Strides Pharma Science announced that Strides Pharma Inc. (SPI), a step-down wholly owned subsidiary of the Company in the USA, has received the USFDA Inspection Closure Report (Establishment Inspection Report – EIR) for its Formulations Facility located at Chestnut Ridge, New York, USA.
The Facility was inspected by the United States Food and Drug Administration (USFDA) from 17 December 2025 to 23 December 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 Ac on 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. |