Ranbaxy Press Release WHO Prequalification

New Delhi
August 04, 2004

An audit was carried out recently by World Health Organisation (WHO), on an independent Contract Research Organisation (CRO) in India that conducts bio-equivalence studies for many international pharmaceutical companies. During the audit, certain anomalies were observed in data handling and non-compliance with good clinical and laboratory practices relating to the bio-equivalence studies carried out by this CRO on three of Ranbaxy’s Anti Retrovirals (ARVs). While these anomalies are being investigated, all further outsourcing work to this CRO has been suspended by Ranbaxy.

As a part of its commitment to HIV/AIDS patients and to the WHO, Ranbaxy has already initiated work on new bio-equivalence studies on these three products. In addition, Ranbaxy is providing all necessary cooperation to WHO on its HIV franchise.

Ranbaxy confirms its products are manufactured at the Company’s world class facilities that are routinely inspected and approved by WHO-Geneva for compliance to Good Manufacturing Practices (GMP) and meet all required quality standards and specifications.

Ranbaxy has been at the forefront in addressing the healthcare needs of HIV/AIDS patients by providing quality and cost effective ARVs including Fixed Dose Combinations (FDCs). These safe and efficacious products have been extensively used since 2001, and have been available in more than 40 countries. The Company’s ARVs have been used as mainstays in various large treatment programs, both National and NGO/Institutional.

Last month, Ranbaxy initiated a program to file all its ARVs under the expedited review process for the US President's Emergency Plan for AIDS Relief (PEPFAR) with the first filing expected before the end of 2004. The first bio-equivalence study under that program is being planned at a CRO in North America.

Ranbaxy Laboratories Limited, India's largest pharmaceutical Company, manufactures and markets branded 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 34 countries and manufacturing operations in 7 countries.

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