Strides Pharma Receives USFDA Closure Report for New York Facility
Filing Summary
Strides Pharma Science Limited announced that its subsidiary, Strides Pharma Inc., received a USFDA Establishment Inspection Report (EIR) for its formulations facility in Chestnut Ridge, New York. The inspection, conducted from December 17 to December 23, 2025, covered current Good Manufacturing Practices (cGMP) and included a pre-approval inspection for Drug-Device Combination capabilities, specifically in the Nasal Sprays domain. The USFDA classified the inspection outcome as Voluntary Action Indicated (VAI), confirming the closure of the inspection. The facility supports the U.S. market with various pharmaceutical products.
Strides Pharma Science Limited announced that its subsidiary, Strides Pharma Inc. (SPI), has received the USFDA Establishment Inspection Report (EIR) for its formulations facility located in Chestnut Ridge, New York. The inspection by the United States Food and Drug Administration (USFDA) took place from December 17 to December 23, 2025.
The inspection covered current Good Manufacturing Practices (cGMP) and included a pre-approval inspection for Drug-Device Combination capabilities. This inspection specifically addressed the company’s recent filing in the Nasal Sprays domain. Based on SPI’s response to the Form 483 issued at the conclusion of the inspection, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI). The EIR confirms that the inspection has been closed.
The Chestnut Ridge facility is designed to cater to the U.S. market and is involved in the manufacturing of various pharmaceutical products, including Liquids, Gels, Hormones, Modified Release products, and Controlled Substances. These products support several current and future offerings for the U.S. market.
Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bengaluru, India. It is listed on the BSE Limited and the National Stock Exchange of India Limited. The company primarily operates in regulated markets and follows an “in Africa for Africa” strategy, along with an institutional business to service donor-funded markets. Strides focuses on manufacturing complex pharmaceutical products sold in over 100 countries. Additional information is available on the company’s website.