down 3.01 per cent from previous close.

first published: Sep 8, 2017 12:25 pm

Discover the latest business news, Sensex, and Nifty updates. Obtain Personal Finance insights, tax queries, and expert opinions on Moneycontrol or download the Moneycontrol App to stay updated!

Advisory Alert: It has come to our attention that certain individuals are representing themselves as affiliates of Moneycontrol and soliciting funds on the false promise of assured returns on their investments. We wish to reiterate that Moneycontrol does not solicit funds from investors and neither does it promise any assured returns. In case you are approached by anyone making such claims, please write to us at grievanceofficer@nw18.com or call on 02268882347