上海凡秦医药科技有限公司成立于2016年，总部座落于上海市松江工业园区，是一家以专业从事新药研发和仿制药物开发、生产和销售的高新技术企业。 Shanghai Finetech pharm Co., Ltd. was founded in 2016,and located in Shanghai Songjiang industry area, which provides service for new/generic drug research and GMP manufacture.Finetech Pharm is also one of chiinese High Technology Enterprises.
公司在前列腺素等高活性药物的合成和纯化上有着较强的实力，有十几年的前列腺素产品研发和生产经验。 We owns expertise team who proficient in development and production of API and intermediates,such as Prostaglandins.
在新药开发上，公司与美国知名高校合作，开发系列新型抗肿瘤药物，并已逐步展开临床试验。 Finetechpharm has cooperated with famous university in USA to research new anticancer drugs.
研发实验室及中试车间位于松江工业园区，具有毫克级至公斤级的化学合成设备。设备可以满足反应温度涵盖-70℃至300℃，高压氢化，减压蒸馏等特殊要求。并有百克级规模制备HPLC系统，离子交换树脂柱、大孔吸附树脂柱、正反相硅胶柱等纯化设备和中控分析仪器。扩建后实验室面积达到2800平米。 R&D center and pilot workshop is located in Qinpu area of Shanghai, and posses sveral synthesis and purification instruments. We also possess preparative HPLC system forhundred grams scale and LC purification systems.
在新药开发上，公司与美国知名高校合作，开发系列新型抗肿瘤药物，并已逐步展开临床试验。仿制药上立足化学合成和纯化技术平台，在上海拥有高水平原料药和医药中间体的研发和生产经验的人才，并建有高标准合成实验室和多功能中试车间并配有全套检测设施。公司设有多套公斤级自动化合成反应釜，多套安捷伦、岛津、日立等品牌的HPLC和GC以及紫外分光等设备，并配套百克级高压制备色谱层析系统以及公斤级中低压制备层析纯化系统。可以为客户提供中间体和杂质的合成纯化定制业务。 Finetechpharm has cooperated with famous university in USA to research new anticancer drugs. For generic we have devoted to build platform of chemical synthesis and purification technology. Finetechpharm owns expertise team who proficient in development and production of API and intermediates, and we also have built high standard laboratory and multi-function workshop equipped with full set of testing facilities. We have several automatic synthesis tanks for Kg scale, and several HPLC/GC/UV instrum-ents with the brands of Agilent/Shimadzu/Hitachi. We also possess preparative HPLC system for hundred grams scale and LC purification systems for Kg scale. Thus we can provide excellent services for API intermediates and impurities.
公司还拥有具备良好资质的合作工厂，结合专业的工艺放大生产团队，形成了从小试、中试到工业化规模的生产能力，并且通过ISO9001质量认证，全方位满足客户定制合成、原料药中间体生产的需求。 Our company also has friend company for large scale manufacture of big quantity products. And have ISO9001 quality certification.
公司已在浙江绍兴和山东济宁建设GMP合规的生产基地，投资3000万元。合成反应釜的生产规模可以达到5吨，色谱纯化设备可以达到10kg/天；并配套相应的仓储、检测、EHS体系。 The company has built a GMP compliance production base in Shandong Province, with an investment of 30 million yuan. The production scale of synthetic reactor can reach 5 tons, the chromatographic purification equipment can reach 10 kg/day, and the corresponding storage, detection and EHS systems are also provided.
公司始终坚持“信誉至上，质量第一”的企业信条，视质量为生命，实施GMP管理，为客户提供全面服务。 公司具有完善的质量管理体系和文件。并拥有多套SHIMADZU液相色谱、气相色谱、HITACHI紫外分光光度计、旋光仪等系列检测设备。以满足质量优先的企业原则。 Finetech insists on value of credibility &quality, and always engages inproviding professional service to worldwide customers. Finetech Pharm has several SHIMADZU HPLC systems and HITACHI ultraviolet spectrometer.
高新技术企业-证书
ISO质量认证证书-中文
ISO质量认证证书-英文
