USFDA issues EIR for Granules India’s Bonthapally facility in Hyderabad

US Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) for Granules India’s Bonthapally facility located at Hyderabad, Telangana, India.

This facility was inspected by USFDA in July 2019 and there was one observation during the inspection. Bonthapally facility is one of the world’s largest single site Paracetamol API manufacturing plant 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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