NEW DELHI, Feb 5: Strides Pharma Science Ltd on Thursday said its arm Strides Pharma Inc (SPI) has received establishment inspection report from the US health regulator for its formulations unit at Chestnut Ridge in New York classifying the facility as voluntary action indicated.
The facility was inspected by the United States Food and Drug Administration (USFDA) 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, covering the company’s recent filing in nasal sprays domain, Strides Pharma Science said in a regulatory filing.
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 action indicated). The EIR states that the inspection has been closed, it added.
Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.
Strides Pharma said the Chestnut Ridge facility caters to the US market and manufactures liquids, gels, hormones, modified release products and controlled substances, supporting several current and future products for the US market.
The successful closure of this inspection including device combinations further strengthens the company’s US business and near term growth prospects, it added. (PTI)
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