Ranbaxy gets nod to market, manufacture ARV combination for child

New Delhi, Dec 6 (UNI) Pharma major Ranbaxy Laboratories Ltd today said it has received the go-head to manufacture and market Coviro-LS kid and Coviro-LS kid DS, both double Anti-Retroviral (ARV) and fixed dose combination, dispersible tablets for treatment of HIV infection in children in the country.

''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,'' company' CEO and Managing Director Malvinder Mohan Singh said.

The company has also filed the products with WHO Geneva for pre-qualification, a statement said.

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 statement added.

While convenient triple and double fixed dose combinations are widely available for adults, children have so far had to largely rely on 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.

Since 2001, Ranbaxy has been providing high quality ARV medicines to countries and patients afflicted by HIV/AIDS. The company's ARVs have been used as mainstays in various large treatment programmes, both national and ngo/institutional with good results. Ranbaxy's ARV products are sold in over 50 countries.

The Company presently has 15 ARVs on the WHO pre-qualification list of which three are USFDA approved.

UNI