Ranbaxy’s anti-HIV drug Indinavir gets WHO prequalification

Indinavir, anti HIV drug from Ranbaxy Laboratories Limited has been included pre-qualification list of  the World Health Organisation, Geneva (WHO), the company announced.

Ranbaxy Laboratories’s  Indinavir (as sulfate) – 400mg anti retroviral (ARV) capsule is used in the treatment of HIV/AIDS.

With the inclusion of Indinavir, Ranbaxy now has a total of 19 ARVs on the WHO pre-qualification list.

Ranbaxy’s ARVs, including the recently approved WHO pre-qualified products, are manufactured at the company’s state-of-the-art manufacturing facilities.

Ranbaxy has been providing ARV medicines in over 70 markets worldwide.

Ranbaxy’s ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional.

ARV medicine produced by Ranbaxy are used by over 400000 patients worldwide , in various developing and underdeveloped countries.

Indian generic maker Cipla Ltd’s  version of Roche’s oseltamivir (Tamiflu) has been included in WHO’s prequalification list, in May.

WHO’s Prequalification Programme aims to make quality priority medicines available for the benefit of those in need. WHO achieves this through its evaluation and inspection activities, and by building national capacity for sustainable manufacturing and monitoring of quality medicines.

WHO’s strategy for pre-qualified drugs includes: applying unified standards of acceptable quality, safety and efficacy; evaluating the quality, safety and efficacy of medicinal products, based on information submitted by the manufacturers, and inspection of the corresponding manufacturing and clinical sites; prequalifying quality control laboratories of pharmaceuticals and build the capacity of staff from national regulatory authorities, quality control laboratories, and from manufacturers or other private companies, to ensure medicines quality.

WHO’s list of prequalified medicinal products used for HIV/AIDS, malaria, tuberculosis and for reproductive health produced by the Programme is used principally by United Nations agencies — including UNAIDS and UNICEF — to guide their procurement decisions.

WHO’s prequalified medicines list has become a vital tool for any agency or organization involved in bulk purchasing of medicines, be this at country level, or at international level, as demonstrated by the Global Fund to Fight AIDS, Tuberculosis and Malaria.

Daiichi-controlled Ranbaxy Laboratories Ltd has posted a third-quarter profit before tax at USD 33 Mn (Rs. 1,601 Mn) with an EBITDA margin of 13% to sales for the quarter ending on September 30, boosted by earnings fro emerging market sales including India and South Africa.

Net income was 1.17 billion rupees ($25 million) compared with a year-earlier loss of 3.95 billion rupees.

Sales in India, South Africa and other emerging markets contributed for 62 percent of Ranbaxy’s revenue.

Developed markets de-grew by 30%, primarily on account of loss of sales in USA because of the import alert and Application Integrity Policy imposed by the USFDA.

North American region recorded sales of USD 61 Mn (Rs. 2,955 Mn) during the quarter, a de-growth of 43%.

In USA, sales during the quarter were USD 44 Mn (Rs. 2,138 Mn), a de-growth of 53% over Q3’08. This was primarily on account of ongoing USFDA issues and the discontinuation of omeprazole authorized generic.