6
B0 Y TE C0NG HOA XA H0I CHU NGHIA VIET NAM CUC QUAN LY DUGC Doc lap - Tu do - Hanh phuc S603O /QLD-DK Ha Noi, ngay^thang Jj nam2018 V/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 r r Kinh gui: Cac co so dang ky, san xuat thuoc trong nude. -Gan cu Luat dugc so 105/2016/QH13 ngay 06/4/2016; Can cu* Nghi dinh 54/2017/ND-CP ngay 08/5/2017; r o a n 't r r r Can cu ket qua tham dinh ho so thay doi, bo sung doi vdi thuoc san xuat r r trong nude da dugc cap so dang ky luu hanh; > r r \ Theo de nghi cua cong ty tai van thu so van thu so 476/CV-DNA de ngay 30/8/2018 cua Cong Ty CP Dugc - VTYT Nghe An; van thu de ngay 06/9/2018 cua Cong ty TNHH Reliv Pharma; van thu so 286/2018/CV-STA de ngay 06/9/2018, so 271/2018/CV-STA de ngay 16/8/2018 va so 284/2018/CV-STA de ngay 05/9/2018 cua Cong ty TNHH Lien Doanh STADA-VIET NAM; van thu so 881/DK-DHT ngay 13/8/2018 cua Cong ty Co phan Dugc pham Ha Tay; van thu so 27/MD-DK ngay 21/8/2018 cua Cong ty co phan dugc pham Minh Dan; van thu so 22/2018- CV, so 23/2018-CV, so 24/2018-CV ngay 06/9/2018 cua Cong ty co phan dugc pham Medbolide; van thu de ngay 23/8/2018 cua Cong ty co phan dugc pham Ampharco U.S.A; van thu so 1134/PMP de ngay 15/8/2018 cua Cong Ty Co Phan PYMEPHARCO; Cue Quan ly Dugc thong bao: f r •? r r > Cong bo Danh muc nguyen lieu lam thuoc de san xuat thuoc theo ho so dang ky thuoc da co giay dang ky luu hanh thuoc tai Viet Nam dugc nhap khau khong phai thirc hien viec cap phep nhap khau theo danh muc dinh kem. r r Danh muc nguyen lieu lam thuoc dugc cong bo neu tren dang tai tren trang thong tin dien tu* cua Cue Quan ly Dugc tai dia chi: www.dav.gov.vn. •> r r Cue Quan ly Dugc thong bao de cac cong ty san xuat biet va thirc hien. 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

Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

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

r r

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 ;

r o a n 't r r r

C an c u k e t q u a th am d inh ho so th ay doi, bo su n g doi v d i thu o c san x u a tr r

trong n u d e da d u g c cap so dang ky lu u hanh;> r r \

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 ;

C ue Q u an ly D u g c th o n g bao:f r •? r r >

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 .

r r

D an h m uc n g u y en lieu lam th u o c d u g c cong bo n eu tren dang tai tren tran g tho n g tin d ien tu* cu a C ue Q u an ly D u g c tai d ia chi: w w w .d av .g o v .v n .

•> r r

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

Page 2: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

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

Page 3: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

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

Page 4: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

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

C hi nhanh cong ty T N H H Lien D oanh

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

C hi nhanh cong ty T N H H Lien D oanh

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

Page 5: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

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.

(So 19, d u o n g X inye 9th, K hu vuc phat trien K inh t§ - K y thua t T ay T h ien T an, T hien T an 300462)

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

Page 6: Ha Noi, ngay ^thang Jj nam 2018€¦ · potassium chloride USP37 Zhejiang Zhoushan Putuo Xinxing Pharmas Co., Ltd Shunmu, Zhujiajian Street, Putuo District, Zhoushan City, Zhejiang

31

»

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

j r