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Ranbaxy Laboratories Limited announced today that the Company has received approval to manufacture and market Coviro-LS kid and Coviro-LS kid DS, both double Anti-Retroviral (ARV) and fixed dose combination, dispersible tablets for children, in India
GURGAON, India | December 6, 2007 | Ranbaxy Laboratories Limited (RLL), announced today that the Company has received approval to manufacture and market Coviro-LS kid and Coviro-LS kid DS, both double Anti-Retroviral (ARV) and fixed dose combination, dispersible tablets for children, in India. The company has also filed the products with WHO Geneva for pre-qualification.
While Coviro-LS kid contains Lamivudine 20mg and Stavudine 5mg, Coviro-LS kid DS contains the drugs in 40mg and 10mg strengths respectively. The products are bio-equivalent with the individual liquid formulations of the originators. The products are indicated for treatment of HIV infection in children.
“Ranbaxy is committed to develop innovative ARVs at affordable cost. We strongly believe that with these new formulations, we will be able to make accessible, a high quality and convenient treatment to a large number of HIV-positive children who are therapeutically among the most neglected ”, said Mr. Malvinder Mohan Singh, CEO and Managing Director, RLL.
Both the approved formulations are scored dispersible tablets, and are pleasantly flavored. The products are designed to deliver two ARV drugs together in recommended strengths and simplify delivery of a more accurate treatment to children in resource poor settings. Last year Ranbaxy had launched two Triple ARV combinations for children: Triviro-LNS kid and Triviro-LNS kid DS. With Launch of double combination Ranbaxy has now four dispersible formulations for Paediatric HIV/AIDS treatment.
While convenient triple and double fixed dose combinations are widely available for adults, children have so far had to largely rely on cumbersome options such as simultaneously taking multiple liquid ARV drugs or crushing and taking unpalatable adult triple drug formulations, an activity that does not deliver the three drugs in a ratio that is optimal for children. Most current options make compliance to therapy very difficult both for children and care-givers and may increase risk of resistance or adverse effects due to non-compliance.
Presently there are 2.3 million HIV-positive children in developing countries and about 500,000 of them die every year, with about 90% not living beyond their second birthday. It is estimated that about 780,000 children presently need ARVs while only about 100,000 have access.
Since 2001, Ranbaxy has been providing high quality ARV medicines, at affordable prices, to countries and patients afflicted by HIV/AIDS. The Company's ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional with good results. Ranbaxy is committed to supporting the global fight against HIV/AIDS through high quality, affordable medicines and its ARV products are sold in over 50 nations.
The Company presently has 15 ARVs on the WHO pre-qualification list of which three are USFDA approved.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
SOURCE: Ranbaxy |
