Strides Pharma has informed exchanges about the successful completion of a routine current Good Manufacturing Practices (cGMP) inspection conducted by the United States Food and Drug Administration (USFDA) at its formulations facility in the United States.
The inspection was carried out at the Chestnut Ridge, New York facility of Strides Pharma Inc. USA, a step-down wholly owned subsidiary of the company, during the period from December 17 to December 23, 2025. At the end of the inspection, the USFDA issued a Form 483 with four observations.
According to the company, the observations raised by the regulator are procedural in nature and are not expected to have any impact on the supply of its commercial products. Strides Pharma clarified that manufacturing operations and product availability for the US market remain unaffected following the inspection outcome.
The company further stated that Strides Pharma Inc. USA will submit a comprehensive response to the USFDA within the stipulated timeline and is confident of addressing all the observations to the regulator’s satisfaction. Management emphasized that such observations are part of routine regulatory oversight and do not indicate any major compliance issues.
