Strides Pharma Science’s step-down wholly owned subsidiary in USA -- Strides Pharma Inc. (SPI) has received the United States Food and Drug Administration (USFDA) Inspection Closure Report (Establishment Inspection Report - EIR) for its Formulations Facility located at Chestnut Ridge, New York. The Facility was inspected by the USFDA from December 17, 2025 to December 23, 2025. The inspection covered current Good Manufacturing Practices (cGMP) and included a pre-approval inspection for Drug-Device Combination capabilities, covering the company’s recent filing in Nasal Sprays domain.
Based on SPI’s response to the Form 483 that was issued at the conclusion of the inspection, the USFDA has classified the inspection outcome as VAI (Voluntary Action Indicated). The EIR states that the inspection has been closed. The Chestnut Ridge facility caters to the U.S. market and manufactures Liquids, Gels, Hormones, Modified Release products and Controlled Substances, supporting several current and future products for the U.S. market. The successful closure of this inspection including Device Combinations further strengthens the company’s U.S. business and near-term growth prospects.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
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