Dr. Reddy’s Laboratories Ltd. (NSE: DRREDDY, BSE: 500124, NYSE: RDY) has announced that it received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. This development comes following the company’s prior intimation on June 7, 2024, regarding the inspection conducted by the USFDA at the site.
The USFDA has classified the inspection as “Voluntary Action Indicated” (VAI), a category that signifies that while certain objectionable conditions were found during the inspection, the company is not required to take immediate regulatory action. Importantly, the agency has deemed the inspection “closed” under the provisions of 21 CFR 20.64(d)(3), indicating that no further action is necessary at this time.
The classification of the inspection as VAI suggests that the company is expected to address the issues identified, but it does not anticipate any significant impact on ongoing production at the facility.
This update is in accordance with Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and has been submitted to the National Stock Exchange of India Ltd., BSE Limited, New York Stock Exchange Inc., and NSE IFSC Ltd.
Dr. Reddy’s Laboratories, a global pharmaceutical company, operates numerous manufacturing facilities, including the Srikakulam unit, which plays a crucial role in producing APIs for a range of its products.
