Granules India arm passes US FDA quality check for Hyderabad unit

Granules Life Sciences Private Limited (GLS), a wholly-owned subsidiary of Granules India Limited, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Hyderabad facility.

"Granules Life Sciences Private Limited (GLS), a wholly owned subsidiary of Granules India Limited situated in Hyderabad, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the first inspection conducted from July 28, 2025 to Aug 01, 2025. This approval confirms the facility's compliance with FDA quality standards and regulatory requirements," the company said in an exchange filing.

The inspection, conducted from July 28 to August 1, 2025, confirmed the facility's compliance with FDA quality standards and regulatory requirements. Granules Life Sciences Private Limited is engaged in the manufacturing of PFI and finished dosages.

Shares of Granules India ended 1.64% in the green on Friday, December 12.

In the September quarter, Granules India's net profit came in at ₹131 crore. Revenue rose 34.2% to ₹1,297 crore, while EBITDA increased 37% to ₹278 crore. 

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