Last Updated on October 11, 2024 by The Health Master
New Delhi: Strides Pharma Science Ltd said it has received an establishment inspection report (EIR) from the US health regulator for its Puducherry manufacturing facility.
The US Food and Drug Administration issues an EIR on closure of inspection of an establishment that is the subject of an USFDA or USFDA-contracted scrutiny.
The US Food and Drug Administration (USFDA) 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), Strides Pharma Science said in a regulatory filing.
The company has received an EIR from the USFDA, it said. Earlier, the USFDA had classified Strides‘ Puducherry facility as OAI in May 2019, followed by issuing a warning letter to this site in July 2019.
The Puducherry facility caters to the US, 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 abbreviated new drug applications (ANDAs) from this facility will now start receiving approvals,” the company said.
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