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Strides Pharma Science has announced that its flagship manufacturing facility in Bengaluru, India, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), indicating the 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. As previously disclosed to the stock exchanges on May 20, 2026, the inspection concluded with the issuance of a Form 483 containing five observations. The company submitted a response addressing all observations within the stipulated timeline.
Based on 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 Establishment Inspection Report (EIR), thereby concluding the inspection.
The facility is Strides’ flagship manufacturing site and serves regulated and other international markets. The facility manufactures pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting existing commercial products and future growth opportunities.
The closure of the inspection further strengthens Strides’ regulatory track record and reinforces the company’s commitment to supplying pharmaceutical products to patients across global markets.
The post Strides Pharma receives USFDA EIR for Bengaluru facility appeared first on Express Pharma.
Strides Pharma receives USFDA EIR for Bengaluru facility | PharmaVoice