Hyderabad: Granules Life Sciences Private Limited (GLS), a wholly owned subsidiary of Granules India Limited, has received its first approval from the United States Food and Drug Administration (U.S. FDA) for its Hyderabad-based manufacturing facility. The authorization follows a Pre-Approval Inspection (PAI) carried out by FDA officials between July 28 and August 1, 2025, and marks a key regulatory milestone for the company’s expansion in the U.S. pharmaceutical market.
According to company filings and public disclosures, the inspection of the Hyderabad facility concluded with a single observation, which was promptly addressed by Granules Life Sciences within the stipulated timeline. The successful closure of the inspection and the subsequent approval confirm that the plant meets all standards set under the U.S. FDA’s Current Good Manufacturing Practices (CGMP) framework as outlined in Title 21 of the Code of Federal Regulations.
The PAI is one of the most important steps before any overseas facility can manufacture products for sale in the United States. It involves a detailed assessment of the plant’s quality systems, production methods, documentation practices, and overall compliance. The successful outcome of this inspection now enables the Hyderabad site to legally produce and export finished dosage forms to the U.S. market. This development makes the Hyderabad site the second Granules India facility to receive FDA clearance for the same product, after the company’s Gagillapur unit. With both facilities now approved, Granules India will be able to increase production capacity, reduce supply chain risk, and strengthen its market presence through dual-site manufacturing.
Compliance and Legal Framework
The approval has significant regulatory and operational implications under the Federal Food, Drug, and Cosmetic Act (FDCA). As per U.S. law, any drug marketed in the country must be produced at a facility inspected and approved by the FDA. The clearance for the Hyderabad unit ensures Granules Life Sciences can legally manufacture and export its product to the U.S., provided that it continues to adhere to all applicable compliance standards.
The inspection and approval process are also in line with international harmonization initiatives under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Both frameworks aim to unify regulatory standards across member countries, easing cross-border approvals for companies that maintain consistent quality and compliance.
In its filing with the Bombay Stock Exchange (BSE) dated November 11, 2025, Granules India stated that the U.S. FDA approval supports its strategy to expand finished dosage manufacturing capacity and underscores its commitment to maintaining the highest regulatory standards. The company highlighted that having two U.S.-approved facilities will provide business continuity, ensure product availability, and mitigate potential operational disruptions.
With this approval, Granules Life Sciences plans to begin production and market rollout of the approved pharmaceutical product in the United States shortly. Although the specific product name has not been publicly disclosed, it is already manufactured and distributed from the company’s Gagillapur site. The newly approved Hyderabad facility will act as an additional hub to meet rising demand and ensure steady supply. The company expects the dual-site manufacturing model to contribute to revenue growth, operational resilience, and broader access to the U.S. generics market.
The U.S. remains one of the most competitive and highly regulated pharmaceutical markets worldwide. According to IQVIA data, the American generics segment was valued at approximately USD 74 billion in 2024, with high compliance standards that only established and regulation-focused companies can meet successfully.
Granules India’s Chairman and Managing Director, Krishna Prasad Chigurupati, said in a press statement that the company’s focus remains on strengthening its position through consistent regulatory performance and strategic manufacturing expansion. He added that the Hyderabad site’s approval reinforces Granules India’s long-term goal of increasing production capacity while maintaining quality assurance across all operations.
Strategic and Business Implications
The U.S. FDA’s authorization is expected to accelerate Granules India’s efforts to diversify its product portfolio and improve its supply reliability to global clients. With multiple sites now certified for U.S. export, the company is better positioned to manage capacity utilization, reduce dependency on a single facility, and optimize logistics for international shipments.
The approval also opens the pathway for Granules Life Sciences to file additional product applications under the Abbreviated New Drug Application (ANDA) route, subject to FDA review. Successful ANDA approvals would further enhance the company’s product offerings and market reach within the United States.
Following this development, the company will focus on the next operational steps, including coordination with U.S. distribution partners, production scheduling, and continuous engagement with regulatory bodies. Maintaining adherence to post-approval compliance requirements will remain a key focus area as Granules Life Sciences begins commercial operations for the U.S. market.
The U.S. FDA’s first approval for Granules Life Sciences’ Hyderabad facility represents a major achievement for the company and a critical step in its global expansion. The successful completion of the PAI and the facility’s compliance with all regulatory standards validate Granules’ manufacturing quality and operational systems. By securing this approval, Granules Life Sciences gains the legal authorization to manufacture and export pharmaceutical products from its Hyderabad unit to the U.S. market—strengthening both its regulatory credentials and its contribution to Granules India’s overall global supply framework.
