Strides Pharma Science has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Puducherry manufacturing facility (Facility), stating the inspection conducted between February 20, 2023 - February 24, 2023 has been closed. The USFDA has classified the facility from Official Action Indicated (OAI) to Voluntary Action Indicated (VAI).
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019. Strides Puducherry facility caters to the U.S., other regulated markets, and institutional businesses and produces finished dosage formulation products across multiple dosage formats. Consequent to this reclassification by the USFDA, the filed ANDAs from this facility will now start receiving approvals.
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.
