Granules India completes USFDA inspection for Bonthapally facility with one observation
Granules India Ltd's Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plant by volume.
New Delhi: Drug firm Granules India Ltd. said it has received one observation from the US health regulator following an inspection conducted at the firm's Bonthapally facility located at Hyderabad, Telangana.
The USFDA inspection at the facility was conducted from 22nd July 2019 to 261h July 2019.
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. The Company has already received approval from USFDA for Metformin API from this facility.
"Granules India Ltd's Bonthapally facility located at Hyderabad, Telangana, India has completed the US FDA inspection from 22nd July 2019 to 26th July 2019 with one(1) 483 observation," Granules said in a BSE filing.
Based in Hyderabad, Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets. The company was formed in 1984 as Triton Laboratories. Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad.
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