Jubilant Life Sciences, an integrated pharmaceuticals and life sciences company, has received final ANDA approval from US FDA for irbesartan tablets USP, 75 mg, 150 mg and 300mg, and cetirizine hydrochloride tablets (chewable), 5 mg and 10 mg.
Irbesartan tablets USP is the genric versino of Avapro (Sanofi-Aventis), which is used for treating hypertension and nephropathy in type II diabetic patients. The total market size for irbesartan as per IMS is approximately $50 million per annum.
Cetirizine Hydrochloride tablets is the generic version of Zyrtec chewable tablets (Mcneil), used as an anti-histamine for the treatment of allergies.
Jubilant has filed total 781 formulation products up to the end of December 2014 of which 333 have been approved in various regions globally. This includes 72 ANDas filed in the US, of which 35 have been approved and 46 dossier filings in Europe. So far, it has received 9 ANDA approval during FY2015.