Strides Pharma Science Limited announced that its step-down wholly owned US subsidiary, Strides Pharma Inc. (SPI), has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration for its formulations manufacturing facility located at Chestnut Ridge, New York. The EIR confirms that the USFDA inspection has been officially closed, marking a key regulatory milestone for the company’s US operations.
The USFDA inspection was conducted between December 17, 2025 and December 23, 2025, and covered compliance with current Good Manufacturing Practices. The review also included a pre-approval inspection focused on drug–device combination capabilities, specifically related to Strides’ recent filings in the nasal sprays segment. Following the inspection, the USFDA issued a Form 483, to which SPI submitted its responses within the stipulated timelines.
Based on the responses provided by Strides Pharma Inc., the USFDA has classified the inspection outcome as VAI, or Voluntary Action Indicated. The VAI classification indicates that while observations were noted, they do not warrant regulatory enforcement action, and the agency is satisfied with the corrective measures proposed. The issuance of the EIR and confirmation of inspection closure removes a key regulatory overhang for the facility.
The Chestnut Ridge manufacturing unit plays a strategic role in Strides’ US business. The facility supplies the US market and manufactures a wide range of dosage forms, including liquids, gels, hormones, modified-release products, and controlled substances. It also supports multiple ongoing and upcoming product launches targeted at the US pharmaceutical market.
Importantly, the successful closure of the inspection, including the assessment of drug–device combination capabilities, further strengthens Strides’ position in complex and differentiated product categories such as nasal sprays. This development is expected to support the company’s near-term growth prospects in the US, particularly in specialty and complex generics.
