United States Food and Drug Administration (USFDA) has completed a routine current Good Manufacturing Practices (cGMP) inspection at Strides Pharma Science’s wholly owned subsidiary -- Strides Alathur’s Chennai formulations facility. The inspection was conducted from April 1, 2024 to April 5, 2024.
The inspection closed with two observations. The company will respond to these observations comprehensively to FDA 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.