Granules Pharmaceuticals Receives Positive USFDA Report

Granules India Ltd. announced that the USFDA has issued an Establishment Inspection Report (EIR) for Granules Pharmaceuticals, Inc., a wholly-owned subsidiary of Granules India Ltd. in Chantilly, Virginia. The report was issued after a Pre-Approval Inspection (PAI) held in June 2025.

The inspection was performed as a result of Granules’ first-to-file Abbreviated New Drug Application (ANDA) for a controlled substance, which is the company’s path-breaking move in its expansion of the U.S. pharmaceutical market.

As part of the PAI, the USFDA identified only one observation in the Granules response. After it was contacted by the Granules team, the observation was resolved. This finding's resolution evidences the company's compliance framework, manufacturing operations, and their commitment to regulatory standards of the US market.

The commendable check by USFDA is a prerequisite for the controlled substance ANDA first-to-file with final approval, and thus enhancing the company's presence in these regulated markets aligns with the secured strategy.

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Granules on the other hand, given the authorization, propels itself to promote the availability of quality medications at an affordable price in the U.S. market as well, thereby, solidifying its global stature as a reliable pharmaceutical manufacturer.

Granules achieving the USFDA inspection culminated in the issuance of a clean EIR, thereby proving the company’s resolve toward regulatory excellence, operational integrity, and the manufacture of quality drugs for patient needs.

The controlled substance segment expansion will provide this company with prospects for growth and long-lasting regional value generation within the rigorous U.S. pharmaceutical landscape.