江蘇天士(shi)力帝(di)(di)益藥(yao)(yao)(yao)業有限(xian)公(gong)(gong)司是天士(shi)力醫(yi)藥(yao)(yao)(yao)集團股份(fen)有限(xian)公(gong)(gong)司全資子公(gong)(gong)司,公(gong)(gong)司位(wei)于淮安(an)市清浦工業園(yuan)區(qu)天士(shi)力淮安(an)生物醫(yi)藥(yao)(yao)(yao)產(chan)業園(yuan)。公(gong)(gong)司主要生產(chan)化(hua)學原料藥(yao)(yao)(yao)和口(kou)服固體制劑(ji)(片(pian)(pian)劑(ji)、膠(jiao)囊(nang)劑(ji)),產(chan)品(pin)(pin)主要涉及抗腫(zhong)瘤、心血(xue)管、精神類及保肝護肝用(yong)藥(yao)(yao)(yao)。化(hua)學原料藥(yao)(yao)(yao)有替莫(mo)唑(zuo)胺(an)、氟(fu)他胺(an)、尼可地爾、舒(shu)必利、水(shui)飛(fei)薊(ji)賓、苯扎貝特等12個(ge)品(pin)(pin)種(zhong),片(pian)(pian)劑(ji)、膠(jiao)囊(nang)劑(ji)品(pin)(pin)種(zhong)治(zhi)療(liao)前列(lie)腺癌的(de)(de)二類新(xin)藥(yao)(yao)(yao)氟(fu)他胺(an)片(pian)(pian)/膠(jiao)囊(nang),治(zhi)療(liao)失(shi)眠的(de)(de)二類新(xin)藥(yao)(yao)(yao)右佐(zuo)匹克隆片(pian)(pian)(文飛(fei))和治(zhi)療(liao)高血(xue)壓的(de)(de)四(si)類新(xin)藥(yao)(yao)(yao)賴(lai)諾普利膠(jiao)囊(nang)(帝(di)(di)益洛)等80余(yu)個(ge)產(chan)品(pin)(pin)。2019年初,公(gong)(gong)司產(chan)品(pin)(pin)替莫(mo)唑(zuo)胺(an)膠(jiao)囊(nang)(商品(pin)(pin)名“蒂清”)三(san)個(ge)規格通過仿制藥(yao)(yao)(yao)一致性評價。
公(gong)司占地323畝,具有年(nian)產(chan)300T的(de)化(hua)(hua)學(xue)原(yuan)料藥制(zhi)造平臺(抗腫瘤API和普(pu)通API)、年(nian)產(chan)22億片(粒)的(de)普(pu)通固(gu)(gu)體制(zhi)劑(ji)和抗腫瘤固(gu)(gu)體制(zhi)劑(ji)制(zhi)造平臺。公(gong)司還具有化(hua)(hua)學(xue)藥研(yan)(yan)發及產(chan)業(ye)化(hua)(hua)平臺。公(gong)司二(er)期工程無菌車間已(yi)達產(chan)業(ye)化(hua)(hua)生產(chan)水平。規劃建設(she)天士(shi)力研(yan)(yan)究院江蘇分(fen)院,滿(man)足日益增加的(de)新品研(yan)(yan)發及產(chan)業(ye)化(hua)(hua)需求,目(mu)前該項(xiang)目(mu)已(yi)啟動,預計2020年(nian)投入使用。
公司所有(you)劑型通過中國(guo)(guo)新(xin)版藥品GMP認(ren)(ren)證(zheng)(zheng),原(yuan)料藥先后(hou)通過歐盟GMP認(ren)(ren)證(zheng)(zheng)、韓國(guo)(guo)GMP認(ren)(ren)證(zheng)(zheng)、日本GMP認(ren)(ren)證(zheng)(zheng)。公司還通過了ISO14001環境管(guan)理體(ti)系(xi)認(ren)(ren)證(zheng)(zheng)、ISO9001質量管(guan)理體(ti)系(xi)、和(he)OHSAS18001職(zhi)業(ye)健康安全評價體(ti)系(xi)認(ren)(ren)證(zheng)(zheng)等。