Granules India’s Unit Secures US FDA EIR with 'Voluntary Action Indicated’ (VAI)

Granules India Limited, a leading pharmaceutical manufacturing company, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-1 facility located at Bonthapally, Hyderabad. The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025. The facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume, and it also has Metformin and Guaifenesin API manufacturing plants. The company remains dedicated to producing top-quality pharmaceutical products that meet global health standards.