By IANS
Mumbai : Glenmark Pharmaceuticals Inc. has started the shipping of its non-steroid and anti-inflammatory drug to the US following approval by the country’s drug authorities.
Informing the Bombay Stock Exchange (BSE) about this Thursday, the company said that the US Food and Drug Administration (FDA) has given its approval for two of its drugs – Nabumetone and Hydoxyzine Hydrochloride – through its partnership with InvaGen Pharmaceuticals Inc.
The company said that while Glenmark would exclusively market and distribute the approved drugs, InvaGen would be responsible for the manufacture and supply of the tablets.
As per the signed agreement, the two companies will equally share the costs and profits arising from the manufacturing and marketing of the drugs.
The company, quoting pharmaceutical data analysts Intercontinental Marketing Services (IMS), said that the sale of Nabumetone, used in the treatment of pain and inflammation caused by arthritis, touched $97 million in the period ending December 2007.
Similarly, Hydroxyzine, which belongs to the category of sedating histamines, had a market size of $60 million in the same period.
The recent approval of the two drugs takes Glenmark’s portfolio to 28 generic products for the US market. At present the company has over 35 Abbreviated New Drug Applications (ANDA) undergoing review with the FDA for approval and launch.