Mumbai: Glenmark Pharmaceutical's US subsidiary Glenmark Generics has launched morphine sulfate oral concentrate solution in the US, its fifth product in the painkiller category to be sold in the US.

Glenmark will market the product through a licensing agreement with a US-based pharmaceutical development company, according to a filing with the Bombay Stock Exchange.

Morphine sulfate oral concentrate solution20mg/ml is offered in three presentations and is indicated for the relief of moderate to severe pain.

Morphine sulfate oral concentrate solution had total sales in excess of $15 million for the 12 month period ended June 2008, according to IMS Health.

This product launch complements Glenmark's established portfolio of both oral solid and oral liquid pain management products.

''This niche market category maintains a high barrier to entry due to strict DEA regulations thereby limiting the number of competitor companies and showcasing Glenmark as the sole India-based company in each of their product launches'', the company said.

These products are manufactured for Glenmark in the United States through a partnership and are distributed directly from GGI's warehouse located in Mahwah, New Jersey.

Glenmark's current portfolio consists of 36 products authorised for distribution in the US marketplace. The company has 40 ANDAs in various stages of approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

Glenmark Generics Limited has an established presence in North America, the EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in formulations development with teams operating out of laboratories in India and Latin America. The company has a state-of-the-art manufacturing plant in Goa, that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities.

GGL also markets over 45 APIs to more than 80 countries across the world and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai. Its shares are listed on the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5,500 people across its global operations over 85 countries.