Granules India gets USFDA nod for Fexofenadine Hydrochloride tablets to treat allergy symptoms

Granules India's Fexofenadine Hydrochloride tablets USP is bio-equivalent to the reference listed drug product (RLD), Allegra Allergy Tablets, 60 mg and 180 mg, of Sanofi-Aventis US LLC.

New Delhi: Drug firm Granules India on Monday said it has received approval from the US health regulator for Fexofenadine Hydrochloride tablets, used to treat allergy symptoms.

The approved product is bio-equivalent to the reference listed drug product (RLD), Allegra Allergy Tablets, 60 mg and 180 mg, of Sanofi-Aventis US LLC.

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The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules India for Fexofenadine Hydrochloride tablets USP in the strengths of 60 mg and 180 mg (OTC), Granules said in a regulatory filing.

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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