Update on Dr Reddy's FDA warning letter

December 09, 2015 | Wednesday | News | By BioSpectrum Bureau

Update on Dr Reddy's FDA warning letter

Dr Reddy's has received a warning letter issued by the US FDA on November 05

Dr Reddy's has received a warning letter issued by the US FDA on November 05

Dr Reddy's Laboratories (DRL) has submitted a response to the US Food and Drug Administration (US FDA) on December 7, 2015, the firm said in a filing to BSE.

Dr Reddy's has received a warning letter issued by the US FDA on November 05, 2015 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.

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

 

Comments

× Your session has expired. Please click here to Sign-in or Sign-up

Have an Account?

Forgot your password?

First Name should not be empty!

Last Name should not be empty!

Email address should not be empty!

Show Password should not be empty!

Show Confirm Password should not be empty!

Newsletter

E-magazine

Biospectrum Infomercial

Bio Resource

I accept the terms & conditions & Privacy policy