Granules Life Sciences Completes US FDA Inspection with VAI Status

Granules India Limited reported that its wholly owned subsidiary, Granules Life Sciences Private Limited (GLS), has completed a US FDA inspection of its manufacturing facility located in Shamirpet, Telangana. The inspection concluded with a classification of Voluntary Action Indicated (VAI). This inspection, which took place from December 15 to 19, 2025, was part of a current Good Manufacturing Practice (cGMP) and pre-approval inspection (PAI) for oral solid dosage manufacturing operations.

The inspection resulted in the issuance of an Establishment Inspection Report (EIR), and no regulatory action has been recommended. This indicates compliance with the necessary regulatory standards set by the US FDA. The VAI classification allows the company to continue its manufacturing operations without any immediate corrective actions required.

The scope of the inspection covered the manufacturing processes for oral solid dosages at the Shamirpet facility. The inspection assessed the facility’s adherence to cGMP standards, which are crucial for ensuring the quality and safety of pharmaceutical products. This classification supports Granules India’s ability to manufacture approved products across multiple sites, enhancing its operational flexibility.

The inspection’s conclusion without any regulatory action is significant for Granules India’s business operations. It underscores the company’s compliance with international regulatory standards, which is essential for maintaining its market presence in regulated markets. The ability to conduct multi-site manufacturing for approved products is a strategic advantage for the company, allowing it to optimize its production capabilities.

The inspection was conducted over a five-day period in December 2025, and the results were communicated on March 31, 2026. The inspection’s closure without further regulatory requirements indicates that the facility meets the necessary standards for pharmaceutical manufacturing as per US FDA guidelines.

Granules India Limited is a vertically integrated pharmaceutical company involved in the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). The company operates 11 manufacturing facilities, with eight located in India, two in the USA, and one in Switzerland. Granules India is committed to maintaining high-quality standards across its operations, ensuring compliance with various international regulatory bodies.