Dr Reddy's gets extra time to respond to warning letter

November 27, 2015 | Friday | News | By BioSpectrum Bureau

Dr Reddy's gets extra time to respond to warning letter

The firm is in the process of preparing a response to the letter

The firm is in the process of preparing a response to the letter

Dr Reddy's Laboratories (DRL) has said that the US Food and Drug Administration (US FDA) has extended the time-frame for replying to the warning letter issued to the company by about two weeks to 7 December.

On November 5, 2015, the company has received a warning letter issued by the US health regulator 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.

Dr Reddy's is in the process of preparing a response to FDA's warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the Company's response to its warning letter.

 

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