Strides Pharma Inc. has received the USFDA’s Establishment Inspection Report (EIR) for its Chestnut Ridge, New York, formulations facility. The inspection, conducted in December 2025, covered Good Manufacturing Practices and included Drug-Device Combination capabilities. The USFDA classified the inspection outcome as Voluntary Action Indicated (VAI), confirming closure. This clearance strengthens Strides’ U.S. business prospects.
USFDA Clearance for Chestnut Ridge
Strides Pharma Science Limited announced that its subsidiary, Strides Pharma Inc. (SPI), received the USFDA Inspection Closure Report (EIR) for its formulations facility at Chestnut Ridge, New York. This signifies the successful closure of the USFDA inspection.
Inspection Details
The USFDA inspection took place from December 17, 2025 to December 23, 2025. The inspection scope included current Good Manufacturing Practices (cGMP) and a pre-approval inspection for Drug-Device Combination capabilities, relating to the company’s recent Nasal Sprays domain filing.
Inspection Outcome
The USFDA has classified the outcome of the inspection as Voluntary Action Indicated (VAI), based on SPI’s response to the Form 483. The EIR confirms that the inspection has been officially closed.
Facility Impact
The Chestnut Ridge facility caters to the U.S. market, producing Liquids, Gels, Hormones, Modified Release products and Controlled Substances. This USFDA clearance is expected to bolster the company’s U.S. business and contribute to near-term growth.
Company Focus
Strides remains dedicated to maintaining high standards of regulatory compliance and producing high-quality pharmaceutical products for global markets.
Source: BSE
