Ipca Labs, US-based Heritage to market cardiovascular tablet, Propranolol in the US
13 Oct 2008
Ipca Laboratories Ltd has entered into a an agreement with US-based Heritage Pharmaceuticals Inc, to manufacture Propranolol HCI oral tablets to be marketed by Heritage to the US healthcare system.
In August 2007 the two companies had agreed to work together where Ipca would develop and register selected products for US ANDA submissions for which Heritage would have sales and marketing rights with both companies sharing net profits from the sales proceeds post-launch.
Following its agreement with Heritage, in June this year Ipca obtained US FDA approval for its Piparia (Silvassa, Gujarat) formulations manufacturing unit after inspection by US FDA early this year, to manufacture and market Propranolol HCI in 10mg, 20mg, 40mg, 60mg and 80mg dosages in the US market, making the product Ipca's first product approval for from this production facility.
Propranolol tablet treats multiple cardiovascular related conditions, including the management of hypertension, treatment of angina and atrial fibrillation.
According to IMS Health , US brand and generic sales of Propranolol is approximately $25 million for the 12-month period ending 31 December 2007.
Ipca will manufacture and Heritage will market this formulation in the US healthcare system using Ipca's DMF approved active pharmaceutical ingredient (API) Propranolol. Heritage will commercialise this product in the US market utilising its established marketing and distribution network.
Ipca posted a net total income of Rs295.44 crore for the quarter ended 30 June 2008 as against Rs249.88 crore in the same quarter of the previous financial year, and boosted its' exports 40 per cent for the quarter to Rs152.52 crore, up from Rs109.30 crore in the same quarter last year.
New Jersey-based Heritage Pharmaceuticals is a generic pharmaceutical company engaged in the acquisition, licensing, development, marketing, sale and distribution of generic pharmaceutical products for the global prescription drug markets.
The US firm established itself as a competitor in the generic pharmaceutical industry by initially targeting niche products with revenues that are generally too small to command the resources and attention of major market participants. It launched its US label in 2006 and currently markets five products over 17 SKU's, including Ethambutol oral tablets, Hydralazine oral tablets, Hydrochlorothiazide oral tablets, Sulindac oral tablets and Nimodipine soft gel capsules.
Heritage's business model utilises strategic outsourcing to US FDA. qualified manufacturing and development organisations in both North America and Asia.
