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(1)

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(2)

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(3)

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(4)

Tên NSX

(5)

Dược chất (ghi đầy đủ tên, dạng nguyên liệu, dạng muối...)

(6)

Tiêu chuẩn

(7)

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(8)

Địa chỉ cơ sở sản xuất

(9)

Nước sản xuất (10)

1

Acarsel 50

VD-26488-17

06/2/2022

Công ty Roussel Việt Nam

Acarbose

EP7

Hangzhou Viwa Co., Ltd

Room 503, Jiahua International Business Center, No. 15 Hangda Road, Hangzhou, 310007

China

2

Allopsel 300

VD-27426-17

22/6/2022

Công ty Roussel Việt Nam

Allopurinol

EP7

Union Quimico Farmaceutica S.A

Polig. Ind. Moli' de les Planes, C/Font de Bocs, s/n^o 08470 Sant Celoni (Barcelona)

Spain

3

Ambroxol RVN

VD-26489-17

06/2/2022

Công ty Roussel Việt Nam

Ambroxol hydroclorid

EP7

Hangzhou Deli Chemical Co., Ltd

RM. 1115, Jingui Mansion, No 387, Gudun Road, Xihu District, Hangzhou

China

4

Cinnarizine RVN

VD-27427-17

22/6/2022

Công ty Roussel Việt Nam

Cinnarizine

EP7

Ray Chemicals Pvt. Ltd

41, KHB Industrial Area, Yelahanka, Bangalore, 560106

India

5

Claforan

GC-244-16

23/3/2021

Công ty Roussel Việt Nam

Claforan 1G Bulk INJ. (Viet.)(ZFF) (Sodium cefotaxim)

NSX

Zentiva Saglik Urunleri Sanayi ve, Ticaret A.S

Kucukkaristiran Mahallesi, Merker Sokak, No: 223/A 39780 Buyukkaristiran, Luleburgaz - Turkey

Turkey

6

Coltramyl 4mg

VD-22638-15

26/5/2020

Công ty Roussel Việt Nam

Thiocolchicoside

NSX

Sanofi Chimie

63480 Vertolaye

France

7

Idarac

VD-22313-15

09/2/2020

Công ty Roussel Việt Nam

Floctafenine

NSX

Sanofi Chime

63480 Vertolaye

France

8

Idarac

VD-22313-15

09/2/2020

Công ty Roussel Việt Nam

Floctafenine

NSX

Sanofi India Limited

3501, 3503-15, 6310B-14, GIDC Estate, post Box No. 136, Ankleshwar 393002, Dist. Bharuch, India

India

9

Moriamin Forte

VD-23274-15

09/9/2020

Công ty Roussel Việt Nam

Moriamin Forte Granules (L-Leucin, L-Isoleucin, Lycine, L-Phenylamin, L-Threonin, L-Valin, L-Tryptophan, L-Methionin, 5-hydroxyanthranilic acid hydroclorid, ascorbic acid, retinol palmitat, ergocalciferol, nicotinamid, pyridoxin hydroclorid, riboflavin, thiamin nitrat, tocopherol acetat, calci pantothenat, cyanocobalamin, folic acid)

NSX

Shenzhen Wanhe Pharmaceutical Co., Ltd

Block C & D, Wanhe Technology complex, 7 Huitong Road, Guangming New District, Shenzhen, China

China

10

Myotalvic 50

VD-20355-13

27/12/2018

Công ty Roussel Việt Nam

Tolperisone hydrochloride

JP XV

Jinan Jinda Pharmaceutical Chemistry Co., Ltd

Zhangqiu Mingshui, Jinan, Shandong, China. No: 250200

China

11

Neutracet 800

VD-25941-16

15/11/2021

Công ty Roussel Việt Nam

Piracetam

DĐVN IV/ EP 8

Jiangxi Yuehua Pharmaceutical Co., Ltd

No 58, ChangxiRoad, Jingdezhen City, Jiangxi Province

China

12

Rocamux

VD-19166-13

6/19/2018

Công ty Roussel Việt Nam

Carbocisteine

BP2011/ EP

Pharmazell Private Limited

Plot No. B5/B6, A1/A2, MEPZ, Tambaran, Chennai-600 045

India

13

Roustadin

VD-26490-17

06/2/2022

Công ty Roussel Việt Nam

Loratadine

USP34

Vasudha pharma Chem Limited

78/A, Vengal Rao Nagar, Hyderabad - 38 Andhra Pradesh

India

14

Rulid

VD-22315-15

2/9/2020

Công ty Roussel Việt Nam

Roxithromycin

NSX

Sanofi Chimie

63480 Vertolaye

France

15

Safena

VD-21984-14

08/12/2019

Công ty Roussel Việt Nam

Atorvastatin Calcium

USP 34

Ind-Swift Laboratories Limited

Phase-1, Industrial Growth Centre (SIDCO), Samba (J&K)

India

16

Sinuflex

VD-23912-15

17/12/2020

Công ty Roussel Việt Nam

Phenylephrin HCl

USP 34

BASF Pharma Chemikalien GmbH & Co. KG

32419 Minden

Germany

17

Sinuflex

VD-23912-15

17/12/2020

Công ty Roussel Việt Nam

Chlorpheniramin maleate

BP2014

Supriya Lifescience Ltd

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

India

18

Sinuflex P

VD-25942-16

15/11/2021

Công ty Roussel Việt Nam

Phenylephrin HCL

BP 2013

BASF Pharma Chemikalien GmbH & Co. KG

32419 Minden

Germany

19

Sinuflex P

VD-25942-16

15/11/2021

Công ty Roussel Việt Nam

Chlorpheniramin maleate

DĐVNIV/ BP 2012

Supriya Lifescience Ltd

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

India

20

Repamax Extra

VD-9785-09

Gia hạn 01/08/2018

Công ty Roussel Việt Nam

Caffeine

DĐVN IV/ EP/ USP

BASF Pharma Chemikalien GmbH & CO. KG

32419 Minden

Germany

21

Nutrigan

VD-11324-10

Gia hạn 01/08/2018

Công ty Roussel Việt Nam

Silymarin

USP 34

Panjin Tianyuan Pharmaceutical Co., Ltd.

Gaosheng Town, Panjing City, Liaoning

China

22

Enassel

VD-17216-12

Gia hạn 01/08/2018

Công ty Roussel Việt Nam

Enaplaril maleate

DĐVN IV/ USP37

Zhejiang Changming Pharmaceutical Co., Ltd, China.

No. 1 Badu Road, Tiantai Industrial Park, Zhejiang

China

23

Rusartin

VD-11322-10

Gia hạn 01/08/2018

Công ty Roussel Việt Nam

Valsartan

USP36

Hetero Labs Ltd

Survey No. 10, I.D.A, Gaddapotharam, Jinnaram Mandal, Medak Dist, Andhra Pradesh

India

24

Metsocort 16

VD-22639-15

26/5/2020

Công ty Roussel Việt Nam

Methylprednisolon

USP37/EP 5

Tianjin Tianyao Pharmaceutical Co., Ltd

19, Xinye 9th Street, West Area of Tianjin Economic- Technological Development Area, Tianjin, 300462

China

25

Metsocort 4

VD-22640-15

26/5/2020

Công ty Roussel Việt Nam

Methylprednisolon

USP37/EP 5

Tianjin Tianyao Pharmaceutical Co., Ltd

19, Xinye 9th Street, West Area of Tianjin Economic- Technological Development Area, Tianjin, 300462

China

26

Omesel 20

VD-23910-15

17/12/2020

Công ty Roussel Việt Nam

Omeprazole pellets 8,5%

NSX

Smilax Laboratories Limited

Plot No. 12/A, Unit-1 Phase-Ill, IDA, Jeedimetla, Hyderabad, Telangana 500055,

India

27

Rocetaf

VD-23911-15

17/12/2020

Công ty Roussel Việt Nam

Paracetamol

USP 34

Anqiu Lu’an Pharmaceutical Ltd

No. 53, Weixu North Road, Anqiu City Shangdong Province, 262100 China

China

28

Rocetaf

VD-23911-15

17/12/2020

Công ty Roussel Việt Nam

Loratadine

USP34

Vasudha pharma Chem Limited

Unit -II, Plot No. 79, Jawaharlal Nehru Pharma City, Thanam Village, Parawada (M) Visakhapatnam District Andhra Pradesh, India

India

29

Rocetaf

VD-23911-15

17/12/2020

Công ty Roussel Việt Nam

Dextromethorphan HBr

BP2013

Wockhardt Limited

Plot No 138 GIDC Estate, Ankleshwar 393002 Dist Bharuchm Gujarat

India

30

Skin Z

VD-22641-15

26/5/2020

Công ty Roussel Việt Nam

Clotrimazole

DĐVN IV/ BP2015

Jintan Zhongxing Pharmaceutical and Chemical Co., Ltd

12# HouYang Chemical Park, Jincheng towns, Jintan, Jiangsu

China

31

Skin Z

VD-22641-15

26/5/2020

Công ty Roussel Việt Nam

Gentamicin sulfate sterile

DĐVN IV/ BP 2012

Yantai Justawarwe Pharmaceutical Co., Ltd

No. 1 Yanfu Road, Zhifu District, Yantai, Shadong Province, P.R

China

32

Skin Z

VD-22641-15

26/5/2020

Công ty Roussel Việt Nam

Betamethasone dipropionate

DĐVN IV/ EP

Newchem S.P.A

Via Roveggia, 47-37136 Verona

Italy

33

Lifextend

VD-22314-15

09/2/2020

Công ty Roussel Việt Nam

Clopidogrel Bisulfate

USP 34

Aurobindo Pharma Ltd

Unit VIII: Sy No. 10 & 13, Gaddapotharam (V), Jinnaram (M), Medak District. A.P

India

Danh Mục này có 33 Khoản./.