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.
Also Read: Granules India gets EIR from USFDA for Paracetamol, Metformin API manufacturing plant
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.
Also Read: Granules India to exit from Chinese JV Granules Bio-cause
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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