Công văn 13191/QLD-ĐK năm 2018 công bố danh mục nguyên liệu làm thuốc được nhập khẩu không phải thực hiện việc cấp phép nhập khẩu của thuốc trong nước đã được cấp số đăng ký do Cục Quản lý Dược ban hành

BỘ Y TẾ
CỤC QUẢN LÝ DƯỢC
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CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập - Tự do - Hạnh phúc
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Số: 13191/QLD-ĐK
V/v công bố danh mục nguyên liệu làm thuốc được nhập khẩu không phải thực hiện việc cấp phép nhập khẩu của thuốc trong nước đã được cấp SĐK

Hà Nội, ngày 11 tháng 07 năm 2018

Nơi nhận:
- Như trên;
- CT. Vũ Tuấn Cường (để b/c);
- Tổng Cục Hải Quan (để phối hợp);
- Website Cục QLD;
- Lưu: VT, ĐKT (TTr).

TUQ. CỤC TRƯỞNG
PHÓ TRƯỞNG PHÒNG ĐĂNG KÝ THUỐC




Nguyễn Thị Thu Thủy

STT

Tên thuốc

Số giấy đăng ký lưu hành thuốc

Ngày hết hiệu lực của giấy đăng ký lưu hành

Tên cơ sở sản xuất thuốc

Tên nguyên liệu làm thuốc

Tiêu chuẩn chất lượng của nguyên liệu

Tên cơ sở sản xuất nguyên liệu

Địa chỉ cơ sở sản xuất nguyên liệu

Tên nước sản xuất nguyên liệu

1

Travicol codein

VD-15008-11

13/12/2018

Công ty CPDP TV.Pharm

Paracetamol (Acetaminophen)

BP 2014

Anqiu Lu’an Pharmaceutical Co., Ltd.

No.35, Weixu North Road, Anqiu City, Shandong Province

China

2

Captopril

VD-17567-12

13/12/2018

Công ty CPDP TV.Pharm

Captopril

USP38

Changzhou Pharmaceutical Factory

No.518 Laodong East Road, Changzhou city

China

3

Desloratadin

VD-17570-12

13/12/2018

Công ty CPDP TV. Pharm

Desloratadin

USP 38, Ph.Eur 8, In- house

Vasudha pharma Chem Limited

Unit-I, Plot No. 39 A & B Jeedimetla, Hydrabad - 500 055, Telangana

India

4

Dextromax

VD-17571-12

13/12/2018

Công ty CPDP TV.Pharm

Dextromethorphan hydrobromide

BP 2014/ Ph.Eur 8

Vasudha pharma Chem Limited

Unit-II, Plot No.79, J.N Pharma city, Thanam village, Parawada mandal, Visakhapatnam district, Andhra Pradesh

India

5

Dextromethorphan

VD-17572-12

13/12/2018

Công ty CPDP TV. Pharm

Dextromethorphan hydrobromide

USP40

Wockhardt Limited

Plot No. 138, GIDC Estate, Ankleshwar -393002. Dist. Bharuch, Gujarat.

India

6

Dextromethorphan 15mg

VD-17573-12

13/12/2018

Công ty CPDP TV.Pharm

Dextromethorphan hydrobromide

USP40

Divi's Laboratories Limited

Unit-I, Lingojigudem Village, Choutuppal Mandal, Nalgonda District - 508 252, Telangana,

India

7

Iburax 500mg

VD-17575-12

13/12/2018

Công ty CPDP TV.Pharm

Acid mefenamic

NSX

Shangyu Forever Chemical Co.,Ltd

Jing Wu Road, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, China

China

8

Isoniazid

VD-17576-12

13/12/2018

Công ty CPDP TV.Pharm

Isoniazid

USP 29

SECOND PHARMA CO., LTD.

Hungzhou Gulf Fine Chemical Zone, Shangyu City, Zhejiang Province

China

9

Mefenamic 500mg

VD-17577-12

13/12/2018

Công ty CPDP TV.Pharm

Acid mefenamic

NSX

Shangyu Forever Chemical Co.,Ltd

Jing Wu Road, Hangzhou Gulf Fine Chemical Zone, Shangyu, Zhejiang, China

China

10

Spasticon

VD-17578-12

13/12/2018

Công ty CPDP TV.Pharm

Piracetam

EP 8/ EP 9

Jiangxi Yuehua Pharmaceutical Co. Ltd.

No.58, Changxi road, Jingdezhen city, Jiangxi province

China

11

Spasticon

VD-17578-12

13/12/2018

Công ty CPDP TV.Pharm

Cinnarizine

BP 2014, Ph.Eur 8.0

Flemming Laboratories Limited

Survey No. 270 Nawabpet(V), Shivampet(M), Medak district, Telangana State

India

12

Aztram

VD-17580-12

13/12/2018

Công ty CPDP TV.Pharm

Piracetam

EP 8/EP 9

Jiangxi Yuehua Pharmaceutical Co. Ltd.

No.58, Changxi road, Jingdezhen city, Jiangxi province

China

13

Aztram

VD-17580-12

13/12/2018

Công ty CPDP TV.Pharm

Cinnarizine

BP2014

RL FineChem PVT. Ltd

1/ Factory address: No. 41 KHB Industrial Area, Yelahanka, Bengaluru, Karnataka State (Bangalore), Pin-560064

2/No. 15 KHB Industrial Area, Yelahanka, Bengalurru (Bangalore) - 560064

India

14

Traforan 1g

VD-17581-12

13/12/2018

Công ty CPDP TV. Pharm

Cefotaxime sodium

USP38

NCPC Hebei Huamin Pharmaceutical Co. Ltd,

No.98 Hainan Road, Economic & Technological Development Zone, Shijiazhaung

China

15

Travinat 750mg

VD-17582-12

13/12/2018

Công ty CPDP TV. Pharm

Cefuroxime sodium

USP38

Qilu Antibiotics Pharmaceutical Co. Ltd.

No.849 Dongjia Town, Licheng District, China-250 105 Jinan, Shandong province

China

16

TV-Ceftri 1g

VD-17583-12

13/12/2018

Công ty CPDP TV.Pharm

Ceftriaxone sodium

USP38

Qilu Antibiotics Pharmaceutical Co. Ltd.

No.849 Dongjia Town, Licheng District, China-250 105 Jinan, Shandong province

China

17

TV-Droxil

VD-17584-12

13/12/2018

Công ty CPDP TV.Pharm

Cefadroxil monohydrat

BP 2015

Lupin Limited

1/Works: Plot No. 09, 123, 123/1, 124 & 125, GIDC Estate, Ankleshwar 393002 (Gujarat);

2/ Rest Office: Kalpataru Inspire, 3rd floor, Santacruz 159, C.S.T.Road, Kalina, Santacruz (East), Mumbai - 400 055. (Maharashtra), India.

India

18

TV.Ladine

VD-17585-12

13/12/2018

Công ty CPDP TV. Pharm

Lamivudine

NSX

Taizhou ignore bio­-tech co. ltd

Factory: Huatao, Tiantai county, Zhejiang.Sales Office: Yuantian technology mansion, Binjiang, Hangzhou Taizhou Zhejiang China

China

19

Viên ngậm Vitamin C

VD-17586-12

13/12/2018

Côngty CPDP TV.Pharm

Acid ascorbic

BP 2014

Aland (jiangsu) nutraceutical co.,ltd.

61 Jiangshan Road, Jingjiang, 214500, JIANGSU, Jiangsu

China

20

Vitraclor

VD-17587-12

13/12/2018

Công ty CPDP TV.Pharm

Cefaclor

USP 38

Lupin Limited

Works: Unit-I. 198-202 New Industrial Area No. 2, Mandideep - 462046, district Raisen [M.P], India

India

21

Cefdinir

VD-17986-12

08/01/2019

Công ty CPDP TV.Pharm

Cefdinir

USP 35

Nectar Lifesciences Ltd.

1/SCO-38, 39, Sector 9-D Chandigarh-160 009;

2/ Regd. Office & works: Vill. Saidpura Tehsil - Derabassi district, Mohali (Pb)

India

22

Cefdinir

VD-17985-12

08/01/2019

Công ty CPDP TV.Pharm

Cefdinir

USP38

Qilu Antibiotics Pharmaceutical Co. Ltd.

No.849 Dongjia Town, Licheng District, Jinan

China

23

Eucatusdin

VD-17987-12

08/01/2019

Công ty CPDP TV. Pharm

Eucalyptol

DĐVN IV

Tien yuan chemical (pte) ltd

NO. 18 CHIN BEE ROAD, JURONG TOWN

Singapore

24

Eucatusdin

VD-17987-12

08/01/2019

Công ty CPDP TV. Pharm

Menthol

DĐVN IV

Tien yuan chemical (pte) ltd.

NO, 18 CHIN BEE ROAD, JURONG TOWN,

Singapore

25

Loratadine

VD-17988-12

08/01/2019

Công ty CPDP TV.Pharm

Loratadine

USP 40

Vasudha pharma Chem Limited

Unit-II, Plot No.79, Jawaharlal Nehru Pharma city, Thanam village, Parawada mandal, Visakhapatnam district, Andhra Pradesh, India

India

26

TV.Cefalexin 250 mg

VD-17989-12

08/01/2019

Công ty CPDP TV.Pharm

Cefalexin monohydrate

Ph.Eur 8.0, USP38, BP2014, IP2010, ChP2015

DSM Sinochem Pharmaceuticals (Zibo) Co., Ltd.

No. 1033, Mu Long Shan road, High-Tech zone, Zibo, Shandong province

China

27

B-coenzyme

VD-15845-11

08/01/2019

Công ty CPDP TV. Pharm

Vitamin B1 (Thiamine nitrate)

BP2016/ USP39

Dafeng Brother Pharmaceutical Co. Ltd.

South of Weier road, Southern area Ocean Economic Development Zone, Dafeng city, Yancheng, Jiangsu

China

28

B-coenzyme

VD-15845-11

08/01/2019

Công ty CPDP TV.Pharm

Vitamin B2 (Riboflavin)

USP39

Chifeng Pharmaceuticals Co., Ltd.

No. 84 Yidong street, Hongshan district, Chifeng (inner Mongolia 02 4001)

China

29

B-coenzyme

VD-15845-11

08/01/2019

Công ty CPDP TV.Pharm

Vitamin B5 (Calcipantothenat)

DĐVN IV

DSM Nutritional Products

32 Pasir Panjang Road, Mapletree Business City #13-31 Singapore 117440

Singapore

30

B-coenzyme

VD-15845-11

08/01/2019

Công ty CPDP TV.Pharm

Vitamin B6 (Pyridoxin.HCl)

BP 2007

Jiangxi Tianxin Pharmaceutical Co.,Ltd.

33 Pasir Panjang Road, Mapletree Business City #13- 31 Singapore 117440

Singapore

31

B-coenzyme

VD-15845-11

08/01/2019

Công ty CPDP TV.Pharm

Vitamin PP (Nicotinamid)

DĐVN IV

DSM Nutritional Products

34 Pasir Panjang Road, Mapletree Business City #13-31 Singapore 117440

Singapore

32

Ibuprofen

VD-15472-11

08/01/2019

Công ty CPDP TV.Pharm

Ibuprofen

EP8

Shandong Xinhua Pharmaceutical Co., Ltd.

1/ East Chemical Zone of Zibo High & New Technology Development Zone, Zibo, Shandong;

2/ Hutian Chemical Industrial Zone, Zobo, Shandong

China

33

TV-Tussine

VD-15208-11

08/01/2019

Công ty CPDP TV.Pharm

Guaifenesin

USP37/ USP38/ USP39

Zhejiang Haizhou Pharmaceutical Co., Ltd

Yanhai Industrial Zone, Linhai city, Zhejiang

China

34

TV-Tussine

VD-15208-11

08/01/2019

Công ty CPDP TV.Pharm

Dextromethorphan.H Br

USP40

Wockhardt Limited

Plot No. 138, GIDC Estate, Ankleshwar -393002. Dist. Bharuch, Gujarat

India

35

TV-Tussine

VD-15208-11

08/01/2019

Công ty CPDP TV.Pharm

Dexchlorpheniramin maleat

USP 37

NiveditaChemicals PVT.LTD

A-14, M.I.D.C, Andheri (East), Mumbai - 400 093, Maharashtra

India

36

Vitamin B6

VD-15856-11

08/01/2019

Công ty CPDP TV. Pharm

Vitamin B6 (Pyridoxin.HCl)

BP2007

Jiangxi Tianxin Pharmaceutical Co.,Ltd.

No.215 Fengze Road, Tiantai, Zhejiang

China

37

Novazine

VD-15474-11

08/01/2019

Công ty CPDP TV.Pharm

Paracetamol (Acetaminophen)

BP 2014

Anqiu Lu’an Pharmaceutical Co., Ltd.

No.35, Weixu North Road, Anqiu City, Shandong Province

China

38

Cefadroxil TVP 250mg

VD-11745-10

08/01/2019

Công ty CPDP TV.Pharm

Cefadroxil monohydrate

Ph.Eur 8.0/ BP 2014/ USP 38/ IP2010

DSM Sinochem Pharmaceuticals Spain S.A.

Calle Ripolles, 2 Poligono Industrial Urvasa, Santa Perpetua De Mogoda, 08130 Barcelona

Spain

39

Terpinzoat

VD-12977-10

08/01/2019

Công ty CPDP TV.Pharm

Sodium benzoat powder

USP 29

Emerald Performance Material - USA

Materials 240 W Emerling Ave Akron, OH,

USA

40

Magnesium-B6

VD-12972-10

08/01/2019

Công ty CPDP TV.Pharm

Pyridoxine Hydrochlorid (Vitamin B6)

BP2015/ USP38

Dafeng Hegno Pharmaceuticals Co. Ltd.

South district, Ocean Economy Development area of Dafeng, (Yancheng city), Jiangsu province, China.

China

41

D- Cotatyl 500

VD-13526-10

08/01/2019

Công ty CPDP TV.Pharm

Mephenesin

BPC73

Synkothem Labs Private Limited

Unit II- Plot No. 222 to 224 and 235 to 237, Phase II, IDA, Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana State;

India

42

Spacmarizine

VD-12432-10

08/01/2019

Công ty CPDP TV.Pharm

Alverine citrate

EP8

Yancheng Chemhome Chemical Co. Ltd (NSX bổ sung - không có GMP)

No.91 Kaifang street Yancheng Jiangsu

China

43

Myantacid - II

VD-12973-10

08/01/2019

Công ty CPDP TV. Pharm

Simethicon

BP 2007

N medics co., ltd

Dong, guro-ku, seoul, 152- 050, Korea

Korea

44

Travimuc

VD-13917-11

08/01/2019

Công ty CPDP TV.Pharm

Acetylcystein

BP 2007

Wuhan Grand Hoyo Co., Ltd

No. 399, Luo Yu Road, Zhuo Dao Quan, Wuhan, HB 430070 China

China

45

D-Cotatyl 250

VD-15846-11

08/01/2019

Công ty CPDP TV.Pharm

Mephenesin

BPC73

Samanta Organics PVT. LTD.,

T-119 M.I.D.C, Tarapur, Boisar, district Thane - 401506

India

46

Stugon - pharimex

VD-15848-11

08/01/2019

Công ty CPDP TV.Pharm

Cinarizine

BP 2014/ Ph.Eur 8.0

Flemming Laboratories Limited

Survey No. 270 Nawabpet(V), Shivampet(M), Medak district, Telangana State,

India

47

Novazine

VD-15473-11

08/01/2019

Công ty CPDP TV. Pharm

Paracetamol

BP 2014

Anqiu lu’an pharmaceutical co., ltd

No.35, Weixu North Road, Anqiu City, Shandong Province

China

48

Terpinzoat

VD-15852-11

08/01/2019

Công ty CPDP TV.Pharm

Sodium benzoat powder

BP2013/EP8/ USP38/NF33

Wuhan YouJi Industries Co, Ltd.

No.1, 2nd Chemical Rd., Wuhan Chemical Industry Park, Wuhan 430082 China

China

49

Butylpan

VD-16288-12

01/08/2018

Công ty CPDP TV.Pharm

Hyoscine N- Butylbromide

EP8 / BP2015

Vital Laboratories Private Limited

1/ Plot No. 1710 & A1/2208 GIDC Estate, Phase III, VAPI 396-195, Gujarat

2/ 2nd floor, Plot No.48, Service road, Western Express Highway, Near Hanuman Temple, Vile Parle (East), Mumbai - 400 057.

India

50

Flumax

VD-16606-12

01/08/2018

Công ty CPDP TV. Pharm

Paracetamol

BP2014

Anqiu Lu’an Pharmaceutical Co., Ltd.

No.35, Weixu North Road, Anqiu City, Shandong Province

China

51

Flumax

VD-16606-12

01/08/2018

Công ty CPDP TV. Pharm

Clorpheniramin maleate

USP38

Supriya Lifescience Ltd.

A-5/2, Lote Parshuram Industrial Area, M.I.D.C, Tal. Khed, Dist. Ratnagiri - 415 722,

India