Strides Pharma Science Limited announced that its step-down wholly owned subsidiary in the USA, Strides Pharma Inc. (SPI), has received the U.S. Food and Drug Administration (USFDA) Inspection Closure Report (Establishment Inspection Report – EIR) for its formulations facility located at Chestnut Ridge, New York, USA. The inspection, which took place from December 17, 2025, to December 23, 2025, covered current Good Manufacturing Practices (cGMP) and a pre-approval inspection for Drug-Device Combination capabilities, including the company's recent filing in the Nasal Sprays domain. Following SPI's response to the Form 483 issued at the inspection's conclusion, the USFDA classified the outcome as Voluntary Action Indicated (VAI), indicating the closure of the inspection. The Chestnut Ridge facility, which serves the U.S. market, manufactures Liquids, Gels, Hormones, Modified Release products, and Controlled Substances. The successful closure of this inspection, particularly including Device Combinations, is expected to strengthen Strides' U.S. business and near-term growth prospects. The company remains committed to high regulatory compliance standards and the production of quality pharmaceutical products for global markets.
