The United States Food and Drug Administration (USFDA) has conducted a routine current Good Manufacturing Practices (cGMP) inspection at the formulations facility of Strides Pharma Inc. USA (SPI), a step-down wholly owned subsidiary of Strides Pharma Science Limited, at Chestnut Ridge, New York, USA during the period December 17, 2025 to December 23, 2025. 

At the conclusion of the inspection, the U.S. FDA has issued a Form 483 with four observations. These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products. SPI will respond to these observations comprehensively to FDA within the stipulated time and is confident of addressing all the observations to the satisfaction of USFDA.