上海凡秦醫(yī)藥科技有限公司成立于2016年，總部座落于上海市金山工業(yè)園區(qū)，是一家以專業(yè)從事新藥研發(fā)和仿制藥物開發(fā)、生產(chǎn)和銷售的高新技術(shù)企業(yè)。 Finetech Biopharmaceutical Technology (Shanghai) Co., Ltd.， was founded in 2016,and located in Shanghai Jinshan industry area, which provides service for new/generic drug research and GMP manufacture.Finetech Pharm is also one of chinese 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(qiáng)的實(shí)力，有十幾年的前列腺素產(chǎn)品研發(fā)和生產(chǎn)經(jīng)驗(yàn)。 We owns expertise team who proficient in development and production of API and intermediates,such as Prostaglandins.
在新藥開發(fā)上，公司與美國(guó)知名高校合作，開發(fā)系列新型抗腫瘤藥物，并已逐步展開臨床試驗(yàn)。 Finetech Biopharmaceutical Technology Co., Ltd. has cooperated with famous university in USA to research new anticancer drugs.
研發(fā)實(shí)驗(yàn)室及中試車間位于金山工業(yè)園區(qū)，具有毫克級(jí)至公斤級(jí)的化學(xué)合成設(shè)備。設(shè)備可以滿足反應(yīng)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(jí)規(guī)模制備HPLC系統(tǒng)，離子交換樹脂柱、大孔吸附樹脂柱、正反相硅膠柱等純化設(shè)備和中控分析儀器。擴(kuò)建后實(shí)驗(yàn)室面積達(dá)到2800平米。 R&D center and pilot workshop is located in Jinshan 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(fā)上，公司與美國(guó)知名高校合作，開發(fā)系列新型抗腫瘤藥物，并已逐步展開臨床試驗(yàn)。仿制藥上立足化學(xué)合成和純化技術(shù)平臺(tái)，在上海擁有高水平原料藥和醫(yī)藥中間體的研發(fā)和生產(chǎn)經(jīng)驗(yàn)的人才，并建有高標(biāo)準(zhǔn)合成實(shí)驗(yàn)室和多功能中試車間并配有全套檢測(cè)設(shè)施。公司設(shè)有多套公斤級(jí)自動(dòng)化合成反應(yīng)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(shè)備，并配套百克級(jí)高壓制備色譜層析系統(tǒng)以及公斤級(jí)中低壓制備層析純化系統(tǒng)。可以為客戶提供中間體和雜質(zhì)的合成純化定制業(yè)務(wù)。 Finetech Biopharmaceutical Technology Co., Ltd.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. We 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(zhì)的合作工廠，結(jié)合專業(yè)的工藝放大生產(chǎn)團(tuán)隊(duì)，形成了從小試、中試到工業(yè)化規(guī)模的生產(chǎn)能力，并且通過ISO9001質(zhì)量認(rèn)證，全方位滿足客戶定制合成、原料藥中間體生產(chǎn)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(jì)寧建設(shè)GMP合規(guī)的生產(chǎn)基地，投資3000萬元。合成反應(yīng)釜的生產(chǎn)規(guī)模可以達(dá)到5噸，色譜純化設(shè)備可以達(dá)到10kg/天；并配套相應(yīng)的倉(cāng)儲(chǔ)、檢測(cè)、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(jiān)持“信譽(yù)至上，質(zhì)量第一”的企業(yè)信條，視質(zhì)量為生命，實(shí)施GMP管理，為客戶提供全面服務(wù)。 公司具有完善的質(zhì)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(jì)、旋光儀等系列檢測(cè)設(shè)備。以滿足質(zhì)量?jī)?yōu)先的企業(yè)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(shù)企業(yè)-證書
ISO質(zhì)量認(rèn)證證書-中文
ISO質(zhì)量認(rèn)證證書-英文
