US Food and Drug Administration (USFDA) has successful completed an inspection at Strides Pharma Science’s formulation facility at Alathur (Chennai) with Zero 483 observations. This is the second consecutive Zero 483 inspection for the site.
The current inspection was a Pre?Approval Inspection for sustained release class of drugs which is a new dosage format for the facility and is one of the focus areas for the company in the global markets. The facility recently completed a significant capacity expansion which will support the growth momentum for the US business.
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.
