Strides completes US FDA inspection at its Alathur facility
The company announced a successful completion of inspection at the facility by US FDA with “Zero 483 observations”
Strides Pharma Science recently announced that its formulation facility at Alathur, Chennai, India underwent a US FDA inspection starting August 05, 2019 and the inspection concluded with “Zero 483 observations”.
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 per cent to take full management and operational control of this manufacturing facility.
The facility recently completed a capacity expansion which will support the growth momentum for the US business and will solve for near term capacity issues due to the ongoing remediation at the Puducherry facility.