Jubilant Cadista Pharmaceuticals Inc., the US subsidiary of Jubilant Life Sciences Ltd, a global pharmaceutical and life sciences company, has received approvals from the US Food and Drug Administration (FDA) for escitalopram tablets USP, 5mg, 10mg and 20mg, olanzapine orally disintegrating tablet 5mg, 10mg, 15 mg and 20mg, losartan potassium tablets USP, 25 mg, 50mg and 100 mg and losartan potassium and hydrochlorothiazide tablets USP,50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg.
Commenting on the approval, Shyam S Bhartia, chairman & MD and Hari S Bhartia, co-chairman and MD, Jubilant Life Sciences said, “The recent US FDA approvals for four oral 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 & maintenance treatment of major depressive disorders with its branded version, LEXAPRO enjoying a market size of about US$ 2.7 billion. Further, Jubilant’s dossier and ANDA applications for this drug are pending for approval in EU and a few ROW countries.
Olanzapine ODT is a bioequivalent generic version of ZYPREXA ZYDIS Orally Disintegrating Tablets indicated for the treatment of schizophrenia and for the short term treatment of acute manic or mixed episodes associated with Bipolar I disorder. Annual US sales of the generic version are more than US$ 350 million. It has already been commercially launched in Europe and some other Emerging Markets by Jubilant.
Losartan Potassium is a potent, highly specific angiotensin receptor blocker (ARB).It is desirable for an effective treatment of hypertension and also lowers the chance of stroke in patients with high blood pressure and heart problem called left ventricular hypertrophy. It can also be used to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have/had high blood pressure. Annual sales of the branded version, COZAAR are approximately US$ 940 million.
Losartan Potassium and Hydrochlorothiazide Tablets is a combination of ARB and a diuretic. Annual sales for the branded drug HYZAAR is approximately US$ 670 million. Jubilant has already launched generic versions of both in Europe and the two filings are awaiting approval in few other markets.
Escitalopram and Olanzapine ODT would be manufactured in Jubilant’s dosage formulations facility at Roorkee, India. Losartan Potassium and its variant would be manufactured at the facility in Maryland, USA.
Jubilant Life Sciences Limited is engaged in manufacture and supply of APIs, generics, specialty pharmaceuticals and life science ingredients.