Stride Pharma's Chennai Win: FDA Green Light!

Strides Pharma Science Limited announced today that its subsidiary, Strides Alathur Private Limited, has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its formulations facility in Alathur, Chennai. The approval follows a successful Good Manufacturing Practices (GMP) inspection conducted from April 1 to April 5, 2024.

The inspection resulted in a "Voluntary Action Indicated" (VAI) classification, indicating minor issues that the company is addressing voluntarily. The facility specializes in the production of tablets and capsules for the U.S. and other regulated markets, positioning it as a crucial asset in Strides Pharma's expanding product portfolio.

This FDA approval is a significant milestone for Strides Pharma, reinforcing the company's commitment to maintaining high standards of quality and compliance in its manufacturing processes. It also bolsters Strides' ability to serve the lucrative U.S. market, where demand for pharmaceuticals continues to rise.

Despite the positive development, Strides Pharma's stock showed a slight decline, trading at ₹1,298.15 on Monday, down ₹14.70 or 1.12% on the NSE. Investors are closely monitoring the company's next steps following this key regulatory approval.

News by Rahul Yelligetti