Gilead Sciences, Inc. has signed eight new non-exclusive license agreements with generic companies in India. These licensing agreements grant to Alkem Laboratories Ltd., Aurobindo Pharma Ltd., FDC Ltd., J.B. Chemicals and Pharmaceuticals Ltd., Matrix Laboratories Ltd., Medchem International, Ranbaxy Laboratories and Shasun Chemicals and Drugs Ltd. the rights to produce and distribute generic versions of tenofovir disoproxil fumarate (tenofovir DF) to 95 low-income countries around the world, including India. Tenofovir DF is sold by Gilead under the brand name Viread.
The license agreements require that the generic companies meet certain national and international regulatory standards and include a technology transfer to enable expeditious production of large volumes of high-quality generic versions of Tenofovir DF. In addition, these agreements allow the manufacture of commercial quantities of both active pharmaceutical ingredient (API) and finished product. In August, Gilead announced similar agreements with India-based Emcure Pharmaceuticals Ltd., Hetero Drugs Ltd. and Strides Arcolab Ltd.
"We are pleased to have established agreements with eight additional India-based manufacturers, further expanding capacity for production and distribution in India and in other developing world countries," said John C. Martin, PhD, President and CEO of Gilead Sciences. "We hope that these agreements will expedite access to therapy for patients in resource-limited parts of the world where the HIV epidemic has hit the hardest."