Ranbaxy makes further three filings of its Anti-Retroviral (ARVs) formulations

Ranbaxy Laboratories Limited has announced that the Company has made further three filings of its Anti-Retroviral (ARVs) formulations, to the World Health Organization (WHO) for its approval under the latter's pre-qualification project for HIV/AIDS drugs.

This takes the total number of filings submitted by Ranbaxy to the WHO to eleven, of which, five are fixed dose combinations (FDCs). All the ARVs filed by the company to WHO are manufactured at a plant inspected and approved by the USFDA. The Contract Research Organizations used by Ranbaxy to carry out these bio-equivalence studies are globally reputed and conduct and file their studies routinely with some of the most stringent regulatory authorities around the world.

Commenting on the progress of the company's ARV filings, Dr. Brian W. Tempest, CEO & MD, Ranbaxy, said, "With these recent filings, we have already resubmitted the majority of our dossiers with WHO. We are working with speed and focus to submit almost all our ARVs with WHO and USFDA this year. We are committed to making these affordable, quality medicines available throughout the world, particularly to patients in those developing countries, who might not otherwise be able to access this life saving therapy."

HIV/AIDS is a serious pandemic that now infects some 40 million people around the globe. More than 20 million individuals have so far succumbed to this devastating disease.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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