Impact Analyses - Dr Reddy's Srikakulam Facility Observations

Dr. Reddy’s Laboratories Limited operates the CTO-SEZ Process Unit-01 located at Devunipalavalasa Village, Ranastalam Mandal, Srikakulam, Andhra Pradesh 532409, India (IND). The facility was inspected by the USFDA from December 4 to December 12, 2025, as part of a Pre- Approval Inspection (PAI), and the inspection concluded with the issuance of a Form 483 containing five observations.  

• The site is a strategically important manufacturing facility within Dr. Reddy’s U.S. generics network, supporting multiple high-value molecules and contributing company’s overall U.S. business. • The Srikakulam PU01 facility manufactures several important U.S.-marketed products, with annual sales > $ 5 million.
• Four out of the five important products have backup manufacturing facilities, materially lowering dependency on the Srikakulam site.
• More than 60% of the sales exposure linked to this facility is already backed up, mitigating the risk of sustained revenue disruption.
• In case of any supply disruptions due to GMP issues, we believe one drug which may face risk of shortages, driven by its relatively higher market share and the absence of an approved backup manufacturing facility.

 In conclusion, strong product-level backup coverage and a proven regulatory recovery track record are expected to limit business impact, provided timely corrective actions are implemented to address the five Form 483 observations.