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艾博生物医药(杭州)有限公司

外商独资 · 1000人以上
公司所有职位
公司简介

艾博生物医药(杭州)有限公司是一家成立于2003年的高科技生物技术外资企业,坐落于国家开发区—杭州经济技术开发区(下沙)医药园区内,是杭州经济技术开发区2003年重点引进的外商独资企业。 公司主要从事研究、开发、生产体外诊断试剂;销售本公司生产的产品,并提供技术服务。公司投资总额2998万美元,注册资本1200万美元。公司产品已获美国FDA注册和欧洲CE注册,主导产品为快速诊断产品,包括妊娠检测、传染病检测、毒品检测、肿瘤标志物检测和心脏病标志物检测等五大系列,畅销全球100多个国家和地区,在北美、欧洲、以色列、澳大利亚、日本、新西兰等国际市场上占有较高的份额。 公司拥有强大的科研开发和技术创新能力,在胶体金、乳胶等标记技术、单克隆抗体,多克隆抗体,基因重组抗原,合成抗原等生物原料技术,以及免疫层析技术等前沿生物领域的研究方面处于国内领先水平。公司已通过了国家食品药品监督管理主管部门的GMP认证和欧洲TÜV的ISO13485:2003质量管理体系认证并被国家发展和改革主管部门认定为国家高技术产业化示范工程项目。

Established in 2003, ABON Biopharm (Hangzhou) Co., Ltd is located in one of the most prestigious economy and technology development zones in China: the Hangzhou City Economy and Technology Development Zone. The manufacture facility was designed by a San Diego, California architect firm, with garden-like building areas of approximately 30,000 sq. meters or 300,000 sq. ft. divided into manufacturing areas, R&D labs, offices and multifunctional supporting facilities, such as a multifunctional auditorium for 300 persons. There are over 900 employees currently working in this state-of-the-art in vitro diagnostic (IVD) device manufacturing facility equipped with all the necessary amenities of a modern IVD manufacturing facility. The designing and building of ABON Biopharm manufacturing facility was with global visions to comply with every quality system requirement established with various countries and regions. ABON Biopharm has been registered with the U. S. FDA as a medical device establishment. It also has ISO 13485:2003 and the Japanese jGMP certifications as an IVD device manufacturing establishment. Recently the facility passed the Chinese GMP inspection. It has also registered with the regulatory agencies of Canada and Australia as a qualified medical device manufacturer to supply products to these countries. ABON Biopharm is thriving on innovative research, fast product development, efficient manufacturing and high volume marketing and sales of the lateral flow rapid IVD products based on an impeccable business philosophy of high quality, competitive price, flexible customer OEM product design and superior customer service. The ABON lateral flow rapid IVD products lines include tests for drugs of abuse, infectious disease, fertility, tumor markers, and cardiac markers. Many of these products are FDA 510K cleared and/or bear CE Mark. They are now commanding very good market shares in the United States, Canada, European Union, Israel, Australia, New Zealand and Japan markets. Since April 2006, ABON Biopharm manufacturing facility, together with its sister company Innovacon Inc. located in San Diego, California, U.S.A., has been acquired by the Inverness Medical Innovations (IMI). As ABON Biopharm is transitioning into the Inverness business family, it is positioning itself to become the global manufacturing center for the IMI organization

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