Granules India gets EIR from USFDA for API unit-I facility in Hyderabad

29 Oct 2025 Evaluate

Granules India has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its API Unit-I 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. 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. 

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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