Hyderabad, Nov. 12 -- Granules India Limited, on Tuesday announced that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), located here, has received U.S. Food and Drug Administration (FDA) approval for a product that was the subject of a Pre-Approval Inspection (PAI) conducted between July 28 and August 1.
There was one observation during that inspection, and the GLS had submitted its response within the stipulated time.
With this approval, the GLS facility is now deemed approved by the U.S. FDA, marking a major milestone for Granules India as it expands its finished dosage manufacturing capabilities. This is the first FDA approval for the GLS site, the Hyderabad pharma said in a release here.
The company plans t...