Strides Pharma Inc. has received an Establishment Inspection Report (EIR) from the USFDA, clearing its formulations facility in Chestnut Ridge, New York. The inspection, which included Drug Device Combinations, covered manufacturing practices and a pre-approval inspection for Nasal Sprays. The USFDA classified the outcome as Voluntary Action Indicated (VAI), signaling the closure of the inspection.
USFDA Clears Chestnut Ridge Facility
Strides Pharma Inc. (SPI), a subsidiary of Strides Pharma Science Limited, has received the USFDA Inspection Closure Report (EIR) for its formulations facility located in Chestnut Ridge, New York, USA. This announcement was made on February 5, 2026.
Inspection Details and Outcome
The USFDA inspected the facility 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, particularly focusing on the Company’s filing in the Nasal Sprays domain.
Based on SPI’s response to the Form 483 issued after the inspection, the USFDA classified the outcome as Voluntary Action Indicated (VAI). The EIR confirms the closure of the inspection.
Facility Significance
The Chestnut Ridge facility caters to the U.S. market, manufacturing products such as Liquids, Gels, Hormones, Modified Release products, and Controlled Substances. The successful closure of this inspection, including Device Combinations, is expected to strengthen the Company’s U.S. business and near-term growth prospects.
Company Focus
Strides remains committed to upholding high standards of regulatory compliance and manufacturing high-quality pharmaceutical products for global markets.
Source: BSE
