Granules India Limited, a leading pharmaceutical manufacturing company, has announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its API Unit-| 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.

There was one observation during that inspection, and the Company had submitted its response within the stipulated time.

"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," said Dr. Krishna Prasad Chigurupati, Chairman & Managing Director.

This facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume. Along with Paracetamol APIs, the Company has established Metformin and Guaifenesin API manufacturing plants in the same facility.

The company remains dedicated to producing top-quality pharmaceutical products that meet global health standards.