Granules gets FDA nod for allergy treatment drug

Hyderabad: 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.

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.

Recently, the company announced its intention to divest its entire equity shareholding in Granules Biocause Pharmaceuticals Co. Ltd. by selling its stake to joint venture partner.

Granules Biocause Pharmaceuticals Co. Ltd. is an equal joint venture between GIL and Hubei Biocause Heilen Pharmaceutical Co. Ltd. The manufacturing facility of the joint venture is in Jingmen, China.

The Hyderabad-headquartered, Granules India formed the joint venture in 2007 to ensure a regular supply of Ibuprofen API to support its requirements for manufacturing Pharmaceutical Formulation Intermediates and Finished Dosages.