SINGAPORE--(BUSINESS WIRE)--MP Biomedicals Asia Pacific PTE LTD, a subsidiary of MP Biomedicals LLC, a leading multinational company focused in Life Sciences and Diagnostics has received approval from The National Health Surveillance Agency (ANVISA) to market its HIV Blot 2.2, HIV Blot 1.3, HCV Blot 3.0 and HTLV - I/II ELISA 4.0 diagnostic tests in Brazil. This is MP Biomedicals second approval from ANVISA, with the first coming in August of 2010 when the company’s Assure Dengue IgA rapid test was cleared for marketing.
MP Biomedicals will work closely with its distributors and with the blood centers in Brazil to introduce these high value diagnostic products. “Blood safety is important to us and we hope to make a continuing contribution in Brazil with our technology. With over 4.3 million donations annually, Brazil is an important member of the global blood screening community and we are delighted that ANVISA recognizes our quality and has given us the green light to market our products,” said Milan Panic, Founder and CEO of MP Biomedicals LLC. MP Biomedicals HTLV –I/II has received approval of its investigational new drug application (IND) by the U.S. Food and Drug Administration (FDA) to start pivotal clinical trials I n the United States under the direction of Dr. Susan Stramer, Executive Scientific Officer of the American Red Cross.
About ANVISA
The National Health Surveillance Agency (ANVISA), Brazil is designated as an autonomous agency operating under a special regime. ANVISA is an independently administered, financially-autonomous regulatory agency, with security of tenure for its directors during the period of their mandates. Within the structure of Federal Public Administration, the Agency is linked to the Ministry of Health. The agency incorporated additional attributions: coordination of the National Sanitary Surveillance System (SNVS), the National Program of Blood and Blood Products and the National Program of Prevention and Control of Hospital Infections; monitoring of drug prices and prices of medical devices; attributions pertaining to regulation, control and inspection of smoking products; technical support in granting of patents by the National Institute of Industrial Property. For more information please visit www.anvisa.gov.br.
About MP Biomedicals LLC
MP Biomedicals is a world-wide corporation, with ISO-certified and FDA-approved manufacturing and distribution facilities throughout the globe and headquartered in Southern California. MP Biomedicals manufactures and sells more than 55,000 products and is one of the only companies in the industry to offer a comprehensive line of life science, fine chemical and diagnostic products. MP Biomedicals Diagnostics manufacture and market their high quality diagnostics products in Western Blot, ELISA, Rapid Test segments with over 25 years of research and development. A vast network of global distributors and satellite facilities and offices throughout Europe, Asia, Australia and the Americas assures customers top quality products delivered when and where needed. For more information please visit www.mpbio.com.