Index of wp-content uploads 2017 08 12048 QLD ĐK VNRAS
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CONG HOA xX HOI CHU NGHiA Vl¢T NAM
DQc l~p - T1}' do - H~nh phuc
BOYTE
CVC QUAN LY DUQC
S6).20Lf t /QLD-DK
Ha N9i, ngay
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 trong mroc da:
diroc dp s6 dang ky
Kinh giri: Co
__
--'-
sa dang
ky, san xuftt thuoc trong mroc
Can cir Luat Diroc s6 105/2016/QH13
ngay 06/4/2016;
Can cir Nghi dinh s6 54/2017/ND-CP
ngay 08/5/2017;
Can cir cong van s6 049/TNM dS ngay 27/07/2017 cua Cong ty c6 phan duoc
pham Tenamyd vS viec sua cac s6 lieu bi sai trong 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 trong danh muc kern theo Cong van nay thay thS n9i dung
d6i voi 09 thuoc da cong b6 kern theo Cong van sf>520l/QLD-DK ngay 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:
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./.
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DANH MUC NGUYEN LIEU LAM THUOC DUaC PHEP NHAp KHA.U KHONG YEU cAu GIA.Y PHEP NHAp
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KHA.U THUOC SAN XUAT TRONG NUOC· DA DUQC cAp
DANG KY
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(Dinh kern cong van
AJt.'J. ... QLD-DK ngayA;f / P /2017)
so
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Thu6c
thanh phim
Nguyen
Ngay h~t
STT
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S6 giiy dang
ky
hru hanh thu6c
hi~u l,!c cua
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dan (J
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ky hru
1
2
3
4
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 8
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 8
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 8
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 8
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
6
TenamydCefuroxime 1500
VD - 19453 - 13
10109/2018
Cong ty CPDP
Tenamyd
7
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
8
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
9
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
