USFDA clears Strides’ manufacturing unit in Bengaluru

Account subscription benefits alongside Premium Stories, Editorials, Opinions and more. Unlock these with Subscription

Strides Pharma Science Limited on Thursday said its flagship manufacturing facility in Bengaluru has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), marking the successful closure of the regulatory inspection.

The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility between May 12 and May 20, 2026. The inspection concluded with the issuance of a Form 483, containing five observations.

Strides said it submitted a comprehensive response to the observations within the stipulated timeline and implemented corrective and preventive actions (CAPAs) to address the issues raised.

After assessing the company’s response and the actions taken, 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 caters to regulated and other international markets. It manufactures a wide range of pharmaceutical dosage forms, including tablets, capsules and oral liquids.

According to the company, the facility supports both existing commercial products and future growth opportunities across its international markets.

business (general) / pharmaceutical / medicine / health / manufacturing and engineering

Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.

We have migrated to a new commenting platform. If you are already a registered user of The Hindu and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.