成立于1997年,國內造影劑仿制藥產品中規模大/品種齊全的工廠,旗下上海司太立生產碘帕醇注射液/碘海醇注射液和碘克沙醇注射液等造影劑產品
浙(zhe)江(jiang)司(si)太立制(zhi)藥(yao)(yao)(yao)股(gu)(gu)份有(you)限公(gong)司(si)成立于1997年(nian),是(shi)一家(jia)專門(men)從(cong)事研發、生產(chan)、銷售X-CT非離(li)子型造影劑系(xi)列(lie)和喹諾(nuo)酮類(lei)系(xi)列(lie)原料藥(yao)(yao)(yao)及(ji)中間體的高(gao)新技術企業(ye),是(shi)國(guo)內造影劑仿(fang)制(zhi)藥(yao)(yao)(yao)產(chan)品(pin)中規模大、品(pin)種齊(qi)全(quan)的工廠。“十二五”期間,公(gong)司(si)向產(chan)業(ye)鏈的前端(duan)(duan)和末(mo)端(duan)(duan)延伸,于2011年(nian)1月(yue)在江(jiang)西樟樹(shu)建(jian)立中間體生產(chan)基地——江(jiang)西司(si)太立制(zhi)藥(yao)(yao)(yao)有(you)限公(gong)司(si),于2012年(nian)6月(yue)在上(shang)海金山建(jian)立制(zhi)劑工廠——上(shang)海司(si)太立制(zhi)藥(yao)(yao)(yao)有(you)限公(gong)司(si)。2016年(nian)3月(yue)9日(ri),公(gong)司(si)在上(shang)海證券交易(yi)所(suo)上(shang)市(shi),股(gu)(gu)票代碼:603520。2018年(nian)11月(yue),公(gong)司(si)成功(gong)收購國(guo)內同行企業(ye)——浙(zhe)江(jiang)臺州海神制(zhi)藥(yao)(yao)(yao)有(you)限公(gong)司(si),邁入高(gao)速發展的快車(che)道。
在過去的(de)(de)(de)二十多年里,公司(si)始終保持良好(hao)穩(wen)定的(de)(de)(de)發展勢頭,成為國內X-CT非離子型造影劑原(yuan)料(liao)藥(yao)(yao)龍頭企業。其(qi)中,碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)原(yuan)料(liao)藥(yao)(yao)產(chan)(chan)(chan)(chan)能及產(chan)(chan)(chan)(chan)量(liang)位居國內首位。公司(si)產(chan)(chan)(chan)(chan)品質量(liang)穩(wen)定,并取得(de)多個發達國家(jia)(jia)認證(zheng)(zheng)。公司(si)生產(chan)(chan)(chan)(chan)的(de)(de)(de)原(yuan)料(liao)藥(yao)(yao)碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)帕醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)克沙(sha)(sha)(sha)醇(chun)(chun)(chun)、左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)、鹽(yan)酸左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)獲(huo)得(de)國家(jia)(jia)藥(yao)(yao)品GMP證(zheng)(zheng)書(shu);原(yuan)料(liao)藥(yao)(yao)碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)帕醇(chun)(chun)(chun)獲(huo)得(de)歐盟(meng)(meng)CEP證(zheng)(zheng)書(shu);原(yuan)料(liao)藥(yao)(yao)碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)帕醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)克沙(sha)(sha)(sha)醇(chun)(chun)(chun)、左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)、鹽(yan)酸左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)獲(huo)得(de)國內注冊批件;原(yuan)料(liao)藥(yao)(yao)碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)帕醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)克沙(sha)(sha)(sha)醇(chun)(chun)(chun)、左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)獲(huo)得(de)印度注冊批件;原(yuan)料(liao)藥(yao)(yao)碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)、碘(dian)(dian)(dian)(dian)(dian)帕醇(chun)(chun)(chun)、左(zuo)(zuo)氧(yang)(yang)氟(fu)沙(sha)(sha)(sha)星(xing)(xing)、洛索洛芬鈉和中間體左(zuo)(zuo)氧(yang)(yang)環合酯獲(huo)得(de)日(ri)(ri)本登錄證(zheng)(zheng)。目前,獲(huo)得(de)歐盟(meng)(meng)CEP證(zheng)(zheng)書(shu)的(de)(de)(de)全球碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)原(yuan)料(liao)藥(yao)(yao)生產(chan)(chan)(chan)(chan)廠家(jia)(jia)有(you)4家(jia)(jia),中國僅司(si)太(tai)立(li)(含海(hai)(hai)神制(zhi)藥(yao)(yao))一家(jia)(jia);獲(huo)得(de)日(ri)(ri)本登錄證(zheng)(zheng)的(de)(de)(de)全球碘(dian)(dian)(dian)(dian)(dian)海(hai)(hai)醇(chun)(chun)(chun)原(yuan)料(liao)藥(yao)(yao)生產(chan)(chan)(chan)(chan)廠家(jia)(jia)有(you)4家(jia)(jia),司(si)太(tai)立(li)(含海(hai)(hai)神制(zhi)藥(yao)(yao))亦是其(qi)中之一。
在喹諾酮類系(xi)列原料藥方面,公司在左氧氟沙(sha)星(xing)(xing)系(xi)列產品(pin)雜質分離及合成領域處于(yu)國內領先水平,是國內產量較大的(de)左氧氟沙(sha)星(xing)(xing)系(xi)列生(sheng)產企(qi)業(ye)之(zhi)一。
公司著(zhu)眼于X射線造影(ying)劑(ji)(ji)的可持續(xu)發(fa)展(zhan)戰略,高度重視自主研(yan)發(fa)能力(li),并取得(de)了豐(feng)碩的成果(guo)。公司是浙(zhe)江省企(qi)業技術(shu)中心(xin)和浙(zhe)江省非離(li)(li)子(zi)型造影(ying)劑(ji)(ji)高新技術(shu)研(yan)究中心(xin)。公司承擔的“非離(li)(li)子(zi)型X-CT造影(ying)劑(ji)(ji)原料藥(yao)(yao)(yao)—碘(dian)海醇(chun)(chun)”項目和“第四代喹諾(nuo)酮類(lei)抗菌藥(yao)(yao)(yao)物(wu)關鍵中間體(ti)帕珠沙(sha)星產(chan)業化”項目均(jun)獲(huo)得(de)了由中華人民(min)共和國(guo)科學技術(shu)部火炬(ju)高技術(shu)產(chan)業開發(fa)中心(xin)頒發(fa)的“國(guo)家(jia)火炬(ju)計劃項目證書”。原料藥(yao)(yao)(yao)碘(dian)海醇(chun)(chun)和帕珠沙(sha)星還(huan)被(bei)浙(zhe)江省科學技術(shu)廳評(ping)定為“浙(zhe)江省高新技術(shu)產(chan)品”。
2020年,公(gong)(gong)司(si)(si)旗下全資子公(gong)(gong)司(si)(si)上海司(si)(si)太(tai)(tai)立制藥(yao)(yao)(yao)有(you)限(xian)公(gong)(gong)司(si)(si)申報的碘帕醇注(zhu)(zhu)(zhu)射(she)液、碘海醇注(zhu)(zhu)(zhu)射(she)液和碘克沙醇注(zhu)(zhu)(zhu)射(she)液等(deng)產(chan)品通(tong)過(guo)國(guo)家新4類(lei)注(zhu)(zhu)(zhu)冊(視同通(tong)過(guo)“藥(yao)(yao)(yao)物一致性評價”),獲(huo)得(de)國(guo)家藥(yao)(yao)(yao)品監督(du)管理(li)局的注(zhu)(zhu)(zhu)冊批件。上海司(si)(si)太(tai)(tai)立制藥(yao)(yao)(yao)有(you)限(xian)公(gong)(gong)司(si)(si)補充了(le)司(si)(si)太(tai)(tai)立制藥(yao)(yao)(yao)產(chan)業(ye)鏈在制劑部分的空(kong)白(bai),使公(gong)(gong)司(si)(si)成功地完成了(le)從原料藥(yao)(yao)(yao)向制劑拓展的產(chan)業(ye)轉型(xing)升級(ji)。
公司以“聚合生命(ming)能(neng)量(liang),呵護人類健康”為經(jing)營理(li)念,不(bu)斷豐富X射線造影劑(ji)系(xi)列(lie)產品(pin),公司將(jiang)力爭成為中國乃至全球(qiu)知名的醫藥(yao)企(qi)業(ye)。
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