The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) following the FDA inspection conducted in June 2025. The company reported one observation during the inspection and confirmed that it had submitted its response within the stipulated timeframe.
The company stated that this facility is one of the world’s largest single-site Paracetamol API manufacturing plants by volume. In addition to Paracetamol APIs, Granules India has also established Metformin and Guaifenesin API manufacturing plants at the same facility. The company remains committed to producing high-quality pharmaceutical products that meet global health standards.
Dr Krishna Prasad Chigurupati, chairman & managing director, said, "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."
Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).
The company’s consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25.