Strides Pharma Gets USFDA EIR for New York Plant, Inspection Closed With VAI
New Delhi: Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Inc., has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its formulations manufacturing facility located in Chestnut Ridge, New York.
According to the company, the facility underwent an inspection conducted by the USFDA from December 17, 2025, to December 23, 2025. The inspection evaluated compliance with current Good Manufacturing Practices (cGMP) and also included a pre-approval inspection for Drug-Device Combination capabilities. The inspection specifically covered the company’s recent regulatory filing in the nasal sprays segment.
Following the inspection, the USFDA reviewed the subsidiary’s response to the observations issued under Form 483 at the conclusion of the inspection. Based on this response, the regulator classified the inspection outcome as Voluntary Action Indicated (VAI), and the EIR confirmed that the inspection has been successfully closed.
The Chestnut Ridge facility primarily caters to the United States market and is involved in the manufacturing of multiple dosage forms, including liquids, gels, hormone-based products, modified-release formulations, and controlled substances. The facility supports both existing commercial products and upcoming launches targeted at the US pharmaceutical market. The successful closure of the inspection, including the assessment of device combination capabilities, is expected to strengthen the company’s US business and support its near-term growth outlook.
Strides stated that it remains committed to maintaining high regulatory compliance standards and continues to focus on producing high-quality pharmaceutical products for global markets.
Headquartered in Bengaluru, Strides operates as a global pharmaceutical company with listings on Indian stock exchanges. The company primarily operates in regulated markets and follows an “in Africa for Africa” strategy while also maintaining an institutional business catering to donor-funded markets. Its manufacturing network spans multiple global locations, including Chennai, Puducherry, two facilities in Bengaluru, Milan in Italy, Nairobi in Kenya, and New York in the United States. The company focuses on developing complex and difficult-to-manufacture pharmaceutical products that are marketed in more than 100 countries worldwide, according to a press release issued by Strides Pharma Science Limited.
