上海凡秦醫藥科技有限公司成立于2016年，總部座落于上海市松江工業園區，是一家以專業從事新藥研發和仿制藥物開發、生產和銷售的高新技術企業。 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藥物的合成和純化上有著較強的實力，有十幾年的前列腺素產品研發和生產經驗。 We owns expertise team who proficient in development and production of API and intermediates,such as Prostaglandins.
在新藥開發上，公司與美國知名高校合作，開發系列新型抗腫瘤藥物，并已逐步展開臨床試驗。 Finetechpharm has cooperated with famous university in USA to research new anticancer drugs.
研發實驗室及中試車間位于松江工業園區，具有毫克級至公斤級的化學合成設備。設備可以滿足反應溫度涵蓋-70℃至300℃，高壓氫化，減壓蒸餾等特殊要求。并有百克級規模制備HPLC系統，離子交換樹脂柱、大孔吸附樹脂柱、正反相硅膠柱等純化設備和中控分析儀器。擴建后實驗室面積達到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.
在新藥開發上，公司與美國知名高校合作，開發系列新型抗腫瘤藥物，并已逐步展開臨床試驗。仿制藥上立足化學合成和純化技術平臺，在上海擁有高水平原料藥和醫藥中間體的研發和生產經驗的人才，并建有高標準合成實驗室和多功能中試車間并配有全套檢測設施。公司設有多套公斤級自動化合成反應釜，多套安捷倫、島津、日立等品牌的HPLC和GC以及紫外分光等設備，并配套百克級高壓制備色譜層析系統以及公斤級中低壓制備層析純化系統。可以為客戶提供中間體和雜質的合成純化定制業務。 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.
公司還擁有具備良好資質的合作工廠，結合專業的工藝放大生產團隊，形成了從小試、中試到工業化規模的生產能力，并且通過ISO9001質量認證，全方位滿足客戶定制合成、原料藥中間體生產的需求。 Our company also has friend company for large scale manufacture of big quantity products. And have ISO9001 quality certification.
公司已在浙江紹興和山東濟寧建設GMP合規的生產基地，投資3000萬元。合成反應釜的生產規模可以達到5噸，色譜純化設備可以達到10kg/天；并配套相應的倉儲、檢測、EHS體系。 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.
公司始終堅持“信譽至上，質量第一”的企業信條，視質量為生命，實施GMP管理，為客戶提供全面服務。 公司具有完善的質量管理體系和文件。并擁有多套SHIMADZU液相色譜、氣相色譜、HITACHI紫外分光光度計、旋光儀等系列檢測設備。以滿足質量優先的企業原則。 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.
高新技術企業-證書
ISO質量認證證書-中文
ISO質量認證證書-英文
