Công văn 4532/QLD-ĐK năm 2019 công bố danh mục nguyên liệu để sản xuất thuốc theo hồ sơ đăng ký thuốc đã có giấy đăng ký lưu hành tại Việt Nam đợt 164 do Cục Quản lý Dược ban hành

BỘ Y TẾ
CỤC QUẢN LÝ DƯỢC
-------

CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập - Tự do - Hạnh phúc
---------------

Số: 4532/QLD-ĐK
V/v công bố danh mục nguyên liệu để sản xuất thuốc theo hồ sơ đăng ký thuốc đã có giấy ĐKLH tại Việt Nam đợt 164

Hà Nội, ngày 01 tháng 4 năm 2019

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

TUQ. CỤC TRƯỞNG
TRƯỞNG PHÒNG ĐĂNG KÝ THUỐC




Nguyễn Huy Hùng

STT

Số giấy đăng ký lưu hành thuốc

Hiệu lực giấy đăng ký lưu hành thuốc

Tên nguyên liệu làm thuốc được công bố

Tiêu chuẩn chất lượng của nguyên liệu

Tên cơ sở sản xuất nguyên liệu

Tên nước sản xuất nguyên liệu

1

QLĐB-747-19

27/02/2022

Tenofovir disoproxil fumarate

TC NSX

Acebright (India) Pharma Pvt Ltd.

India

2

QLĐB-747-19

27/02/2022

Lamivudine

USP 40

Shanghai Desano Chemical Pharmaceutical Co., Ltd.

China

3

QLĐB-747-19

27/02/2022

Efavirenz

USP 40

Shanghai Desano Chemical Pharmaceutical Co., Ltd.

China

4

QLĐB-760-19

27/02/2022

Levonorgestrel

EP 7.8

Bayer AG

Germany

5

QLĐB-761-19

27/02/2022

Levonorgestrel

EP 7.8

Bayer AG

Germany

6

VD-31460-19

27/02/2024

Flunarizin dihydroclorid

EP 8.0

Zhengzhou ruikang pharmaceutical co., ltd.

China

7

VD-31461-19

27/02/2024

Spiramycin

BP 2014

Wuxi fortune pharmaceutical co., ltd.

China

8

VD-31461-19

27/02/2024

Spiramycin

EP.8

Topfond Pharmaceutical Co., Ltd

China

9

VD-31462-19

27/02/2024

Loratadin

USP 40 + TC NSX

MOREPEN LABORATORIES LIMITED

India

10

VD-31463-19

27/02/2024

Alphachymotrypsin

USP 40

Beijing Geyuantianrun Bio-tech Co., Ltd.

China

11

VD-31464-19

27/02/2024

Alphachymotrypsin

USP 40

Beijing Geyuantianrun Bio-tech Co., Ltd.

China

12

VD-31465-19

27/02/2024

Irbesartan

USP 40 + TC NSX

ZHEJIANG HUAHAI PHARMACEUTICAL Ltd. China

China

13

VD-31465-19

27/02/2024

Hydroclorothiazid

USP 40 + TC NSX

Suzhou Lixin Pharmaceutical Co., Ltd

China

14

VD-31466-19

27/02/2024

Irbesartan

USP 40 + TC NSX

ZHEJIANG HUAHAI PHARMACEUTICAL Ltd. China

China

15

VD-31466-19

27/02/2024

Hydrociorothiazid

USP 40 + TC NSX

Suzhou Lixin Pharmaceutical Co., Ltd

China

16

VD-31467-19

27/02/2024

Celecoxib

USP 40 + TC NSX

Aarti Drugs Limited

India

17

VD-31468-19

27/02/2024

Flurbiprofen

EP 8.0 + TC NSX

FDC Limited

India

18

VD-31469-19

27/02/2024

Flurbiprofen

EP 8.0 + TC NSX

FDC Limited

India

19

VD-31470-19

27/02/2024

Itraconazol (dưới dạng vi hạt 22%)

TC NSX

LEE PHARMA LIMITED

India

20

VD-31474-19

27/02/2024

Acetylcystein

USP 38

WUHAN GRAND HOYO CO., LTD

China

21

VD-31475-19

27/02/2024

Acetylcystein

USP 38

WUHAN GRAND HOYO CO., LTD

China

22

VD-31476-19

27/02/2024

Nabumeton

USP 38

DIVI’S LABORATORIES LIMITED

India

23

VD-31477-19

27/02/2024

Clobetasol propionat

USP 40

A VIK PHARMACEUTICAL LTD

India

24

VD-31478-19

27/02/2024

Valsartan

USP 40 + TC NSX

IPCA LABORATORIES LIMITED

India

25

VD-31479-19

27/02/2024

Esomeprazol magnesi trihydrat

USP 40

EVEREST ORGANICS LIMITED

India

26

VD-31480-19

27/02/2024

Esomeprazol magnesi trihydrat

USP 40

EVEREST ORGANICS LIMITED

India

27

VD-31481-19

27/02/2024

Betamethason valerat

USP 39

A VIK PHARMACEUTICAL LTD

India

28

VD-31481-19

27/02/2024

Neomycin sulfat

EP 8.0

Sichuan Long March Pharmaceutical Co., Ltd

China

29

VD-31482-19

27/02/2024

Clotrimazol

USP 40

CHANGZHOU YABANG PHARMACEUTICAL CO., LTD

China

30

VD-31483-19

27/02/2024

Etoricoxib

TC NSX

KEKULE PHARMA LIMITED

India

31

VD-31484-19

27/02/2024

Fluconazol

EP 8.0

GRANULES INDIA LIMITED

India

32

VD-31485-19

27/02/2024

Fluconazol

EP 8.0

GRANULES INDIA LIMITED

India

33

VD-31486-19

27/02/2024

Fluconazol

EP 8.0

GRANULES INDIA LIMITED

India

34

VD-31487-19

27/02/2024

Acid fusidic hemihydrat

EP 8.0

JOYANG LABORATORIES

China

35

VD-31488-19

27/02/2024

Acid fusidic hemihydrat

EP 8.0

JOYANG LABORATORIES

China

36

VD-31488-19

27/02/2024

Betamethason valerat

USP 39

A VIK PHARMACEUTICAL LTD

India

37

VD-31489-19

27/02/2024

Gabapentin

USP 40 + TC NSX

ZHEJIANG CHIRAL MEDICINE CHEMICALS

China

38

VD-31490-19

27/02/2024

Desloratadin

EP8.0 + TC NSX

MOREPEN LABORATORIES LIMITED

India

39

VD-31491-19

27/02/2024

Pregabalin

EP 9.0 + TC NSX

Maps LABORATORIES PRIVATE LIMITED

India

40

VD-31492-19

27/02/2024

Pregabalin

EP 9.0 + TC NSX

Maps LABORATORIES PRIVATE LIMITED

India

41

VD-31493-19

27/02/2024

Pregabalin

EP 9.0 + TC NSX

Maps LABORATORIES PRIVATE LIMITED

India

42

VD-31494-19

27/02/2024

Pyridoxin hydroclorid

TC NSX

DSM Nutritional Products GmbH

Switzerlan

43

VD-31496-19

27/02/2024

Aciclovir

USP 38

Zhejiang Zhebei Pharmaceutical Co., Ltd

China

44

VD-31497-19

27/02/2024

Aciclovir

USP 40

Zhejiang Zhebei Pharmaceutical Co., Ltd

China

45

VD-31498-19

27/02/2024

Zinc gluconat

USP 40

GIVAUDAN- LAVIROTTE

France

46

VD-31499-19

27/02/2024

Calcium lactat pentahydrat

USP 40

GLOBAL CALCIUM Pvt. Ltd

India

47

VD-31500-19

27/02/2024

Paracetamol

USP 41

ANQIU LU’AN PHARMACEUTICAL CO. LTD

China

48

VD-31501-19

27/02/2024

Paracetamol

USP 39 + TC NSX

ANQIU LU’AN PHARMACEUTICAL CO. LTD

China

49

VD-31502-19

27/02/2024

Povidon iod

USP 38

R.N.LABORATORIES PVT. LTD

India

50

VD-31503-19

27/02/2024

Prednisolon sodium phosphat

USP 40 + TC NSX

HENAN LIHUA PHARMACEUTICAL CO., LT.

China

51

VD-31507-19

27/02/2024

Pantoprazol sodium sesquihydrat

EP 8.0 + TC NSX

DONG WHA PHARM CO., LTD

Korea

52

VD-31508-19

27/02/2024

Dexamethasone sodium phosphate

BP 2016

Zhejiang Xianju Pharmaceutical Co., Ltd

China

53

VD-31525-19

27/02/2024

Povidon iodin

USP 38

Adani Pharmachem

India

54

VD-31526-19

27/02/2024

Acid folic

BP 2016

DSM Nutritional Products Ltd

Singapore

55

VD-31527-19

27/02/2024

Paracetamol

USP 38

Mallinckrodt Inc

USA

56

VD-31528-19

27/02/2024

Clorphemramm maleat

BP 2015

Supriya lifescience Ltd

India

57

VD-31529-19

27/02/2024

Clotrimazol

USP 36

Changzhou Yabang Pharmaceutical Co., Ltd

China

58

VD-31530-19

27/02/2024

Methylprednisolon

USP 40

Zhejiang xianju pharmaceutical co. Ltd

China

59

VD-31531-19

27/02/2024

Acetylcystein

USP 39/EP 9

Fabbrica Italians Sintetici S.P.A.

Italy

60

VD-31532-19

27/02/2024

Sulfamethoxazol

BP 2013

Virchow Laboratories Limited

India

61

VD-31532-19

27/02/2024

Trimethoprim

BP 2013

Shouguang Fukang Pharmaceutical Co., Ltd.

China

62

VD-31533-19

27/02/2024

Ibuprofen

USP 38

Basf corporation

Germany

63

VD-31534-19

27/02/2024

Paracetamol

BP 20146

Hebei jiheng (group) pharmaceutical co. ltd

China

64

VD-31535-19

27/02/2024

Pyridoxin hydroclorid

USP 37

Jiangxi Tianxin Pharmaceutical co.,ltd

China

65

VD-31535-19

27/02/2024

Thiamin mononitrat

USP 37

Jiangxi Tianxin Pharmaceutical co.,ltd

China

66

VD-31535-19

27/02/2024

Cyanocobalamin

USP 37

Ningxia Kingvit Pharmaceutical co., ltd.

China

67

VD-31847-19

27/02/2024

Clopidogrel bisulfate

USP 40

IND-SWIFT LABORATORIES LIMITED

India

68

VD-31848-19

27/02/2024

Fexofenadine hydrochloride

USP 40

Vasudha Pharma Chem Limited

India

69

VD-31849-19

27/02/2024

Chymotrypsin

USP 40

BEIJING GEYUANTIANRUN BIO-TECH CO., LTD.

China

70

VD-31850-19

27/02/2024

Paracetamol

EP 9.0

MALLINCKRODT INC

USA

71

VD-31851-19

27/02/2024

Irbesartan

USP 41

CTX LIFESCIENCES (P) LTD

India

72

VD-31852-19

27/02/2024

Montelukast sodium

USP 40

MOREPEN LABORATORIES LIMITED

India

73

VD-31853-19

27/02/2024

Loperamide hydrochloride

BP 2015

VASUDHA PHARMA CHEM LTD

India

74

VD-32100-19

27/02/2024

Acid Benzoic

EP 7

Emerald Performance Materials (kalama chemical)

Netherlands

75

VD-32100-19

27/02/2024

Acid Salicylic

USP 38

Novacyl

France

76

VD-32100-19

27/02/2024

Iod

USP 38

G.amphray laboratories

India

77

VD-32103-19

27/02/2024

Aspirin

USP 37

JQC (HUAYIN) PHARMACEUTICAL CO., LTD

China

78

VD-32103-19

27/02/2024

Natri salicylat

USP 38

Yixing City Shenguang Mecicine Chemical co., Ltd

China

79

VD-32104-19

27/02/2024

Hydrogen peroxyd (50%)

TCCS

Huchems Fine Chemical Corp

Korea

80

VD-32106-19

27/02/2024

Xanh methylen

USP 38

Vanshi Chemicals Pvt Ltd

India

81

VD-32111-19

27/02/2024

N-Acetylcysteine

EP 9.0

MOEHS CATALANA, S.L.

SPAIN

82

VD-32112-19

27/02/2024

Calcium Lactate Pentahydrate

EP 8.0

Purac Biochem

Nederland

83

VD-32113-19

27/02/2024

Fosfomycin Calcium hydrat

EP 9.0

Northeast Pharmaceutical Group Co., Ltd

China

84

VD-32114-19

27/02/2024

Dequalinium

EP 9.0

LEBSA

Spain

85

VD-32115-19

27/02/2024

Methylergometrine maleate

USP 40

Teva Czech Industries S.r.o.

Czech

86

VD-32116-19

27/02/2024

Cilostazol

USP 40

AMSAL CHEM PVT. LTD.

India

87

VD-32127-19

27/02/2024

Aciclovir

USP 38

Zhejiang Charioteer Pharmaceutical Co., Ltd.

China

88

VD-32128-19

27/02/2024

Azithromycin dihydrate

USP 39

Shanghai Shyndec Pharmaceutical (Haimen) Co., Ltd.

China

89

VD-32129-19

27/02/2024

Berberine chloride

JP XVII

Northeast Pharmaceutical Group Co., Ltd.

China

90

VD-32130-19

27/02/2024

Cephalexin monohydrate

BP 2014

Lupin Limited

India

91

VD-32131-19

27/02/2024

Cimetidine

USP 36

Jiangsu Baosheng Longcheng Pharmaceutical Co., Ltd.

China

92

VD-32132-19

27/02/2024

Cloxacillin Sodium

USP 38

Rajasthan Antibiotics Limited

India

93

VD-32133-19

27/02/2024

Dexamethasone acetate

EP 7.0

Zhejiang Xianju Pharmaceutical Co., Ltd

China

94

VD-32134-19

27/02/2024

Doxycy cline hyclate

EP 8.0

Kunshan Chemical & Pharmaceutical Co., Ltd

China

95

VD-32135-19

27/02/2024

Erythromycin stearate

BP 2013

SM Biomed SDN. BHD.

Malaysia

96

VD-32136-19

27/02/2024

Erythromycin stearate

BP 2014

SM Biomed SDN. BHD.

Malaysia

97

VD-32137-19

27/02/2024

Ethambutol hydrochloride

BP 2013

Linaria Chemicals (Thailand) Ltd.

Thailand

98

VD-32138-19

27/02/2024

Ibuprofen

BP 2013

Strides Shasun Limited

India

99

VD-32139-19

27/02/2024

Fenofibrate (non- micronized)

EP 7.0

Zhejiang Excel Pharmaceutical Co., Ltd

China

100

VD-32140-19

27/02/2024

Atorvastatin calcium

USP 38

Cadila Healthcare Ltd.

India

101

VD-32141-19

27/02/2024

Dried Aluminum Hydroxide Gel

USP 35

SPI Pharma

USA

102

VD-32142-19

27/02/2024

Mannitol

EP 8.0

Roquette Freres

France

103

VD-32143-19

27/02/2024

Isoniazid

USP 40

Vista Organics (P) Ltc.

India

104

VD-32144-19

27/02/2024

Betamethasone

EP 7.0

Zhejiang Xianju Pharmaceutical Co., Ltd.

China

105

VD-32145-19

27/02/2024

Indomethacin

EP 8.0

Taicang Pharmaceutical Factory

China

106

VD-32146-19

27/02/2024

Betamethasone

EP 8.0

Zhejiang Xianju Pharmaceutical Co., Ltd

China

107

VD-32146-19

27/02/2024

Dexchlorphenirami ne maleate

BP 2013

Supriya Lifescience Ltd.

India

108

VD-32147-19

27/02/2024

Albendazole

USP 38

Ka Malle Pharmaceuticals Ltd

India

109

VD-32150-19

27/02/2024

Olanzapine

USP 38

Cadila Pharmaceuticals Limited

India

110

VD-32151-19

27/02/2024

Povidone Iodine

USP 36

BASF Corporation

United

111

VD-32152-19

27/02/2024

Dextromethorphan Hydrobromide

USP 36

Wockhardt Limited

India

112

VD-32154-19

27/02/2024

Tetracycline Hydrochloride

BP 2016

NINGXIA QIYUAN Pharmaceutical Co., Ltd.

China

113

VD-32155-19

27/02/2024

Thiamine mononitrate (Vitamin B1)

BP 2014

Huazhong Pharmaceutical Co., Ltd

China

114

VD-32155-19

27/02/2024

Pyridoxine hydrochloride (Vitamin B6)

BP 2014

Jiangxi Tianxin Pharmaceutical Co., Ltd.

China

115

VD-32155-19

27/02/2024

Cyanocobalamin (Vitamin B12)

USP 38

Ningxia Kingvit Pharmaceutical Co., Ltd.

China

116

VD-32156-19

27/02/2024

Vitamin B1 (Thiamine mononitrate)

BP 2015

Jiangxi Tianxin Pharmaceutical Co., Ltd.

China

117

VD-32191-19

27/02/2024

Alpha chymotrypsin

USP 39

Faizyme Laboratories (Pty) Ltd

South Africa

118

VD-32192-19

27/02/2024

Glucosamine sulphate sodium chloride

USP 39

Andhra Medi Pharma India Pvt Ltd

India

119

VD-32192-19

27/02/2024

Chondroitin sulfate sodium

USP 39

Jiaxing Hengjie Biopharmaceutical Co., Ltd.

China

120

VD-32193-19

27/02/2024

Galantamine hydrobromide

EP 8.0

Indena S.p.A.

Italy

121

VD-32194-19

27/02/2024

Lincomycin HCl

Ph. Eur 7.3

Nanyang Pukang Pharmaceutical Co., Ltd.

China

122

VD-32195-19

27/02/2024

Allopurinol

Ph. Eur. 8.0

Harman Finochem Ltd

India

123

VD-32196-19

27/02/2024

Meloxicam

Ph. Eur. 8.0

AMSA - Anonima Materie Sintetiche & Affini S.P.A.

Italy

124

VD-32197-19

27/02/2024

Meloxicam

Ph. Eur. 8.0

AMSA - Anonima Materie Sintetiche & Affini S.P.A.

Italy

125

VD-32198-19

27/02/2024

Montelukast sodium

USP 38

Laurus Labs Private Limited

India

126

VD-32199-19

27/02/2024

Nebivolol hydrochloride

Nhà sản xuất

MSN Pharmachem Private Limited.

India

127

VD-32200-19

27/02/2024

Piracetam

EP 8.0

Jiangxi Yuehua Pharmaceutical Co., Ltd.

China

128

VD-32201-19

27/02/2024

Sulbutiamine

Nhà sản xuất

Luoyang Chemman Pharmchem CO. LTD.

China

129

VD-32202-19

27/02/2024

Tenofovir disoproxil fumarate

Nhà sản xuất

Mangalam Drugs and Organics Ltd.

India

130

VD-32202-19

27/02/2024

Emtricitabine

Nhà sản xuất

Hetero Labs Limited

India

131

VD-32289-19

27/02/2024

Mosaprid cittat dihydrat

JP XVII

DAEHE Biopharma

Korea

132

VD-32349-19

27/02/2024

Sodium Chloride

EP 9

Dominion Salt Limited

New Zealand

133

VD-32349-19

27/02/2024

Sodium Chloride

EP 9

Esco - European Salt company GmbH & Co. KG

Germany

134

VD-32398-19

27/02/2024

Bambuterol hydrochloride

BP 2018

Aarti Industries Limited

India

135

VD-32399-19

27/02/2024

Bisoprolol fumarate

EP 9.0

Moehs Catalana, S.L.

Spain

136

VD-32400-19

27/02/2024

Magnesium gluconate

USP 38

Givaudan-Lavirotte

France

137

VD-32400-19

27/02/2024

Calcium glycerophosphate (50% Liquid Calcium

In-house

Givaudan-Lavirotte

France

138

VD-32401-19

27/02/2024

Fluconazole

EP 8.0

Glenmark Pharmaceuticals Limited

India

139

VD-32402-19

27/02/2024

Lamivudine

USP 39

Hetero Labs Limited (Unit-IX)

India