Strides Pharma Science Ltd announced this week that the US Food and Drug Administration (FDA) has issued an establishment inspection report (EIR) for its Puducherry manufacturing facility. The US Food and Drug Administration issues an EIR upon the completion of an inspection of a facility under FDA or FDA-contracted scrutiny.
Strides Pharma Science said in a regulatory filing that the US Food and Drug Administration (US FDA) has closed the inspection conducted between February 20-24, 2023, and has classified the facility from official action indicated (OAI) to voluntary action indicated (VAI).
According to the company, it has received an EIR from the US FDA. Previously, the US FDA classified Strides' Puducherry facility as OAI in May 2019, followed by a warning letter in July 2019.
The Puducherry facility produces finished dosage formulation products in multiple dosage formats for the US, other regulated markets, and institutional businesses.
"As a result of the USFDA's reclassification, the filed abbreviated new drug applications (ANDAs) from this facility will now begin receiving approvals," the company said.