Wednesday, September 9, 2026

Granules India shares gain after US unit gets EIR from USFDA

Date:

Shares of Granules India Ltd. gained as much as 2% on Wednesday, June 3, after the company announced that its wholly owned subsidiary, Granules Pharmaceuticals Inc. (GPI), has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its facility in Chantilly, Virginia.The USFDA classified the inspection as Voluntary Action Indicated (VAI), indicating that while certain observations were made, they do not warrant any regulatory or enforcement action.


The inspection was conducted between March 30 and April 3, 2026, during which the regulator issued four observations in Form 483.In an exchange filing, Granules India said the Chantilly facility plays a key role in its global manufacturing and supply network, supporting the company’s focus on quality systems, regulatory compliance and patient safety.

The company added that it remains committed to maintaining the highest standards of quality, safety and regulatory compliance across its manufacturing facilities in both India and the US.

Granules India shares were trading 1.25% higher at ₹787.30 on Wednesday. The stock has gained more than 27% so far this year.

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