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B 0 Y TE C0NG HOA XA H 0I CHU NGHIA VIET NAMCUC QUAN LY DUGC Doc lap - Tu do - Hanh phuc
S603O /Q LD -D K Ha Noi, ngay ̂ thang Jj nam 2018V/v cong bo danh muc nguyen lieu lam thuoc dugc nhap khau khong phai thirc hien viec cap phep nhap
khau cua thuoc trong nuac da dugc cap SDK
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K in h gu i: C ac co so dang ky , san x u a t th u o c tro n g n u d e .
-Gan c u L u a t d u g c so 1 0 5 /2 0 1 6 /Q H 13 ngay 06 /4 /2016 ;C an cu* N g h i d in h 5 4 /2 0 17/N D -C P n g ay 08 /5 /2017 ;
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T heo de ng h i cu a co n g ty tai van th u so v an th u so 4 7 6 /C V -D N A de ng ay 30 /8 /2018 cua C o n g T y C P D u g c - V T Y T N g h e A n; v a n th u de n g ay 06 /9 /2018 cua C ong ty T N H H R e liv P h arm a; v an th u so 2 8 6 /2 0 1 8 /C V -S T A de n g ay 06 /9 /2018 , so 2 7 1 /2 0 1 8 /C V -S T A de n g ay 16/8 /2018 va so 2 8 4 /2 0 1 8 /C V -S T A de ngay 05 /9 /2018 cua C ong ty T N H H L ie n D o an h S T A D A -V IE T N A M ; v an th u so 881 /D K -D H T ngay 13/8 /2018 cu a C o n g ty C o p h an D u g c ph am H a T ay ; v an th u so 2 7 /M D -D K ngay 2 1 /8 /2018 cu a C o n g ty co p h an d u g c p h am M in h D an; v an th u so 22 /2018- C V , so 2 3 /2 0 18-C V , so 2 4 /2 0 18-C V ng ay 0 6 /9 /2018 cu a C o n g ty co p h an d u g c pham M ed b o lid e ; v an th u de ng ay 23 /8 /2018 cu a C o n g ty co p h an d u g c pham A m pharco U .S .A ; v an th u so 1134/PM P de n g ay 15 /8 /2018 cua C ong T y C o P h an P Y M E P H A R C O ;
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C ong bo D an h m u c n g u y en lieu lam th u o c de san x u a t th u o c th eo ho so dang ky thuoc da co g iay d an g ky lu u han h th u o c tai V ie t N am d u g c nh ap khau k h o n g phai thirc h ien v iec cap p h ep nh ap k h au theo danh m uc d in h kem .
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C ue Q uan ly D u g c th o n g bao de cac cong ty san x u a t b ie t v a th irc h ien .
Noi nhan:- Nhu tren;- CT. Vu Tuan Cirang (de b/c);- Tong Cue Hai Quan (de phoi hop);- Website Cue QLD; —'- Luu: VT, DK (Chi).
PHO. CUC TRUCJNG
ONG DANG KY THUOC
Nguyen Thi Thu Thuy
DANH MUCNGUYEN LIEU LAM THUOC LA Dl/OC CHAT, TA DlTOC, BAN THANH PHAM THUOC DE SAN XUAT THUOC THEO HO SO DANG KY
THUOC DA CO GlAY DANG KY LU'U HANH THUOC TAI VIET NAM DITQC NHAP KHAU KHONG PHAl THUC HIEN VIEC CAP PHEP NHAPk h Au
(Dinh kem Cong van so ■MJ.5.Q....../QLD-DK ngay c&5£3J£a{£l .cua Cue Quan ly Dirge)
STT T en thu6cSo giay dang ky luu hanh thuoc
N gay het hieu luc cua giay dang ky luu
hanh
T en co so san xuat thuoc
T en nguyen lieu lam thuoc
T C C L cua nguyen
lieu
T en c a s a san xuat nguyen lieu
D ia chi c a s a san xuat nguyen lieuT en n u a c san xuat nguyen
lieu
1 D eferox 125 V D -27583-17 22 /06 /2022C ong ty C 6 phan
D ugc pham T rung u o n g 2
D eferasirox N SXM SN L aboratories
P rivate L im ited
Sy.N o.317 & 323 , R udraram (v illage), Patancheru (M andal),
S angareddy (D istric t.) T elangana, P incode: 502329, India
India
2 C inarizin 25 m g V D -20921-14 12/06/2019C ong ty C P D ugc -
V T Y T N ghe A nC innarizine E P 9.0
R akshit D rugs P V T LTD.
S y N o . 10/B, G addapo tharam V illage, Jinnaram M andal, M edak
D istric . T .S , India.India
3 V inpocetin V D -20929-14 12/06/2019C ong ty C P D ugc -
V T Y T N ghe AnV inpocetine EP 8.0
N ortheastpharm aceutical G roup
C o., LTD
N o.29 Shenxiliu D ong R oad, E conom ic T echno logy D evelopm ent
D istric t, Shenyang,. P .R C hinaC hina
4 C arvestad 6.25 V D -29498-18 22/02 /2023C hi nhanh cong ty
T N H H Lien D oanh S T A D A -V IE T N A M
C arved ilo l E P 7.0 Sym ed Labs L im itedP lot N o. 25 /B , Phase - III, IDA,
Jeed im etla , H yderabad - 500 055, T elangana, India.
India
5 N ev itrio 30 V D -25034-16 15/07/2021C ong ty T N H H Lien
D oanh STA D A - V IE T N A M
S tavudine U S P 3 5 H etero L abs L im ited
Sy.N o. 1 0 ,1.D.A, G addapo tharam V illage, Jinnaram M andal,
S angareddy D istric t, T elangana State
India
6 V orifend Forte V D -27535-17 22 /06 /2022Chi nhanh C ong ty T N H H L ien D oanh
ST A D A -V IE T N A M
G lucosam ine sulfate po tassium ch loride
U S P 3 7Z hejiang Z houshan
Putuo X inx ing Pharm as C o., L td
Shunm u, Z hu jia jian S treet, Putuo D istric t, Z houshan C ity, Z hejiang
P rov inceC hina
7C etiriz ine
STA D A 10 m gV D -30834-18 05 /07/2023
Chi nhanh C ong ty T N H H L ien D oanh
S T A D A -V IE T N A M
C etiriz ined ihydroch lo ride
EP 8.0G lochem Industries
Pvt. Ltd.
Survey N os. 174 to 176, IDA, B ollaram , Sangareddy (D ist.) - 502
325 T elangana StateIndia
8D iosm in STA D A
500 m gV D -22349-15 09 /02 /2020
Chi nhanh cong ty T N H H L ien D oanh
S T A D A -V IE T N A M
D iosm in:H esperid in(90:10)
T C N SXC hengdu Y azhong Bio-
pharm aceu tical Co., L td
L ichun T ow n, P engzhou, S ichuan 611936
C hina
9C alcium STA D A
V itam in C, PPV D -25981-16 15/11/2021
C hi nhanh cong ty T N H H L ien D oanh
ST A D A -V IE T N A M
C alcium g lucohep tona te d ihydrate (C alcium
G lucohep tonate SO C )
U S P 3 5 G ivaudan L aviro tte56, rue Paul C azeneuve, 69008
L yonFrance
10 E lnitine V D -1 4 8 5 8 -1 1 29 /12 /2018Chi nhanh cong ty
T N H H L ien D oanh ST A D A -V IE T N A M
C alciumg lycerophosphate 50% (50% L iquid C alcium
G ly cerophosphate )
T C N SX G ivaudan-L av iro tte56 R ue Paul C azeneuve, 69008
LyonFrance
11 F luco ldstad V D -18109-12 06/02 /2019Chi nhanh cong ty
T N H H Lien D oanh S T A D A -V IE T N A M
Paracetam ol E P 8.0 S pecG x LLC8801 C apita l B oulevard , R aleigh,
N C 27616-3116U SA
12 Partam ol 250 V D -18852-13 01 /04 /2019Chi nhanh cong ty
T N H H L ien D oanh S T A D A -V IE T N A M
P aracetam ol E P 8.0 S pecG x LLC8801 C ap ita l B oulevard , R aleigh,
N C 27616-3116U SA
13 Partam ol 325 V D -21536-14 12/08/2019Chi nhanh cong ty
T N H H L ien D oanh S T A D A -V IE T N A M
P aracetam ol EP 7.0 S pecG x LLC8801 C apita l B oulevard , Raleigh,
N C 27616-3116U SA
14 Partam ol 80 V D -23977-15 17/12/2020Chi nhanh cong ty
T N H H Lien D oanh ST A D A -V IE T N A M
P aracetam ol EP 7.0 S pecG x LLC8801 C apita l B oulevard , Raleigh,
N C 27616-3116U SA
M
15 Partam ol extra V D -30837-18 05/07 /2023C ong ty T N H H Lien
D oanh STA D A - V IE T N A M
Paracetam ol EP 8.0 SpecG x LLC8801 C apita l B oulevard , R aleigh,
N C 27616-3116USA
16 P artam ol-C odein V D -29504-18 22 /02/2023Chi nhanh cong ty
T N H H Lien D oanh ST A D A -V IE T N A M
P aracetam ol EP 8.0 SpecG x LLC8801 C apital B oulevard , R aleigh,
N C 27616-3116U SA
17 H em arexin V D -16718-12 19/07/2019C hi nhanh cong ty
T N H H Lien D oanh ST A D A -V IE T N A M
Ferrous G luconate (G IV O B IO Fe 601)
E P 8.0 G i vaudan-L av iro tte56 Rue Paul C azeneuve, 69008
L yon France
18 H em arexin V D -16718-12 19/07/2019C hi nhanh cong ty
T N H H Lien D oanh ST A D A -V IE T N A M
M anganese G luconate U S P 3 8 G ivaudan-L av iro tte56 Rue Paul C azeneuve, 69008
Lyon France
19 H em arexin V D -16718-12 19/07/2019C hi nhanh cong ty
T N H H Lien D oanh ST A D A -V IE T N A M
C opper G luconate (G IV O B IO G cu)
U S P 3 8 G ivaudan-L av iro tte56 Rue Paul C azeneuve, 69008
Lyon France
20A llopurinol
STA D A 300 m gV D -23985-15 17/12/2020
Chi nhanh cong ty T N H H Lien D oanh
ST A D A -V IE T N A MA llopurino l E P 8.0
Y ix ing C ity X ingyu M edicine C hem icals
C o., Ltd.
Fangqiao T ow n Industria l Park, Y ix ing C ity, Jiangsu P rovince
214200C hina
21 Indopril 5 V D -26574-17 06 /02 /2022C hi nhanh cong ty
T N H H Lien D oanh S T A D A -V IE T N A M
Im idapril hydroch lo ride N SXSM S Pharm aceu tica ls
L im ited
U nit-II, P lo t N o .24 & 24B and 36 & 37 S.V . C o-O pera tive Industrial E state B achupally , R anga R eddy distric t, H yderabad , T elangana -
500090
India
22L oratadin
STA D A 10 m gV D -23354-15 09 /09 /2020
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S T A D A -V IE T N A ML oratad ine U S P 3 5
C ad ila P harm aceutica ls L im ited
294 , G .I.D .C ., E state, A nkleshw ar- 393 002, G u jara t
India
23M agne-B 6
STA D AV D -23355-15 09 /09 /2020
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ST A D A -V IE T N A M
V itam in B6 (Pyridoxine
hydrochloride)U S P 3 8
Jiangxi T ianxin P harm aceu tica l Co.,
Ltd.
L eanjiang Industria l Z one, L eping, Jiangxi, 333300
C hina
I r ~ ! ; ' d
24 Stadleucin V D -27543-17 22/06 /2022C hi nhanh cong ty
T N H H L ien D oanh ST A D A -V IE T N A M
A cety lleucine T C N S X C entipharmC hem in de la M adeleine, F -06130
G rasseFrance
25 S canneuron-Forte V D -2 2 0 13-14 08/12 /2019Chi nhanh cong ty
T N H H L ien D oanh S T A D A -V IE T N A M
V itam in B6 (P yridoxine
hydroch lo ride)U S P 3 5
Jiangxi T ianxin Pharm aceutica l Co.,
Ltd.
L ean jiang Industrial Z one, L eping, Jiangxi, 333300
C hina
26P redniso lone STA D A 5 m g
V D -2 1537-14 12/08/2019C ong ty T N H H Lien
D oanh STA D A - V IE T N A M
P redn iso lone U S P 3 8T ian jin T ianyao
Pharm aceutica ls C o., Ltd.
N o. 19, X inye 9th S treet, W es A rea o f T itan jin E conom ic -
T echno log ica l D evelopm ent A rea, T ian jin , 300462.
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C hina
27 Stadgentri V D -23363-15 09/09 /2020C ong ty T N H H Lien
D oanh STA D A - V IE T N A M
B etam ethasoned ip rop iona te
U S P 3 8T ian jin T ianyao
Pharm aceutica ls Co., Ltd.
N o . 19, X IN Y E 9th S treet, W est A rea o f T ian jin E conom ic-
T echno log ica l D evelopm ent A rea, T ian jin 300462
C hina
28 S tadgentri V D -23363-15 09 /09/2020C ong ty T N H H Lien
D oanh STA D A - V IE T N A M
G entam icin sulphate sterile
EP 8.0
Fuan P harm aceutical G roup Y antai
Justaw arePharm aceutica l Co.,
Ltd.
N o. 1 Y anfu R oad, Z hifu D istric t, Y antai C ity, Shandong P rov ince
C hina
29 M idalex in 250m g V D -24232-16 23/03/2021C ong ty co phan dirge pham M inh
D an
C ephalex inm onohydrate
D D V N IVN orth C hina
P harm aceu tica l Co., Ltd.
N o. 18, Y angzi R oad, S h ijiazhuang E conom ic
& T echnolog ical D evelopm ent Z one, H ebei
C hina
30 H acold V D -22149-15 09/02 /2020C ong ty co phan
d u g c pham H a T ayParacetam ol B P 2016
A nqiu Luan Pharm aceutica l Co.,
Ltd
N o. 35, W eixu N orth R oad, A nqiu city , Shandong p rovince , C hina.
C hina
31
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Sovasdi V D -26183-17 06/02 /2022C ong ty co phan
B iroc pham M e B i Sun
L inezolid N SXG lenm ark
Pharm aceu tica ls Ltd.
P lo t N o A -80, M IB C A rea K urkum bh, T aluka B aund, B istric t Pune, 413802 , M aharashtra , India
India
32 D A G O C T I V D -25204-16 05/09/2021
C hi nhanh C ong ty co phan B iroc pham
Phong Phu - N ha m ay san xuat B u g c
phamU SA R IC H P H A R M
B utaste ride N SX S T E R L IN G S.p.A .V ia della C arboneria, 30 -
06073 Solom eo di C orciano - P erug ia - Italy
Italy
33 G E FB IN V D -22186-15 09/02 /2020C ong ty co phan
B u g c pham M e B i Sun
E bastine EP8B A L PH A R M A
L IM IT E B61-B , B om m asandra Industrial A rea,
B angalore - 560 099, IndiaIndia
34 M axxtrude Q L B B -597-17 22 /06 /2019C ong ty co phan
d u g c pham A m pharco U .S .A
T enofov irB isoprox il Fum arate IP 7.0
A nhui B iochem P harm aceutica l Co.,
L td
Z one B, Innovation A venue, T aihe Industrial Park, A nhui P rovince,
C hinaC hina
35 Fap inv ir 125m g Q L B B -675-18 27/03/2021C ong T y C o Phan P Y M E P H A R C O
F am ciclov ir U S P 3 9 H etero B rugs L im ited
S .N o.s, 213 , 214 & 255, B on thapally V illage, Jinnaram M andal, M edak B istric t, A ndhra P radesh
IN B IA
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