Granules India has received an Establishment Inspection Report (EIR) from the US FDA for its API Unit-I facility in Bonthapally, Hyderabad, with a Voluntary Action Indicated (VAI) classification. The inspection, which took place in June 2025, resulted in one observation, to which the company responded promptly. The VAI classification demonstrates Granules India’s commitment to maintaining high-quality standards in its manufacturing processes.
FDA Inspection Outcome
Granules India Limited announced that the U.S. Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) for its API Unit-I facility located in Bonthapally, Hyderabad. The EIR follows an inspection conducted in June 2025, which concluded with a Voluntary Action Indicated (VAI) classification.
Voluntary Action Indicated (VAI)
The facility received a VAI classification, confirming that the FDA will not take further regulatory action based on the inspection findings. This outcome reflects Granules India’s adherence to quality and compliance standards. There was one observation noted during the inspection, to which Granules India responded within the set timeframe, resolving the concern to the FDA’s satisfaction.
Commitment to Quality Standards
According to Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, this successful inspection and the subsequent EIR with a satisfactory VAI classification underscores Granules India’s dedication to upholding the highest quality standards in its manufacturing operations.
Facility Overview
The Bonthapally facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume. The facility also manufactures Metformin and Guaifenesin APIs.
Granules India: An Overview
Granules India, established in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. It manufactures Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). The company serves over 300 customers in regulated and semi-regulated markets across 80+ countries, with manufacturing facilities in India and the US.
Source: BSE
