Strides Pharma US arm receives closure report for Chest Ridge facility after USFDA inspection

Shares of Strides Pharma Science Ltd. are trading between gains and losses on Thursday, February 5, as the US drug regulator issued voluntary action indicated (VAI), under its inspection closure report, for the firm’s US-based step-down wholly-owned subsidiary’s formulations facility.The US Food and Drug Administration had inspected the subsidiary Strides Pharma Inc.’s facility at Chest Ridge, New York, US, from December 17, 2025 to December 23, 2025. The inspection covered current good manufacturing practices and included pre-approval inspection for drug device combination capabilities, covering the company’s recent filing in nasal sprays domain, Strides Pharma said.

Based on Strides Pharma Inc’s response to the Form 483, which was issued at the conclusion of the inspection, the USFDA classified the inspection outcome as VAI. The establishment inspection report (EIR) states that the inspection has been closed, the company 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, it said.Strides Pharma said the successful closure of the inspection, including device combinations, further strengthens the company’s US business and near-term growth prospects.

Shares of Strides Pharma are trading 0.7% lower on Thursday at ₹860. The stock is up 16% over the last 12 months.

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