United States Food and Drug Administration (USFDA) has concluded a routine current Good Manufacturing Practices (cGMP) inspection at Strides Pharma Science’s Formulations Facility at Alathur, Chennai. The inspection was conducted from September 2, 2026 to September 11, 2026.
At the conclusion of the inspection, the USFDA has issued a Form 483 with three observations. The company will respond to these observations to USFDA within the stipulated time.
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.
