CONG HOA xX HOI CHU NGHiA Vl¢T NAM DQc l~p - T1}' - H~nh phuc BOYTE CVC QUAN LY DUQC S6).20Lf t /QLD-DK Ha N9i, v Iv dinh chinh )1 thdng "2 ruim 2017 danh muc nguyen lieu diroc chat lam thuoc duoc phep nhap kh~u khong yeu du GPNK cua thuoc mroc da: diroc dp s6 dang ky Kinh giri: Co '- sa dang ky, san xuftt thuoc mroc Can cir Luat Diroc s6 105/2016/QH13 06/4/2016; Can cir Nghi dinh s6 54/2017/ND-CP 08/5/2017; Can cir cong van s6 049/TNM dS 27/07/2017 cua Cong ty c6 phan duoc pham Tenamyd vS viec sua cac s6 lieu bi sai cong b6 danh muc nguyen lieu dircc chat duoc phep nhap khau khong yeu cAu gifty phep nhap khau; 01 C\lC Quan ly Duoc thong bao: Cong b6 Danh rnuc nguyen lieu lam thuoc d~ san xuftt thuoc theo h6 sa dang ky thuoc da co giay dang ly luu hanh thuoc tai Viet Nam diroc nhap khau khong phai thirc hien viec cftp phep nhap khau (Danh muc dinh kern) N9i dung dinh chinh danh muc kern theo Cong van thay thS n9i dung d6i voi 09 thuoc da cong b6 kern theo Cong van sf>520l/QLD-DK 20104/2017 cua C\lC Quan ly Diroc, Danh muc nguyen lieu duoc chftt duoc cong b6 neu tren dang tai tren trang thong tin di~n tir cua C\lC Quan Iy Diroc tai dia chi: http://www.dav.gov.vn C\lC Quan ly Duoc thong bao Noi nlt(m: - Nhu tren; - TT Truong Quoc Cirong (d6 b/c); - T6ng C\lC Hili Quan (d6 ph6i hop); - Website cua C\lC QLD; /' - Luu: VT, DKT (DT) d0 co sa biet va thuc hi~n./ KT CVC TRUONG ~Pm~VCTRU6NG ) lf~!.Ii':! I ( ••• •• \J '>"'."i{)~ " ,.,\." ) ""-',y \ " ~, JI.: -0,\\,." -,I1:t'< ,'-< DANH MUC NGUYEN LIEU LAM THUOC DUaC PHEP NHAp KHA.U KHONG YEU cAu GIA.Y PHEP NHAp KHA.U THUOC SAN XUAT TRONG NUOC· DA DUQC cAp DANG KY (Dinh kern cong van AJt.'J QLD-DK ngayA;f / P /2017) so sa ) Thu6c phim Nguyen Ngay h~t STT Ten thudc S6 giiy dang ky hru hanh thu6c hi~u l,!c cua (Jiiy dan (J I:> I:> ky hru Taxibiotic 1000 Zidimbiotic 500 Zidimbiotic 1000 Zidimbiotic 2000 VD - 19007 - 13 VD - 19937 - 13 VO - 19012 - 13 VD - 19013 - 13 li~u hoat chit Tieu chuin Ten coosO' san xuit thu6c Ten nguyen Ii~u lam thu6c hanh Ten nU'(Yc chit IUQ'Ilg Ten coosO' san xuit cua nguyen nguyen Ii~u Dia chi coosO' san xuit nguyen li~u li~u USP 37, USP sodium sterile 38, EP nguyen Ii~u Nectar Lifesciences Ltd Sco-38, Sector 9-D 19106/2018 C6ng ty CPDP Tenamyd 0811112018 C6ng ty CPOP Tenamyd Ceftazidime pentahydrate sterile buffered USP 37, USP 38, EP Capitale Sociale € Fresenius Kabi Anti - 2.704.000 - R.E.A.Milano Infectives S.r.l 918726 - Tribunale Di Milano 165606 - Italia Italy 19/6/2018 Cong ty CPOP Tenamyd Ceftazidime pentahydrate sterile buffered USP 37, USP 38, EP Capitale Sociale € Fresenius Kabi Anti- 2.704.000 - R.E.A.Milano Infectives S.r.l 918726 - Tribunale Di Milano 165606 - Italia Italy C6ng ty CPDP Tenamyd Ceftazidime pentahydrate sterile buffered USP 37, USP 38, EP Capitale Sociale € Fresenius Kabi Anti - 2.704.000 - R.E.A.Milano Infectives S.r.l 918726 - Tribunale Di Milano 165606 - Italia Italy 19/6/2018 Cefotaxime san xuit Chandigarh -160 009 India India ~ Tenamyd Cefuroxime 750 VD - 19452 - 13 10109/2018 Cong ty CPDP Tenamyd Cefuroxime sodium sterile Cefuroxime so4n sterile USP 37, USP 38 ~ - o ~Sl37; - Nectar Lifesciences Ltd Sco-38, Sector 9-D Chandigarh -160 009India' India Shenzhen Salubris Pharmaceuticals Co., Ltd - China 1, Fenghuanggang Huabao Industrial District, Xixiang, Baoan District, Shenzhen, China China TenamydCefuroxime 1500 VD - 19453 - 13 10109/2018 Cong ty CPDP Tenamyd TenamydCeftazidime 500 VD -19444-13 10109/2018 Cong ty CPDP Tenamyd Ceftazidime with sodium carbonate sterile USP 37, USP 38 Qilu Antibiotics Pharmaceutical Co., Ltd No.849 Dongjia Town, Licheng Dist, Jinan, China China Tenamyd Ceftazidime 1000 VD - 19447 - 13 10109/2018 Cong ty CPDP Tenamyd Ceftazidime with sodium carbonate sterile USP 37, USP 38 Qilu Antibiotics Pharmaceutical Co., Ltd No.849 Dongjia Town, Licheng Dist, Jinan, China China Tenamyd Ceftazidime 2000 YO - 19448 - 13 10109/2018 Cong ty CPDP Tenamyd Ceftazidime with sodium carbonate sterile USP 37, USP 38 Qilu Antibiotics Pharmaceutical Co., Ltd No.849 Dongjia Town, Licheng Dist, Jinan, China China 38 ... NHAp KHA.U THUOC SAN XUAT TRONG NUOC· DA DUQC cAp DANG KY (Dinh kern cong van AJt.'J QLD- DK ngayA;f / P /2017) so sa ) Thu6c phim Nguyen Ngay h~t STT Ten thudc S6 giiy dang ky hru hanh thu6c... sterile 38, EP nguyen Ii~u Nectar Lifesciences Ltd Sco-38, Sector 9-D 19106/2018 C6ng ty CPDP Tenamyd 081 1112018 C6ng ty CPOP Tenamyd Ceftazidime pentahydrate sterile buffered USP 37, USP 38, EP Capitale