Granules India gets EIR from USFDA for Paracetamol, Metformin API manufacturing plant

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

New Delhi: Granules India has recently been issued an Establishment Inspection Report (EIR) by the US health regulator for Bonthapally facility located at Hyderabad, Telangana.

The facility was inspected by the United States Food and Drug Administration (USFDA) in July 2019 and was issued one (1) 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 Granules India has established Metformin and Guaifenesin API manufacturing plants in the same facility.

Granules India was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad. The company manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets.

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