Công văn 3654/QLD-ĐK năm 2018 bổ sung Danh mục nguyên liệu làm thuốc NK không phải cấp phép

Thuốc thành phẩm

Nguyên liệu hoạt chất

STT

Tên thuốc

Số giấy đăng ký lưu hành thuốc

Ngày hết hiệu lực của giấy đăng ký lưuhành

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

BECOLIZYN

VD-5297-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B1 (Thiamine Mononitrate)

BP 2015

Jiangxi Tianxin Pharmaceutical Co.,Ltd

Le’anjiang Industrial Zone, Leping, Jiangxi 333300, China

China

2

BECOLIZYN

VD-5297-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B2 (Riboflavin)

USP 39

Chifeng Pharmaceutical Co., Ltd

84 Yidong Street, Hongshan District, Chifeng, Inner Mongotia 024001 China

China

3

BECOLIZYN

VD-5297-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B6 (Pyridoxine Hydrochloride)

BP 2015

Jiangxi Tianxin Pharmaceutical Co.,Ltd

Le’anjiang Industrial Zone, Leping, Jiangxi 333300, China

China

4

BECOLIZYN

VD-5297-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin PP (Niacinamide)

USP 39

Tianjin Zhongrui Pharmaceutical Co., Ltd.

Chengguan Town, Wuqing District, Tianjin, China

China

5

BECOLIZYN

VD-5297-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Acid folic (Folic acid)

USP 37

Changzhou Kangrui Chemical Co., Ltd

Baizhang town, Xinbei district, Changzhou, Jiangsu, China

China

6

DASAVIT B12

VD-6595-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B1 (Thiamine Mononitrate)

BP 2015

Huazhong Pharmaceutical Co.,Ltd-China

No.71 West Chunyuan Road, Xiangfan, Hubei, China

China

7

DASAVIT B12

VD-6595-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B6 (Pyridoxine Hydrochloride)

BP 2015

DSM Nutritional Products GmbH

Emil-Barell-Str.3 79639 Grenzach - Wyhlen, Germany

China

8

DASAVIT B12

VD-6595-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B12 (Cyanocobalamin)

EP 9

North China Pharmaceutical Victor Co.,Ltd, China

No.9 Zhaiying North Street, Shijiazhuang, China

Germany

9

DASAVIT B12

VD-6595-08

14/03/2018

Công ty TNHH dược phẩm USA- NIC

Acid folic (Folic Acid)

USP 37

Shandongxinfa Pharmaceutical Co., Ltd, China

No.1 Tongxing Road, Kenli Country Dongying, China

China

10

LOPEGORIC

VD-17265-12

07/06/2018

Công ty TNHH dược phẩm USA- NIC

(Loperamide Hydrochloride)

USP 36

Fleming Laboratories Limited

4th Floor, Madhupala Towers, Ameerpet, Hyderabad-500034, Telangana, India

India

11

PHAANEDOL

VD-17273-12

07/06/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Hebei Jiheng (Group) Pharmaceutical Co.,Ltd

No.368 Jianshe Street, Hengshui City, Hebei Province, 053000, P.R.China

China

12

PIRAXNIC

VD-17274-12

07/06/2018

Công ty TNHH dược phẩm USA- NIC

Piracetam

EP 8

Jiangxi Yuehua Pharmaceutical Co., Ltd

No 5 8, ChangxiRoad, Jingdezhen City, China

China

13

PIRAXNIC

VD-17274-12

07/06/2018

Công ty TNHH dược phẩm USA- NIC

Cinnarizin (Cinnarizine)

EP 8

Ray Chemicals PVT.Ltd

41, K.H.B. Industrial Area Yalahanka Bengaluru -560 108 India

India

14

THEGALIN (CPP)

VD-17276-12

07/06/2018

Công ty TNHH dược phẩm USA- NIC

Alimemazin tartrat (Alimemazine tartrate)

BP 2014

SOMET

5, Rue de I’ndustrie- MC 98000 Monaco

Monaco

15

ANRODIN

VD-17255-12

19/07/2018

Công ty TNHH dược phẩm USA- NIC

Natri benzoat (Sodium Benzoate)

BP 2016

Hugestone Enterprise Co., Ltd

9/F, Fortune bulling, No, 359 Hongwu Road, Nanjing 210002, China

China

16

FLUE - COLDCAP

VD-17262-12

19/07/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Anqiu Lu’an Pharmaceutical Co.,Ltd

No.35.Weixu North Road, Anqiu, Shandong, China

China

17

FLUE- COLDCAP

VD-17262-12

19/07/2018

Công ty TNHH dược phẩm USA- NIC

Clorpheniramin maleat (Chlorpheniramine Maleate)

USP 38

Supriya Lifescience Ltd

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

India

18

ERYTHROMYCIN 500mg

VD-17260-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Erythromycin

USP 39

Zhejiang Guobang Pharmaceutical CO., LTD

No.6, Wei Wu Road, HangZhou Gulf Shang Yu Industrial Zone, Zhejiang, P.R.China (312369)

China

19

MEDIALECZAN

VD-17266-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Anqiu Lu’an Pharmaceutical Co.,Ltd

No.35. Weixu North Road, Anqiu, Shandong, China

China

20

MEDIALECZAN

VD-17266-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Ibuprofen

BP 2016

Iol Chemicals And Pharmaceutical- India

Trident Complex, Raikot Road, Barnala- 148 101 (Pb.) India

India

21

NICBAZAGIN (CPP)

VD-17269-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Anqiu Lu’an Pharmaceutical Co.,Ltd

No.35. Weixu North Road, Anqiu, Shandong, China.

China

22

NICBAZAGIN (CPP)

VD-17269-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Cafein (Caffeine Anhydrous)

EP 9/ USP 40

Aarti Industries Limited

Unit-V, L-28/29, MIDC Area, Tarapur, Tal.Palghar, Dist. Thane-401506, Maharashtra, India.

India

23

VOLGASRENE 75

VD-17277-12

01/08/2018

Công ty TNHH dược phẩm USA- NIC

Diclofenac natri (Diclofenac Sodium (bromine free))

BP 2015

Henan Dongtai Pharmaceutical Co., Ltd

East Changhong Road, Tangyin, Henan, China

China

24

CALCIUM - NIC Extra

VD-16165-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Calci glucoheptonat (Calcium glucoheptonate)

USP 37

Givaudan-Lavirotte - Pháp

56 Rue Paul Cazeneuve 69008 Lyon -France

France

25

CALCIUM - NIC Extra

VD-16165-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Calci Gluconat

USP 35

Zhejiang Tianyi Food Additives Co., Ltd

Room 1903, Building 2, Lujiazui, Century Finance Square, No. 759 South Yanggao Road, Pudong, Shanghai, China 200127

China

26

CALCIUM - NIC Extra

VD-16I65-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin C (Ascorbic acid)

BP 2014

Hebei Welcome Pharmaceutical Co., Ltd

No.11, Zhaiying North Street, Shijiazhuang, China Post code (050031) China

China

27

CALCIUM- NIC Extra

VD-16165-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin PP (Nicotinamide)

USP 37

Brother Enterprises Holding Co.,Ltd

Zhouwangmiao Industrial Zone, Haining City, Zhejiang Province, China

China

28

TUXSINAL SYRUP

VD-15615-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Dextromethorphan Hydrobromide

USP 39

Wockhardt- India

138, Gidc Estate, Ankleshwar-393002, Dist Bharuch, Gujarat, India

India

29

TUXSINAL SYRUP

VD-15615-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Chlorpheniramine Maleate

USP 38

Mahrshee Laboratories Pvt. Ltd.

Plot 3014-15, G.I.D.C Indl, Area, Phase-III, Panoli 394116, India

India

30

TUXSINAL SYRUP

VD-15615-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Natri benzoat (Sodium Benzoate powder Food grade)

BP 2000

Hugestone Enterprise Co., Ltd

9/F, Fortune Building, No.359 Hongwu Road, Nanjing 210002, China

China

31

TUXSINAL SYRUP

VD-15615-11

12/12/2018

Công ty TNHH dược phẩm USA- NIC

Guaifenesin

USP 39

Pan drugs limited

167-168 Gidc Nandesari Industrial Estate, Vadodara, Gujarat 391340, India

India

32

ACINMUXI

VD-17254-12

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Acetylcystein (N-Acetyl-L- Cysteine)

USP 36

Wuhan Grand Hoyo Co., Ltd

No. 1 Industrial Park, Gedian Economy Devolop Zone, E’Zhou City, Hubei, China

China

33

AZITNIC

VD-12664-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Azithromycin (Azithromycin dihydrate)

USP 39

Zhejiang Guobang Pharmaceutical Co., Ltd

6, Wei Wu Road, Hangzhou Gulf ShangYu Industrial Zone, Zhejiang, P.R.China (312369)

China

34

AZITNIC 500

VD-12665-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Azithromycin dihydrate

USP 39

Zhejiang Guobang Pharmaceutical Co., Ltd

6, Wei Wu Road, Hangzhou Gulf ShangYu Industrial Zone, Zhejiang, P.R.China (312369)

China

35

COLDNIC

VD-14069-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Cetirizine Dihydrochloride

EP 8.0

Supriya Lifescience LTD

207/208, Udyog Bhavan, Sonawala Road, Gcregaon (East), Mumbai 400 063. Maharashtra, India

India

36

COLDNIC

VD-14069-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Guaifenesin

USP 39

Zhejiang Jianfeng Haizhou Pharmaceutical Co.,Ltd

Yunxi Road 147#, Jiaojiang, Taizhou, Zhejiang, China

China

37

COLDNIC

VD-14069-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dextromethorphan Hydrobromide

USP 39

Divi’s Laboratories Limited

Divi Towers, 1- 72/23(P)/Divis/303, Cyber Hills, Gachibowli, Hyderabad - 500 032. Telangana, India.

India

38

DASATEX EXTRA

VD-14071-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Anqiu Lu’an Pharmaceutical Co.,Ltd

No.35. Weixu North Road, Anqiu, Shandong, China.

China

39

DASATEX EXTRA

VD-14071-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Diclofenac Sodium

BP 2015

Suzhou Ausun Chemical Co.,Ltd

No.6, Jinshan Road, Hi-Tech Industrial Development Zone, Suzhou, Hangsu, China

China

40

DOGRACIL

VD-14074-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Sulpirid (Sulpiride)

EP 9

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd

No.29 Chengnan Xi Lu, ingpu Qu, Huai’an, Jiangsu 223002, China

China

41

HISTALIFE

VD-14887-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Cyproheptadine Hydrochloride

BP 2016

Vamsi labs ltd

A-14/15, MIDC Area, Chincholi, Solapur-413255, Maharashtra (India)

India

42

DESLOX

VD-12673-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Desloratadin (Desloratadine)

EP 8

Morepen Laboratories Limited

Village Masulkhana, Parwanoo, Distt, Solan, (H.P.) India

India

43

NEO - GOLINON

VD-17268-12

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Natri benzoat (Sodium Benzoate)

BP 2000

Hugestone Enterprise Co., Ltd

9/F, Fortune Building, No.359 Hongwu Road, Nanjing 210002, China

China

44

NEO - GOLINON

VD-17268-12

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dextromethorphan Hydrobromide

USP 39

Wockhardt- India

138, Gidc Estate, Ankleshwar-393002, Dist Bharuch, Gujarat, India

India

45

NIC-VITA SIRO

VD-14079-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

L - Lysine HCl

USP 36

Shijiazhuang Shixing Amino Acid Co., Ltd

Jiacun, Xingan, Gaocheng, Shijiazhuang, 052160, China

China

46

NIC-VITA SIRO

VD-14079-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B1 (Thiamine Mononitrate)

BP 2015

Jiangxi Tianxin Pharmaceutical Co,,Ltd

Le’anjiang Industrial Zone, Leping, Jiangxi 333300, China

China

47

NIC-VITA SIRO

VD-14079-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B6 (Pyridoxin Hydrochloride)

BP 2015

Jiangxi Tianxin Pharmaceutical Co.,Ltd

Le’anjiang Industrial Zone, Leping, Jiangxi 333300, China

China

48

NIC - VITA SIRO

VD-14079-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Vitamin B12 (Cyanocobalamin )

EP 9

Hebei Yuxing Bio- Engineering Co.,Ltd

Xicheng District, Ningjin Country, Hebei Province, China

China

49

NIC BESOLVIN 4

VD-18144-12

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Bromhexin HCI (Bromhexine Hydrochloride)

EP 8

Orex Pharma Pvt.Ltd.Thane (W)

Loan license factory at: N- 31, Additional M.I.D.C, Ambemath, Ambemath- 421506 Taluka: Dombivali City Dist: Dombivali City

India

50

NIC BESOLVIN 8

VD-17794-12

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Bromhexine Hydrochloride

EP 8

Orex Pharma Pvt.Ltd.Thane (W)

Pisal House, Nakhwa Compound, Stadium Road, Nr.CIDCO Bus Std, Thane (W)-400601

India

51

NICSPA

VD-14606-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Alverin citrate (Alverine citrate)

EP 8

Shanghai Holdenchem Co., Ltd

Touzeng Village, Binhuai Town, Binhai Country, Yancheng, Jiangsu Province, China (Zhongshan 3rd Road, Binhai Economic Development Zone, Jiangsu Province)

China

52

PANCRENIC

VD-9135-09

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Pancreatin

USP 37

Sichuan Biosyn Pharmaceutical Co.,Ltd

DuanJiaBa, Xijiao, Deyang City, Sichuan Province, China

China

53

PANCRENIC

VD-9135-09

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Simethicon (Simethicone)

USP 40

RioCare India Pvt.Ltd

No R-940, TTC Industrial Area, MIDC Rabale, Navi Mumbai-400701, Maharashtra, India

India

54

PHAANEDOL cảm cúm

VD-14082-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Hebei Jiheng (Group) Pharmaceutical Co., Ltd

No.368 Jianshe Street, Hengshui City, Hebei Province, 053000, P.R. China

China

55

PHAANEDOL cảm cúm

VD-14082-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Cafein (Caffeine Anhydrous)

BP 2016

Cspc Innovation Pharmaceutical Co., Ltd

No. 36 Fuqiang Western Road, Luancheng Count, Shi Jiazhuang City, Hebei Province, China

China

56

PHAANEDOL cảm cúm

VD-14082-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Phenylephrine Hydrochloride

USP 37

Unichem Laboratories Ltd

197, Sector -1, Pithampur - 454 775, Dist - Dhar (M.P.) India

India

57

POLACANMIN 6

VD-14083-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dexclorpheniramine maleate

USP 37

Nivedita Chemicals Pvt., Ltd

A-14, M.D.I.C. Andheri (East), Mumbai-40093, Maharashtra, India.

India

58

PREDMEX - NIC

VD-12677-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dexamethasone acetate

USP 39

Zhejiang Xianju Pharmaceutical Co.,Ltd

No.1 Xianyao Road, Xianju, Zhejiang, China

China

59

PREDNISOLON - F CAPS

VD-12679-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dexamethasone acetate

BP 2016

Henan Lihua Pharmaceutical Co.,Ltd

Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Henan, China

China

60

PREDNISON

VD-5 682-08

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Prednison (Prednisone)

USP 38

Zhejiang Xianju Pharmaceutical Co., Ltd

No. 1 Xianyao Road, Xianju, Xhejiang, China

China

61

RATAF

VD-15301-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Paracetamol

BP 2016

Hebei Jiheng (Group) Pharmaceutical Co.,Ltd

No.368 Jianshe Street, Hengshui City, Hebei Province, 053000, P.R. China

China

62

RATAF

VD-15301-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Loratadin (Loratadin U.S.P.37 (Micronized))

USP 37

Morepen Laboratories Limited

409, Antriksh Bhawan 22 Kasturba Gandhi Marg, New Delhi -110 001, India

India

63

RATAF

VD-15301-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Dextromethorphan Hydrobromide

USP 39

Divi’s Laboratories Limited

Factory: UNIT-1, Lingojigudem Village, Choutuppal Mandal, Nalgonda District, Telangana - 508252, INDIA

India

64

SIBETINIC CAPS

VD-10843-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Flunarizin hydrochlorid

EP 8

Weihai Disu Pharmaceutical Co.,Ltd

No. 55 Qilu Road, Economic & Technological Development Zone, Weihai, Shandong, China, 264205

China

65

SIBETINIC SOFT

VD-10844-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Flunarizin hydrochlorid

EP8

Weihai Disu Pharmaceutical Co.,Ltd

No.55 Qilu Road, Economic&Technological Development Zone, Weihai, Shandong, China, 264205

China

66

SIMGULINE 10

VD-14889-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Montelukast Sodium

USP 38

Metrochem Api Private Limited

302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad-500038 Telangana, India.

India

67

SOLONIC

VD-10845-10

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Prednisolon (Prenisolone)

BP 2014

Henan Lihua Pharmaceutical Co., Ltd

Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Henan, China

China

68

SOLONIC10mg

VD-14086-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Prednisolon (Prenisolone)

BP 2016

Henan Lihua Pharmaceutical Co.,Ltd

Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Henan, China

China

69

TELGATE 120

VD-14089-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Fexofenadine Hydrochloride

USP 40

Virupaksha Organics Limited

Survey No. 10, Gaddapotharam Village, Jinnaram Mandal, Medak Dist-502319, Telangana, India.

India

70

TERGODE

VD-14092-11

14/12/2018

Công ty TNHH dược phẩm USA- NIC

Guaifenesin

USP 39

Pan Drugs Limited - India

167-168 Gidc Nandesari Industrial Estate, Vadodara, Gujarat 391340, India

India

71

DOGRACIL

VD-18139-12

20/12/2018

Công ty TNHH dược phẩm USA- NIC

Sulpirid (Sulpiride)

EP 9

Jiangsu Tasly Diyi Pharmaceutical Co.,Ltd

No.168 Chaoyang Road, Qingpu Industrial Park, Huaian, 223003, China.

China

72

AZITHROMY CIN 250mg

VD-4193-07

30/12/2018

Công ty TNHH dược phẩm USA- NIC

Azithromycin dihydrate

USP 40

Zhejiang Guobang Pharmaceutical Co., Ltd

6, Wei Wu Road, Hangzhou Gulf ShangYu Industrial Zone, Zhejiang, P.R.China (312369)

China