Bengaluru: Strides Pharma Science Limited (Strides) today announced that its flagship manufacturing facility in Bengaluru has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), marking the successful closure of the inspection conducted at the facility.
The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. The inspection concluded with the issuance of a Form 483 containing five observations. Strides subsequently submitted a comprehensive response addressing all observations within the stipulated timeline.
Following its review of the Company’s response and the corrective and preventive actions implemented, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and issued the EIR, thereby concluding the inspection.
The Bengaluru facility is Strides’ flagship manufacturing site and supplies regulated and other international markets. It manufactures a broad portfolio of pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting the Company’s existing commercial portfolio as well as future growth opportunities.
The successful closure of the inspection further strengthens Strides’ regulatory track record and reflects its continued focus on maintaining robust manufacturing and quality standards.
The development also reinforces Strides’ commitment to supplying high-quality pharmaceutical products to patients across global markets while supporting the Company’s growth across regulated international markets.
