Lamivudine API referenced by Apotex for use in ApoTriavirÔ
–product provided to Rwanda government under historic compulsory license agreement
Taihe, China (May 22, 2008) – The national drug regulatory agency of Canada, Health Canada,has recently approved a Lamivudine DMF from Anhui Biochem United Pharmaceutical ("Anhui Biochem"). This approval was triggered by Apotex, Canada’s largest pharmaceutical company, selecting Anhui Biochem’s Lamivudine API to be used in their antiretroviral drug ApoTriavir. Chairman of Anhui Biochem, Mr. Wang Zhibang commented, "I am very pleased for our lamivuidne API proudct to be recognized to meet the highest quality standards of a stringent regulatory authority like Health Canada." He continued, "we are proud to have coooperated with Apotex on this historic product and are honored to know that our product will be used to treat people suffering from HIV/AIDS in Rwanda."
A compulsory licence was recently issued for ApoTriavir under Canada’s Access to Medicines Regime Program (CAMR) allowing Apotex to proceed with manufacturing of the product. This drug – a triple fixed-dose combination of Lamivudine, Zidovudine and Nevaripine – was the first product to be approved by Health Canada under the provisions of the CAMR. Rwanda was the first country to request ApoTriavir under this established process. ApoTriavir was approved by Health Canada in August 2006 and is pre-qualified by the World Health Organization.
Anhui Biochem United Pharmaceutical Co., Ltd is one of the leading pharmaceutical manufacturing enterprises in China specializing in the development of high quality Anti-HIV/AIDS intermediates, active pharmaceutical ingredients and finished pharmaceutical products.