Granules India Limited, a leading pharmaceutical manufacturing company, has announced that it received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-I facility located at Bonthapally, Hyderabad. The inspection, conducted in June 2025, concluded with a Voluntary Action Indicated (VAI) classification, signifying that the facility meets FDA’s quality and compliance standards.
The inspection resulted in one observation, to which the company promptly submitted its response within the stipulated timeframe. Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India, said that the successful completion of the FDA inspection underscores the company’s commitment to maintaining world-class quality and regulatory standards.
The Bonthapally facility is recognized as one of the world’s largest single-site Paracetamol API manufacturing plants by volume, and it also houses production units for Metformin and Guaifenesin APIs. Granules India continues to focus on delivering high-quality pharmaceutical products that adhere to global healthcare standards.
