Jubilant Life US arm gets approval from USFDA for 4 drugs
The U.S.-based subsidiary of Jubilant Life Sciences Ltd namely Jubilant Cadista Pharmaceuticals., Inc has secured approvals from the U.S. Food and Drug Administration for four drugs. These include escitalpram tablets USP, 5mg, 10mg and 20mg, Olanzapine orally disintegrating tablet 5mg, 10mg, 15mg and 20 mg, Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg and Losartan Potassium and Hydrochlorothiazide tablets USP 50mg/12.5 mg, 100mg/12.5mg and 100mg/25mg.
Mr. Shyam S Bhartia, Chairman and Managing Director and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said, “The recent USFDA approvals for four solid dosage formulations reinforce our growth strategy through new product launches and further demonstrate our strength in vertical integration from in-house APIs to generics for cost competitive advantage.”
Escitalopram is used for acute treatment of generalized anxiety disorder and acute and maintenance treatment of major depressive disorders with its branded version, LEXAPRO®.
Another drug, Olanzapine ODT is a bioequivalent generic version of ZYPERXAZYDIS®. It is used to treat schizophrenia and also for short-term treatment of acute manic or mixed episodes associated with Bipolar I disorder.
Losartan Potassium is a potent, highly specific angiotensin receptor blocker. Losartan Potassium and Hydrochlorothiazide tablets are a combination of ARB and a diuretic.
Escitalopram and Olanzapine ODT would be manufactured in Jubilant’s dosage formulations facility at Roorkee, India. Jubilant Life Sciences is an integrated pharmaceutical and life sciences company. It is also the largest custom research and manufacturing services player.