Hyderabad: Granules India Limited, a prominent pharmaceutical manufacturer, has announced the successful receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-| facility located in Bonthapally, Hyderabad. The inspection, conducted in June 2025, concluded with a classification of ‘Voluntary Action Indicated’ (VAI), reflecting the company’s adherence to global regulatory standards.
The inspection yielded one observation, to which Granules India responded within the stipulated timeframe. The FDA’s issuance of the EIR with a VAI classification confirms the facility’s compliance with essential quality and safety protocols.
Commenting on the development, Chairman and Managing Director Krishna Prasad Chigurupati stated, “The successful completion of this US FDA inspection and the subsequent receipt of the EIR with a satisfactory VAI classification reflects our commitment to maintaining the highest quality standards in our manufacturing operations.”
The Bonthapally facility is recognized as one of the world’s largest single-site Paracetamol API manufacturing plants by volume. In addition to Paracetamol, the site also houses production units for Metformin and Guaifenesin APIs, further strengthening Granules India’s position in the global pharmaceutical supply chain.
This milestone reinforces the company’s dedication to producing high-quality pharmaceutical ingredients that meet international health standards. Granules India continues to invest in regulatory excellence and operational integrity to support its mission of delivering safe and effective medicines worldwide.
