Công văn 5197/QLD-ĐK 2019 nguyên liệu để sản xuất thuốc không phải cấp phép nhập khẩu

BỘ Y TẾ
CỤC QUẢN LÝ DƯỢC
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Số:5197/QLD-ĐK
V/v: Công bốdanhmục nguyên liệu để sản xuất thuốc theo hồ sơ đăng ký thuốc đã có giấy đăng ký lưu hành tại Việt Nam được nhập khẩu không phải thực hiện cấp phép nhập khẩu - Đợt 164

CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập - Tự do - Hạnh phúc
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Hà Nội, ngày 09 tháng4năm 2019

Nơi nhận:
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- Lưu: VT, ĐKT (QH).

TUQ. CỤC TRƯỞNG
TRƯỞNG PHÒNG ĐĂNG KÝ THUỐC




Nguyễn Huy Hùng

STT

Số giấy đăng ký lưu hành thuốc

Hiệu lực của giấy đăng ký lưu hành

Tên nguyên liệu làm thuốc được công bố

Tiêu chuẩn chấtlượng của nguyên liệu

Tên cơsở sản xuất nguyên liệu

Tên nước sản xuất nguyên liệu

1

VD-31780-19

27/02/2024

Valsartan

USP 36

Smilax Laboratories Limited

India

2

VD-31780-19

27/02/2024

Hydrochlorothiazide

USP 36

CTX Life Sciences Pvt. Ltd

India

3

VD-31783-19

27/02/2024

Ramipril

EP 7.0

Aarti Industries Limited

India

4

VD-31774-19

27/02/2024

Adrenalin bitartrat

USP 38

Medinex Laboratories Pvt. Ltd

India

5

VD-31785-19

27/02/2024

Cyanocobalamin

USP 38

Ningxia Kingvit Pharmaceutical Co., Ltd

China

6

VD-31784-19

27/02/2024

Cyanocobalamin

USP 38

Ningxia Kingvit Pharmaceutical Co., Ltd

China

7

VD-31775-19

27/02/2024

Cephalexin monohydrate

BP 2014

NCPC Hebei Huamin Pharmaceutical Co., Ltd

China

8

VD-31776-19

27/02/2024

Cefuroxime axetil

USP 35

Nectar Lifesciences Ltd

India

9

VD-31778-19

27/02/2024

Amoxicillin trihydrate

BP 2015

DSM Sinochem Pharmaceuticals India Pvt. Ltd

India

10

VD-31778-19

27/02/2024

Potassium Clavulanate With Avicel (1:1)

EP 8.0

Sinopharm Weiqida Pharmaceutical Co., Ltd

China

11

VD-31779-19

27/02/2024

Amoxicillin trihydrate

BP 2015

DSM Sinochem Pharmaceuticals India Pvt. Ltd

India

12

VD-31779-19

27/02/2024

Potassium Clavulanate With Avicel (1:1)

EP 8.0

Sinopharm Weiqida Pharmaceutical Co., Ltd

China

13

QLĐB-744-19

27/02/2022

Tenofovir disoproxil fumarate

NSX

Acebright (India) Pharma Pvt. Ltd.

India

14

QLĐB-744-19

27/02/2022

Lamivudine

USP 40

Shijiazhuang Lonzeal Pharmaceuticals Co., Ltd

China

15

QLĐB-744-19

27/02/2022

Efavirenz

USP 40

Shanghai Desano Chemical Pharmaceutical Co.,Ltd

China

16

VD-31560-19

27/02/2024

Pyridoxine hydrochloride

BP 2013

Jiangxi Tianxin Pharmaceutical Co., Ltd.

China

17

VD-31561-19

27/02/2024

Etoricoxib

NSX

Virdev intermediates Pvt. Ltd

India

18

VD-31562-19

27/02/2024

Lincomycin hydrochloride

EP 8

Topfond Pharmaceutical Co., Ltd

China

19

VD-31563-19

27/02/2024

Enalapril maleate

USP 35

Ultratech India Limited

India

20

VD-31564-19

27/02/2024

Alimemazine tartrate

EP 8

Sanofi Chimie

France

21

VD-31565-19

27/02/2024

Amisulpride

EP 9

Hubei Haosun Pharmaceutical Co., Ltd

China

22

VD-31566-19

27/02/2024

Amisulpride

EP 9

Hubei Haosun Pharmaceutical Co., Ltd

China

23

VD-31567-19

27/02/2024

Amisulpride

EP 9

Hubei Haosun Pharmaceutical Co., Ltd

China

24

VD-31569-19

27/02/2024

Cilostazol

USP 38

Glenmark Pharmaceuticals Ltd.

India

25

VD-31570-19

27/02/2024

Itraconazole pellets 22.0% w/w

NSX

Murli Krishna Pharma Pvt. Ltd.

India

26

VD-31571-19

27/02/2024

FenofibrateMicronized

EP 8

Olon S.p.A

Italy

27

VD-31572-19

27/02/2024

Gemfibrozil

USP 36

Zhejiang Excel Pharmaceutical Co., Ltd

China

28

VD-31573-19

27/02/2024

Nizatidine

USP 38

Korea biochem pharm

Korea

29

VD-31786-19

27/02/2024

Dexpanthenol

EP 7.0

DSM Nutritional Product Ltd.

Switzerland

30

VD-31787-19

27/02/2024

Clotrimazol

USP 38

Changzhou Yabang Pharmaceutical Co.,Ltd

China

31

VD-31789-19

27/02/2024

Isoniazid

BP 2014

Tianjin Handewei Pharmaceutical Co.,Ltd

China

32

VD-32203-19

27/02/2024

Flurbiprofen

USP 40

METROCHEM API PRIVATE LIMITED

Ấn Độ

33

VD-32204-19

27/02/2024

Celecoxib

USP 40

Aarti Drugs Limited

Ấn Độ

34

VD-31614-19

27/02/2024

Promethazin hydrocloride

USP 38

Ningbo honor chemtech Co., Ltd

China

35

VD-31614-19

27/02/2024

Promethazin hydrocloride

USP 38

Dandong Qianjin Pharmaceutical Material Co., Ltd

China

36

VD-31614-19

27/02/2024

Promethazin hydrocloride

EP 8.0

Egis Pharmaceuticals PLC

Hungary

37

VD-31615-19

27/02/2024

Methocarbamol

USP 40

Ningbo Smart Pharmaceutical Co., Ltd.

China

38

VD-31616-19

27/02/2024

Propranolol hydrocloride

BP 2016

Changzhou Yabang Pharmaceutical Co., Ltd.

China

39

VD-31617-19

27/02/2024

Desloratadin

EP 8.0

ABHILASHA PHARMA PVT. Ltd

India

40

VD-31617-19

27/02/2024

Desloratadin

TCCS

Morepen Laboratories Limited.

India

41

VD-31619-19

27/02/2024

Docusate natri

USP 38

EP7

BP2013

CYTEC INDUSTRIES INC.

USA

42

VD-31620-19

27/02/2024

Calcium lactate pentahydrate

BP 2016

Vasa Pharmachem Pvt. Ltd

India

43

VD-31620-19

27/02/2024

Calcium lactate pentahydrate

USP 40

Luoyang Longmen Pharmaceutical Co., LTD

China

44

VD-31620-19

27/02/2024

Thiamine hydrochloride

EP 8.0

DSM Nutritional Products GmbH

Germany

45

VD-31620-19

27/02/2024

Riboflavin sodium phosphate

USP 40

Harman Finochem Limited

India

46

VD-31620-19

27/02/2024

Riboflavin sodium phosphate

EP 8.0

DSM Nutritional Products France

France

47

VD-31620-19

27/02/2024

Pyridoxine hydrochloride

EP 8.0

DSM Nutritional Products GmbH

Germany

48

VD-31620-19

27/02/2024

Cholecalciferol

EP 8.0

DSM Nutritional Products France

France

49

VD-31620-19

27/02/2024

Cholecalciferol

USP 40

BASF SE

Germany

50

VD-31620-19

27/02/2024

Alpha tocopheryl acetate

EP 8.0

DSM Nutritional Products AG

Switzerland

51

VD-31620-19

27/02/2024

Nicotinamide

BP 2016

AMSAL CHEM PVT. LTD

India

52

VD-31620-19

27/02/2024

Dexpanthenol

EP 8.0

DSM Nutritional Products (UK) Ltd.

UK

53

VD-31620-19

27/02/2024

Dexpanthenol

EP 8.0

BASF SE

Germany

54

VD-31620-19

27/02/2024

Lysine hydrochloride

USP 40

Shreenath Chemicals

India

55

VD-31622-19

27/02/2024

Naphazoline Hydrochloride

USP 38

Precise Chemipharma PVT.LTD.

India

56

VD-31622-19

27/02/2024

Naphazoline Hydrochloride

EP 9.0, BP 2016, TCCS

Loba Feinchemie Gmbh

Austria

57

VD-31623-19

27/02/2024

Paracetamol

BP2016/USP40 /EP8.0

Anqiu Lu an Pharmaceutical Co., Ltd.

China

58

VD-31623-19

27/02/2024

Paracetamol

EP 8.0

Lianyungang Kangle

Pharmaceutical Co., Ltd.

China

59

VD-31612-19

27/02/2024

Adenosine

BP 2016/

EP 8.0/ USP 40

Prime European Therapeuticals S.P.A - Euticals S.P.A

Italia

60

VD-31618-19

27/02/2024

Digoxin

BP 2016/ EP8

Vital Laboratories Private Limited

India

61

VD-31618-19

27/02/2024

Digoxin

USP38/ BP 2016/ EP8

Alchem International Private Limited

India

62

VD-31618-19

27/02/2024

Digoxin

USP38/

BP 2016/ EP8

Deccan Nutraceuticals Private Limited

India

63

VD-31618-19

27/02/2024

Digoxin

USP38/

BP 2016/ EP8

Nobilus Ent Tomasz Kozluk (Nobilus Ent)

Poland

64

VD-31621-19

27/02/2024

Ketorolac trometamol

BP 2014

Recordati S.P.A

Italia

65

VD-31621-19

27/02/2024

Ketorolac trometamol

USP 38

QUÍMICA SINTÉTICA, S.A..

Spain

66

VD-31621-19

27/02/2024

Ketorolac trometamol

USP 38

Shangdong Newtime Pharmaceutical Co., Ltd

China

67

VD-31621-19

27/02/2024

Ketorolac trometamol

EP 8, BP 2014

Union Quimico Farmaceutica, S.A.

Spain

68

VD-31624-19

27/02/2024

Tobramycin sulfate

USP 40

Biovet JSC.

Bulgaria

69

VD-31624-19

27/02/2024

Tobramycin sulphate

USP 40

Xellia Pharmaceuticals ApS

Denmark

70

VD-31624-19

27/02/2024

Tobramycin sulfate

USP40/TCCS

LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO., LTD

China

71

VD-31751-19

27/02/2024

Ticegrelor

TC NSX

Glenmark Pharmaceuticals Ltd.

India

72

VD-31773-19

27/02/2024

Granisetron hydrochloride

TC NSX

Mustafa NevzatIlacSanayii A.S.

Turkey

73

VD-31819-19

27/02/2024

Alphachymotrypsin

USP 41

Enzymeking Biotechnology Co., Ltd

China

74

VD-31820-19

27/02/2024

Alphachymotrypsin

USP 41

Enzymeking Biotechnology Co., Ltd

China

75

VD-31821-19

27/02/2024

Alphachymotrypsin

USP 41

Enzymeking Biotechnology Co., Ltd

China

76

VD-31822-19

27/02/2024

AIphachymotrypsin

USP 41

Enzymeking Biotechnology Co., Ltd

China

77

VD-31823-19

27/02/2024

Etoricoxib

IP 2014

Metrochem Api Private Limited

India

78

VD-31824-19

27/02/2024

Alverin citrate

EP 8.0

Jiangsu Cale New Material Co., Ltd

China

79

VD-32297-19

27/02/2024

Sulfasalazine

USP38

Zhejiang Jiuzhou Pharmaceutical Co., Ltd

China

80

VD-32385-19

27/02/2024

Linezolid

TC NSX

Symed Labs Limited

India

81

VD-32386-19

27/02/2024

Lercanidipine hydrochloride

TC NSX

Glenmark Generics Limited

India

82

VD-32387-19

27/02/2024

Deferiprone

TC NSX

Aarti Industries Limited

India

83

VD-32449-19

27/02/2024

Ebastine

JP 16

Nactar Lifesciences Ltd

India

84

VD-31992-19

27/02/2024

Metformin hydrochloride

DĐVN IV

AURO LABORATORIES LIMITED

India

85

VD-31987-19

27/02/2024

Alphachymotrypsin

USP 38

Enzymeking Biotechnology Co., Ltd.

China

86

VD-31988-19

27/02/2024

Desloratadin

USP 40

MOREPEN LABORATORIES LIMITED

India

87

VD-31989-19

27/02/2024

Dextromethorphan hydrobromide

USP 40

Wockhardt Limited

India

88

VD-31990-19

27/02/2024

Paracetamol

EP 8.0

NovacylWuxi Pharmaceutical Co.Ltd

China

89

VD-31990-19

27/02/2024

Chlorpheniramine maleate

BP 2016

Supriya lifescience Ltd

India

90

VD-31991-19

27/02/2024

Loratadine

USP 38

VASUDHA PHARMA CHEM LTD

India

91

VD-31993-19

27/02/2024

Loperamide hydrochloride

USP 40

Vasudha Pharma Chem Limited

India

92

VD-31994-19

27/02/2024

Prednisolone

BP 2014

Tianjin Tianyao Pharmaceuticals Co., Ltd

China

93

VD-31995-19

27/02/2024

Dried ferrous sulfat

USP 41

Canton Laboratories PVT.Ltd

India

94

VD-31995-19

27/02/2024

Folic acid

EP 9.0

DSM Nutritional Products Ltd

Singapore

95

VD-31997-19

27/02/2024

Sodium benzoate

NF 30

Emerald Performance materials

USA

96

VD-31424-19

27/02/2024

Paracetamol

USP 35

Hebei Jiheng (Group) Pharmaceutical Co.,Ltd

China

97

VD-31425-19

27/02/2024

Fexofanadin hydroclirid

USP 35

Vasudha Pharma Chem Limited

India

98

VD-31426-19

27/02/2024

Cefdinir

USP 40

Parabolic Drugs Ltd.

India

99

VD-31427-19

27/02/2024

Cefdinir

USP 40

Parabolic Drugs Ltd.

India

100

VD-31428-19

27/02/2024

Cephalexin (dùng dưới dạng Cefalexin monohdrat)

BP 2013

Lupin Limited

India

101

VD-31429-19

27/02/2024

Cefadroxil (dùng dưới dạng cefadroxil monohydrat)

USP 37

DSM Sinochem Pharmaceuticals Spain S.A

Spain

102

VD-31430-19

27/02/2024

Cefadroxil (dùng dưới dạng cefadroxil monohydrat)

USP 37

DSM Sinochem Pharmaceuticals Spain S.A

Spain

103

VD-31432-19

27/02/2024

Magnesi lactat dihydrat

EP 7

Zhengzhou Ruipu Biological Engineering Co.,Ltd

China

104

VD-31432-19

27/02/2024

Pyridoxin hydroclorid

BP 2013

Jiangxi Tianxin Pharmaceutical Co., Ltd.

China

105

VD-31544-19

27/02/2024

Ebastine

BP 2013

Bal Pharma Limited

India

106

VD-31545-19

27/02/2024

Roxithromycin

EP 8

Zhejiang Guobang Pharmaceutical Co., Ltd

China

107

QLĐB-753-19

27/02/2022

Solifenacin succinate

EP 8.6

Medichem Manufacturing (Malta) Limited

Malta

108

QLĐB-754-19

27/02/2022

Solifenacin succinate

EP 8.6

Medichem Manufacturing (Malta) Limited

Malta

109

VD-31751-19

27/02/2024

Ticagrelor

TC NSX

Glenmark Pharmaceutical Limited

India

110

VD-31773-19

27/02/2024

Granisetron hydrochloride

TC NSX

Mustafa NevzatIlacSanayii A.S. - API Plant

Turkey

111

VD-31984-19

27/2/2024

Amlodipine besilate

EP 7

Ereros

Spain

112

VD-31591-19

27/02/2024

Acyclovir

USP 38

Zhejiane Zhebei Pharmaceutical Co.Ltd

China

113

VD-31592-19

27/02/2024

Amikacin sulfate

USP 38

ACS DobfarS.p.a

Italy

114

VD-31594-19

27/02/2024

Sitagliptin phosphate (dưới dạng monohydrate)

USP 39

HARMAN FINOCHEM LIMITED

India

115

VD-31595-19

27/02/2024

Sitagliptin phosphate (dưới dạng monohydrate)

USP 40

MSN Pharmachem Private Limited

India

116

VD-31596-19

27/02/2024

Thiocolchicoside

Nhà sản xuất

ZEON-HEALTH INDUSTRISE

India

117

VD-31597-19

27/02/2024

Gabapentin

USP 38

ZHEJIANG CHIRAL MEDICINE CHEMICALS CO., LTD.

China

118

VD-31598-19

27/02/2024

Hyoscine butylbromide

BP 2016

VITAL LABORATORIES PRIVATE LIMITED

India

119

VD-31600-19

27/02/2024

Sucralfate

USP 38

NORTHEAST PHARMACEUTICAL GROUP CO., LTD.

China

120

VD-31601-19

27/02/2024

Telmisartan

EP 8.0

JIANGSU ZHONGBANG PHARMACEUTICAL CO., LTD.

China

121

VD-31599-19

27/02/2024

Ezetimibe

USP 40

LUPIN LIMITED

India

122

VD-31599-19

27/02/2024

Atorvastatin calcium

USP 40

MOREPEN LABORATORIES LIMITED

India

123

VD-32510-19

20/03/2024

Miconazol nitrat

BP 2013

FarchemiaS.r.l.

Italy

124

VD-32509-19

20/03/2024

Sulfamethoxazol

BP 2013

Virchows

India

125

VD-32509-19

20/03/2024

Trimethoprim

BP 2013

SHOUGUANG FUKANG PHARMACEUTICAL CO., LTD

Trung Quốc

126

VD-32508-19

20/03/2024

Piracetam

BP 2012

Microsin S.R.L.

Romania

127

VD-31970-19

27/02/2024

Amoxicilin trihydrate

USP 37

DSM Anti-Infective India Limited

India

128

VD-31970-19

27/02/2024

Sulbactam pivoxil

NSX

Zhejiang Xinhua Pharmaceutical Co., Ltd

China

129

VD-31946-19

27/02/2024

Dihydroartemisinin

CP 2010

Hangzhou Viwa Co., Ltd.

China

130

VD-31946-19

27/02/2024

Piperaquine phosphate

CP 2015

Chongqing Kangle Pharma

China

131

VD-31947-19

27/02/2024

Oxacilin sodium monohydrate

EP 8

Aurobindo Pharma Limited

India

132

VD-31948-19

27/02/2024

Cefotaxim sodium

USP 39

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

China

133

VD-31949-19

27/02/2024

Cefuroxime axetil

USP 38

Nectar Lifesciences Ltd.

India

134

VD-31950-19

27/02/2024

Cefuroxime axetil

USP 38

Nectar Lifesciences Ltd.

India

135

VD-31951-19

27/02/2024

Sterile Glutathione Sodium Lyophilized

NSX

Wuxi Jida Pharmaceutical Co., Ltd.

China

136

VD-31952-19

27/02/2024

Loxoprofen sodium hydrate

JP XVI

Weihai Disu Pharmaceutical Co., Ltd

China

137

VD-31953-19

27/02/2024

Acid ascorbic

BP 2016

DSM Jiangshan Pharmaceutical (Jiangsu) Co., LTD

China

138

VD-31953-19

27/02/2024

Acid ascorbic

BP 2016

Shandong Luwei Pharmaceutical Co., LTD

China

139

VD-31954-19

27/02/2024

Amoxicillin trihydrate

USP 38

DSM Sinochem Pharmaceuticals India Private Limited

India

140

VD-31954-19

27/02/2024

Cloxacillin sodium

EP 8

DSM Sinochem Pharmaceuticals India Private Limited

India

141

VD-31955-19

27/02/2024

Cephalexin (dưới dạng Cephalexin monohydrate compacted)

USP 38

Zhejiang Anglikang Pharmaceutical Co., Ltd

China

142

VD-31956-19

27/02/2024

Pantoprazole sodium (sterile) (Sterile dry powder of Pantoprazole Sodium)

NSX

Sterile India Pvt., Ltd.

India

143

VD-31957-19

27/02/2024

RabeprazoleSodium Hydrate

EP 9

Metrochem API Private Limited

India

144

VD-31958-19

27/02/2024

Spiramycin

EP 8

Topfond Pharmaceutical Co., Ltd.

China

145

VD-31959-19

27/02/2024

Spiramycin

EP 7

Wuxi Fortune Pharmaceutical Co., Ltd

China

146

VD-31960-19

27/02/2024

Galantamine hydrobromide

EP 8

Indena S.p.A

Italy

147

VD-31962-19

27/02/2024

Phenoxymethylpenicillin Potassium

BP 2016

North China Pharmaceutical Co., Ltd.

China

148

VD-31963-19

27/02/2024

Carbazochrome Sodium sulfonate

JP XVI

Daito Pharmaceutical Co., Ltd.

Japan

149

VD-31964-19

27/02/2024

Carbazochrome Sodium sulfonate

JP XVI

Daito Pharmaceutical Co., Ltd.

Japan

150

VD-31966-19

27/02/2024

Spiramycin

EP 8

Wuxi Fortune Pharmaceutical Co., Ltd

China

151

VD-31967-19

27/02/2024

Spiramycin

EP 8

Wuxi Fortune Pharmaceutical Co., Ltd

China

152

VD-31968-19

27/02/2024

Ceftriaxone Sodium

USP 41

Covalent Laboratories Private Limited

India

153

VD-31969-19

27/02/2024

Pyridoxine hydrochloride

EP 7/USP 37

DSM Nutritional Products GmbH

Germany

154

VD3-22-19

20/3/2022

Dexamethasone acetate

USP 39

Zhejiang Xianju Pharmaceutical Co., Ltd.

China

155

VD3-22-19

20/3/2022

Nystatin

EP 8

VUAB Pharma a.s.

Czech Republic

156

VD-32524-19

20/03/2024

Cefixime trihydrate

USP 35

Nectar Lifesciences Ltd

India

157

VD-32525-19

20/03/2024

Cefixime trihydrate

USP 35

Nectar Lifesciences Ltd

India

158

VD-32527-19

20/03/2024

Amoxicillin trihydrate

BP 2014

Sinopharm Weiqida Pharmaceutical Co., Ltd

China

159

VD-32526-19

20/03/2024

Citicoline Sodium

CP 2010

Kaiping Genuine Biochemical Pharmaceutical Co., Ltd

China