Granules India's key facility gets FDA approval

Granules India Limited, a pharmaceutical manufacturer, received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-I facility in Bonthapally, Hyderabad. The report, issued on October 29, 2025, classified the inspection as "Voluntary Action Indicated" (VAI) following an inspection conducted in June 2025. This classification indicates a satisfactory outcome despite one observation, for which the company had submitted a timely response.

The API Unit-I facility is notable for being one of the world's largest single-site Paracetamol API manufacturing plants by volume. In addition to Paracetamol, the facility also produces Metformin and Guaifenesin APIs. krishna prasad chigurupati, chairman & managing director, highlighted the VAI classification as a testament to the company's commitment to maintaining high-quality standards in its manufacturing operations.

Granules India Limited, incorporated in 1991, operates 10 manufacturing facilities, eight in India and two in the USA. The company serves over 300 customers in more than 80 countries, with regulatory approvals from various global bodies, including the US FDA and EU GMP.