Full Press Release Details
National Stock Exchange of India Ltd. (Scrip Code:
BSE Limited (Scrip Code: 500124)
New York Stock Exchange Inc. (Stock Code: RDY)
NSE IFSC Ltd. (Stock Code: DRREDDY)
Sub: Intimation under Regulation 30 of the SEBI
(Listing Obligations and Disclosure Requirements) Regulations, 2015
In furtherance to our intimation dated October 12,
2023, on the Pre-Approval Inspection (PAI) at our Biologics manufacturing facility in Bachupally, Hyderabad, and our announcement dated
July 12, 2023, on the acceptance of the Biologics License Application (BLA) of our proposed biosimilar rituximab candidate DRL_RI, we
would like to inform you that the United States Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) to our
BLA. The CRL is in reference to ongoing resolution of observations arising from the inspection of our Biologics facility in October 2023,
as well as certain aspects pertaining to the BLA.
This has no impact on the development or manufacturing
of any current commercial or pipeline product.
We will continue to work closely with the USFDA to
address and resolve all concerns within stipulated timelines in order to make this biosimilar rituximab available to patients in the U.S.
as soon as possible.
This is for your information and records.
For Dr. Reddy's Laboratories Limited
Company Secretary, Compliance Officer & Head-CSR