西安力邦制药有限公司西安力邦制药有限公司由归国留学人员杨丰收先生于1996年创立，是一家以医药原料和制剂的研究、生产、***和产业化开发为主的现代化新型医药企业，有完整的原料和制剂生产设施，并在脂质体技术的开发和应用方面拥有较强的实力。原料生产基地 其原料中试基地位于西安北郊，占地1000平方米，配备有低温、高压、无水、制备柱层析设备，可以生产手性及高难度复杂化合药物，曾两次通过乐美国FDA检查和三次国家GMP认证。该基地自建立以来，定位在“高附加值、高难度、高科技含量、低产量”的原料药研究开发，立足国内，积极拓展国际市场，取得了长足的发展：6个产品在美国FDA注册，2个产品已通过FDA检查，15个产品通过国家GMP认证，并且有了完善的质量体系，拥有通过GMP、FDA认证的多功能车间、合成室7个，精烘包车间3个。现有员工73人，其中：大专以上学历人员32人，医药及相关专业人员22人，高级工程师3人，工程师12人。坐落在宝鸡的大规模原料生产基地，占地40680平方米，建筑面积18945平方米，厂内绿化面积4000余㎡，不仅能满足上吨批量的原料药生产，还是国内唯一一家专门生产磷脂、聚乙二醇、生物可降解高分子等特殊药用辅料的GMP企业。公司50%以上具有大专以上学历，其中具有高级职称人员5人，中级职称10人，专职技术人员16人，博士生导师2人。制剂生产基地 拥有符合GMP要求的脂肪乳制剂、脂质体、微乳、西林瓶、冻干等专有生产设施。有多年脂肪乳产品生产技术和经验，并自行设计和安装了许多新型装置，其脂肪乳制剂的产业化能力处于制药行业的先进行列。力邦同时具有包括小容量注射剂、大容量注射剂、冻干粉针、片剂、胶囊剂、口服液、滴耳剂、滴眼剂等数条制剂生产线，公司生产工艺先进、设备精良、检测仪器齐备、产品多样，保证了企业的快速发展。核心技术 以微乳技术、脂肪乳技术、脂质体技术为核心，开发新型的载药系统（Drug Delivery System）是力邦的主要研发方向。在微乳技术方面，力邦致力于中药有效成分微乳化制剂的研制，并成功应用了无毒、无刺激性、无不良药理作用和生物相容性的表面活性剂和助表面活性剂方面； 在脂肪乳技术方面，力邦率先进行了载药脂肪乳的研制，已开发出棕榈酸地塞米松脂质乳剂和前列腺素E1脂质乳等制剂；在脂质体技术方面，已经攻克了聚乙二醇修饰脂质体药物制剂中的主要辅料合成和技术难点，使抗癌类的弱碱性药物如阿霉素、长春新碱等都可以应用PH梯度法载入脂质体内，达到99%的药物包封率，粒径控制在纳米级（100nm)，并且载药量远远大于临床需要的浓度。力邦现已成为陕西省脂质体工程技术研究中心，并且脂质体技术项目被确定为国家级高技术产业化示范工程项目。西安力邦制药将继续以规范化、专业化、规模化、国际化、为总体方针，以子公司为经营实体，以产业经营为中心，以管理为基础，以资产、资本经营为手段，以技术研发为加速器，在处方药、OTC和医药原料三大领域中创国内一流、国际先进的健康产业集团。Xi`an LIBANG Pharmaceutical Co, Ltd.As increasing number of multinational pharmaceutical companies are out sourcing API to China. Xian, where LIBNAG locates, the center of northwest pharmaceutical industry of China is attracting more attention. By leveraging its capabilities in chemical synthesis, LIBANG position itself as a technology orientated player to deliver fast and reliable API research and production. LIBANG has enhanced itself by providing fine APIs with well-accepted quality standard, intensive experiences in development and production, documentation for registration purposes, and excellent support for technical questions. LIBANG has specialized in developing generic Active Pharmaceutical Ingredients and related intermediates for customers’ requirements. Strategic alliances and partnership is another strategy to be adopted by LIBANG to speed up its development in the API business. LIBNAG engages in providing not only services of chemicals, but also co-developing.Manufacturing FacilitiesFounded in 1996, LIBANG has owned two cGMP API Plants and one cGMP Formulation plant. Scale-up Plant occupies 10000 square meters, with workshop area of 400 square meters and clean room area of 240 square meters. The plant has been successfully audited by US FDA 2 times and SFDA 3 times since 1999. In the end of 2002, the plant is rebuilt based on the guideline of International recognized cGMP standards, that comprises of 4 synthesis workshops, 9 production workshops, 3 clean workshops and 1 QC lab. The scale-up plant can handle reactions from 1 to 1000 kg scale, the plant is able to handle solid and liquid products, operate the multi tons reactions with a temperature range from -50°C to +200°C, and handle high-pressure reactions. All facilities of the plant are arranged according to requirements of cGMP. Currently, its two products have been approved and certified by FDA, six DMF have registered with the FDA, and fifteen products have been granted GMP Certificate by SFDA.Multi-purpose Plant occupies 40,680 square meters with building area of 18,945 square meters and green coverage area of 4,000 square meters, east of Baoji City, 0.5 km southward of Xi’an-Baoji Expressway, 23 km westward of Baoji downtown. The plant consists of 3 workshops, 1 testing centre and 1 R&D lab. The Multi-purpose plant is equipped with reactors from 100 liters to 2000 liters, which can take on different jobs with quantity from several hundred kilos to several tons to meet customer`s various #, the core products, Purified Egg Phosphatidylcholine ( E80\E98) and PEG will go into mass production. Formulation Plant occupies an area of 10650 square meters with the built-up area of 3000 square meters, which houses a total of three production lines, utility infrastructure, quality assurance and quality control and a warehouse. The plant is designed, constructed and managed under cGMP standards. In 2002, the three production lines: Large Volume Solution, Small Volume Solution, and Lyophilized Powder for injection, are passed SFDA inspection wholly and obtained the national GMP certificates. Aiming to contribute to global pharmaceutical development and manufacturing, maintain competitiveness and promote contract manufacturing through strong manufacturing capabilities, LIBANG have been assessed and remediated the compliance to cGMP regulations following FDA current risk-based inspection technique.Technical Strength LIBANG owns a group of highly skillful technical personnel who have experience over a wide range of chemical reaction technology. Process development is performed in LIBANG Vancouver API Laboratory which is led by 4 Ph.D chemists with over 10 years experience working in the North America pharmaceutical industry. LIBANG focuses on research and development of new processes, designed to ensure the non-infringement of patents, and a large number of efficient processes have been developed over the last several years.Core Technology LIBANG also is one of the leading technology company in the field of lipid based formulation research and development, and has accumulated expertise in liposome, emulsion, PEG, and microsphere related formulation development to solve the most difficult drug delivery challenges and to develop innovative pharmaceutical products. LIBANG’s range of technologies allows us to offer numerous solutions for any drug delivery problem. Our drug delivery technologies can also be used as innovative and effective life cycle management tools that prolong the market life of drug and pharmaceutical products. In 2003, LIBANG was named National Liposmal Drug Delivery Research Centre ? Liposomal encapsulation ? Emulsion? Pegylation? Micro emulsion? Microsphere
