Granules India gets 2 USFDA observations for Chantilly facility

"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US, on August 21, 2019, with two minor observations," Granules India said in a filing to BSE.

New Delhi: Drug firm Granules India on Thursday said the US health regulator has issued two observations after inspection of Chantilly facility of its American arm in Virginia.

"The United States Food and Drug Administration (USFDA) has completed inspection of the facility of Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US, on August 21, 2019, with two minor observations," Granules India said in a filing to BSE.

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This is a pre-approval inspection for seven products filed from this facility, it added.

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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