USFDA classifies Strides Pharma’s Puducherry facility as Official Action Initiated
6th May 2019

Strides Pharma Science has received a communication from the United States Food & Drug Administration (USFDA) on May 04, 2019 classifying the Puducherry facility as Official Action Initiated (OAI) based on the inspection conducted from January 28- February 05, 2019.

The company believes that the classification will not have an impact on the current supplies and revenues from the facility. However, of the 34 ANDA’s pending approval, Puducherry has 10 ANDA’s where the company expects delays until the facility is reclassified.

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.