Granules India Gets US FDA Nod for Hyderabad API Unit

Granules India increased 2.04% to Rs 581.15 after it disclosed that it had 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 EIR was issued with a Voluntary Action Indicated (VAI) inspection classification, according to the FDA Inspection conducted in June 2025. The company declared one observation during the inspection and asserted that it submitted its response per due dates.

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."

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The company also mentioned that this facility is one of the largest single-site Paracetamol API manufacturing plants in the world by volume. In addition to Paracetamol APIs, Granules India has now established Metformin and Guaifenesin API plants at the same facility. The company is committed to producing high-quality pharmaceutical products to responsibly provide access to medications to sustain global health.

Granules India primarily engages in the manufacturing and selling of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

Granules India's consolidated net income declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 versus Q2 FY25.