Dr. Reddy’s Srikakulam Plant Clears USFDA Inspection With VAI Classification

Dr. Reddy’s Laboratories Ltd. ( (IN:DRREDDY) ) has provided an update.

Dr. Reddy’s Laboratories has received the Establishment Inspection Report from the U.S. Food and Drug Administration for its formulations manufacturing facility at Srikakulam in Andhra Pradesh, following a good manufacturing practice and pre-approval inspection conducted in December 2025. The inspection was classified as “Voluntary Action Indicated,” indicating that while some minor issues may have been noted, the regulator has closed the inspection, supporting the facility’s continued eligibility to supply products to the U.S. market and reinforcing the company’s regulatory compliance profile.

This outcome reduces the risk of major compliance-related disruptions at the Srikakulam site, which is important for sustaining U.S.-bound product launches and ongoing supplies. The closure of the inspection with a VAI classification is likely to be viewed positively by stakeholders, as it suggests that no significant enforcement action is anticipated and that the company can proceed with its operational and approval plans linked to this facility.

More about Dr. Reddy’s Laboratories Ltd.

Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company based in India, engaged in the development, manufacture and marketing of generic and branded formulations. The company supplies medicines to regulated markets including the U.S. and focuses on maintaining compliance with international quality and regulatory standards across its manufacturing network.

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