Strides Pharma Science Limited (Strides) announced that its formulation facility at Alathur (Chennai), India underwent a USFDA inspection which concluded 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 Alathur facility became part of the Strides manufacturing base in May 2017 after the Company entered into a 50:50 joint venture(JV) with Vivimed Labs. In March 2019, Strides converted its ownership in JV to 100% to take full management and operational control of this manufacturing facility. The facility recently completed a significant capacity expansion which will support the growth momentum for the US business.
