Moneycontrol Be a Pro
Get App
Last Updated : Dec 09, 2015 03:16 PM IST | Source: PTI

Dr Reddy's submits response to USFDA over warning letter

In response to the letter, DRL CEO G V Prasad had said the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants.

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Dr Reddy's Laboratories has submitted a response to the US health regulator on a warning letter it had received last month.

"We would like to inform that the company has submitted a response to the US Food and Drug Administration (USFDA) on December 7", Dr Reddy's Laboratories said in a filing to the BSE.

Last month, the country's second-largest drug maker had received a warning letter from the USFDA relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.

In response to the letter, DRL CEO G V Prasad had said the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants.

The US agency had asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data and include a detailed action plan to fully investigate the scale and root causes of "deficient documentation and data management practices".

Dr Reddy's Laboratories has submitted a response to the US health regulator on a warning letter it had received last month.

"We would like to inform that the company has submitted a response to the US Food and Drug Administration (USFDA) on December 7", Dr Reddy's Laboratories said in a filing to the BSE.




Are you happy with your current monthly income? Do you know you can double it without working extra hours or asking for a raise? Rahul Shah, one of the India's leading expert on wealth building, has created a strategy which makes it possible... in just a short few years. You can know his secrets in his FREE video series airing between 12th to 17th December. You can reserve your free seat here.
First Published on Dec 9, 2015 09:47 am
Loading...
Follow us on
Available On