Granules India announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA). The inspection, carried out between July 28 and August 1, 2025, was the facility’s first FDA audit.
The receipt of the EIR confirms that the Hyderabad-based site complies with all applicable FDA quality and regulatory standards. This marks an important milestone for GLS, which is involved in manufacturing Pharmaceutical Formulation Intermediates (PFI) and finished dosage products.
In the exchange filings, the company shared, “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 approval strengthens the company’s global regulatory standing and supports its plans to expand international market opportunities.
