Granules India Subsidiary Gains First U.S. FDA Approval for Hyderabad Facility
Filing Summary
Granules India Limited announced that its subsidiary, Granules Life Sciences Private Limited, received its first U.S. FDA approval for a product manufactured at its Hyderabad facility. The approval follows a Pre-Approval Inspection conducted in July 2025. This milestone enables Granules India to expand its finished dosage manufacturing capabilities. The company plans to launch the approved product in the U.S. market, where it is already produced at another facility. This development supports multi-site manufacturing and strengthens market presence.
Granules India Limited has reported that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has received approval from the U.S. Food and Drug Administration (FDA) for a product manufactured at its Hyderabad facility. The approval follows a Pre-Approval Inspection (PAI) conducted from July 28 to August 1, 2025. During this inspection, one observation was noted, and GLS submitted a response within the required timeframe. This marks the first FDA approval for the GLS site, enhancing Granules India’s finished dosage manufacturing capabilities.
The financial terms related to this approval were not disclosed in the filing. However, the approval is significant as it allows Granules India to introduce the product into the U.S. market. The product is already approved and manufactured at the company’s Gagillapur facility. This dual-site manufacturing capability is expected to support business continuity and market share expansion. The company has not specified the financial impact or revenue expectations from this approval.
The scope of this approval includes the manufacturing of a product that has already been approved at another facility. This strategic move enables Granules India to leverage its existing manufacturing infrastructure to meet market demands. The company has indicated plans to launch the product in the U.S. market soon, although specific timelines for the launch were not provided. The approval also positions the company to potentially file additional products from the GLS site, pending further audits and approvals.
Granules India operates in a competitive pharmaceutical market, with a focus on manufacturing Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). The company distributes its products to over 300 customers across more than 80 countries. The FDA approval for the GLS facility aligns with the company’s strategy to enhance its manufacturing capabilities and expand its presence in regulated markets.
The timeline for the product launch in the U.S. market has not been explicitly stated. However, the company has expressed intentions to proceed with the launch soon. The approval process involved a Pre-Approval Inspection by the FDA, which was completed in early August 2025. The GLS facility, located in Hyderabad, is now deemed approved by the FDA, marking a significant milestone for Granules India.
Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad. It is involved in the manufacturing of APIs, PFIs, and FDs. The company operates 10 manufacturing facilities, with eight located in India and two in the USA. Granules India is committed to operational excellence and quality, distributing its products globally to regulated and semi-regulated markets.