United States Food and Drug Administration (USFDA) has concluded 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 at Chestnut Ridge, New York, USA. The inspection was conducted from December 17, 2025 to December 23, 2025.
At the conclusion of the inspection, the USFDA 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.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
