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Strides Receives US FDA EIR for Flagship Facility in Bengaluru

Strides Receives US FDA EIR for Flagship Facility in Bengaluru

Strides Pharma Science announced that its flagship manufacturing facility in Bengaluru has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA), indicating the successful closure of the inspection conducted at the facility.

The FDA had conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. As previously disclosed to the stock exchanges on May 20, 2026, the inspection concluded with the issuance of a Form 483 that contained 5 observations.

The company submitted a comprehensive response addressing all observations within the stipulated timeline.

Based on the company's response and the corrective and preventive actions implemented, the FDA has classified the inspection outcome as Voluntary Action Indicated (VAI) and has issued the EIR, thereby concluding the inspection.

The facility is Strides' flagship manufacturing site and serves regulated and other international markets. It manufactures a broad portfolio of pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting both existing commercial products and future growth opportunities.

The successful closure of the inspection further strengthens Strides' regulatory track record and reinforces the company's commitment to supplying high-quality pharmaceutical products to patients across global markets.

More news about: regulation | Published by News Bureau | August - 20 - 2026

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