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BY A CORRESPONDENT May 31, 2005: Ranbaxy Laboratories Limited (RLL) has announced that it has received a tentative nod from the US Food and Drug Administration (USFDA) to manufacture and market Lamivudine Tablets, 150 mg. This is Ranbaxy’s first tentative okay from the USFDA under its expedited review process to support PEPFAR. In combination with other anti retroviral agents (ARVs), Lamivudine Tablets are indicated for the treatment of HIV infection.
Ranbaxy's anti retroviral agents including Lamivudine Tablets 150mg are manufactured at Ranbaxy's manufacturing facilities inspected and approved by some of the most stringent agencies in the world, including the USFDA. The Contract Research Organisations (CROs) used by Ranbaxy to carry out bio-equivalence studies for its ARVs are claimed to be globally respected and conduct and file their studies routinely with some of the most stringent regulatory authorities around the world. The CROs also regularly go through routine audits by these regulatory authorities.
Ranbaxy CEO and Managing Director Brian Tempest said, “We are pleased with the tentative approval for Lamivudine granted by the USFDA. This is a major step in making our life saving ARV medicines available to more and more HIV/AIDS patients in the developing world. We will continue with our efforts to obtain speedy approval for all our ARVs with the USFDA in support of PEPFAR. In tandem we are also pursuing WHO prequalification for the same products.”
Ranbaxy, which is India's largest pharmaceutical company, makes and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. 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.
BY A CORRESPONDENT
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