Glenmark produces anti-diarrhoea ingredient
Glenmark Pharmaceuticals Ltd on Friday said it has successfully produced active pharmaceutical ingredient (API), crofelemer, used for chronic diarrhoea in persons living with HIV/AIDS.
By PTI |
MUMBAI: Glenmark Pharmaceuticals Ltd on Friday said it has successfully produced active pharmaceutical ingredient (API), crofelemer, used for chronic diarrhoea in persons living with HIV/AIDS.
The company is manufacturing this API at their USFDA approved facility in Ankleshwar, Glenmark Pharmaceuticals informed the Bombay Stock Exchange.
"We see this as an important product for India and Glenmarks licensed territories," Glenmark Pharmaceuticals Managing Director and CEO Glenn Saldanha said.
Many diarrhoea diseases are resistant to antibiotics; crofelemers mechanism of action treats the symptoms of dehydration regardless of cause. Furthermore, a strong safety database including over 1200 patients to date will help us target successful registration and launch of crofelemer by 2008 or 2009, Saldanha added.
The company had signed a development and commercialisation alliance with US-based Napo Pharmaceuticals Inc (Napo) in July 2005. Under the terms of the agreement, Glenmark would be responsible for marketing crofelemer in over 140 countries, including India.
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In return Glenmark would provide low-cost and large-scale manufacturing in FDA approved manufacturing facilities and upon marketing would pay royalties ranging from high single digits to early teens on net sales to Napo. Glenmark recently received approval from the Drug Controller General of India (DGCI) to initiate a Phase II trial for acute infectious diarrhoea and is also working on a development plan for the other indications of AIDS related diarrhoea and paediatric diarrhoea.
Napo Pharmaceuticals Inc is focussed on developing and commercialising proprietary pharmaceuticals for the global marketplace, in collaboration with local partners, in order to address major global unmet medical needs in developed and developing countries.
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