Công văn 4882/QLD-ĐK năm 2019 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 đợt 164 do Cục Quản lý Dược ban hành

STT

Số giấy đăng ký lưu hành thuốc

Hết 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

GC-315-19

27/02/2024

Aciclovir

EP 9.0

Zhejiang Charioteer Pharmaceutical Co., Ltd.

China

2

GC-316-19

27/02/2024

Aciclovir

EP 9.0

Zhejiang Charioteer Pharmaceutical Co., Ltd.

China

3

VD-31509-19

27/02/2024

Acid Nalidixic

BP 2013

Unimark Remedies Ltd, Vapi

India

4

VD-31510-19

27/02/2024

Bromhexin hydroclorid

EP 8.0

Orex pharma Pvt. Ltd.

India

5

VD-31511-19

27/02/2024

Clorpheniramin maleat

EP 7.0

Supriys Lifescience TLD

India

6

VD-31512-19

27/02/2024

Desloratadin

EP 8.0

Cadila pharmaceuticals limited

India

7

VD-31513-19

27/02/2024

Paracetamol

BP 2014

Anqiu Lu’an Pharmaceutical Co.,Ltd

China

8

VD-31514-19

27/02/2024

Dexclorpheniramin maleat

USP 35

Nivedita Chemicals Pvt. Ltd

India

9

VD-31515-19

27/02/2024

Dextromethorphan hydrobromid

USP 35

Dr.Reddy’s JN Laboratiries Limited

India

10

VD-31515-19

27/02/2024

Dextromethorphan hydrobromid

USP 35

Dr.Reddy’s JN Laboratiries Limited

India

11

VD-31603-19

27/02/2024

Ibuprofen

BP 2018

IOL Chemicals And Pharmaceuticals Limited.

India

12

VD-31604-19

27/02/2024

Aluminium Phosphate (Nhôm phosphat gel 20%)

EP 8.0

SRL Pharma GmbH

Germany

13

VD-31605-19

27/02/2024

Paracetamol

BP 2014

Anqiu Lu'an Pharmaceutical Co., Ltd.

China

14

VD-31606-19

27/02/2024

Desloratadine

EP 8.0

Morepen Laboratories Limited

India

15

VD-31607-19

27/02/2024

Celecoxib

USP 38

Hetero Drugs Limited (Unit-IX).

India

16

VD-31608-19

27/02/2024

Enalapril maleate

USP 38

Zhejiang Changming Pharmaceutical Co., Ltd

China

17

VD-31608-19

27/02/2024

Hydrochlorothiazide

USP 38

CTX Lifesciences Ltd

India

18

VD-31609-19

27/02/2024

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd.

China

19

VD-31609-19

27/02/2024

Caffeine

EP 8.0

Aarti Industries Limited

India

20

VD-31610-19

27/02/2024

Chlorphenesin carbamate

JP XVI

Synthokem Labs Private Limited.

India

21

VD-31611-19

27/02/2024

Zopiclone

EP 8.8

Calyx Chemicals and Pharmaceuticals Limited

India

22

VD-31632-19

27/02/2024

Olmesartan medoxomil

USP 38

VERDANT LIFE SCIENCES PVT. LTD.

India

23

VD-31632-19

27/02/2024

Hydrochlorothiazide

USP 39

UNITED PHARMA INDUSTRIES CO., LTD

China

24

VD-31633-19

27/02/2024

Meloxicam

BP 2015

PARTH OVERSEAS

India

25

VD-31634-19

27/02/2024

Erdosteine

NSX

UNITED PHARMA INDUSTRIES CO., LTD.

China

26

VD-31635-19

27/02/2024

Quetiapine fumarate

IP 2014

HETERO DRUGS LIMITED

India

27

VD-31636-19

27/02/2024

Valsartan

USP 38

UNITED PHARMA INDUSTRIES CO., LTD.

China

28

VD-31637-19

27/02/2024

Tenofovir disoproxil fumarate

NSX

ZHEJIANG SUPOR PHARMACEUTICALS CO., LTD.

China

29

VD-31842-19

27/02/2024

Chymotrypsin

USP 38

Beijing Geyuantianrun Bio-Tech Co., Ltd

China

30

VD-31843-19

27/02/2024

Paracetamol

EP 8

Novacyl (Wuxi) pharmaceutical Co., Ltd

China

31

VD-31843-19

27/02/2024

Paracetamol

EP 8

SpecGx LLC Raleigh Pharmaceutical Plant

USA

32

VD-31843-19

27/02/2024

Cafein anhydrous

EP 8

Siegfried PharmaChemikalen Minden GmbH

Germany

33

VD-31844-19

27/02/2024

Lumefantrin

CP 2010

Zhejiang Wantai Chemical Pharmaceutical Co., Ltd.

China

34

VD-31845-19

27/02/2024

Fenofibrat

EP 7

Zhejiang Excel Pharmaceutical Co., Ltd

China

35

VD-31846-19

27/02/2024

Azithromycin dihydrat

EP 8

HEC PHARM Co., Ltd

China

36

VD-31986-19

27/02/2024

Spiramycin base

EP 7

Henan topfond pharmaceutical.

China

37

VD-31811-19

27/02/2024

Esomeprazole pellets 8.5% w/w

NSX

Lee Pharma Limited

India

38

VD-31812-19

27/02/2024

Ivermectin

EP 7.0

Iffect Chemphar Co., Ltd

China

39

VD-31813-19

27/02/2024

Alimemazine tartrate

BP 2013

R L Fine Chem Pvt Ltd

India

40

VD-31814-19

27/02/2024

Oxomemazine hydrochloride (Oxomemazine HCl)

NSX

Taro Pharmaceutical Industries Ltd

Israel

41

VD-31814-19

27/02/2024

Guaifenesin

USP 34

Synthokem Labs Private Limited (Unit-II)

India

42

VD-31815-19

27/02/2024

Acetaminophen

USP 38

Novacyl (Wuxi) Pharmaceutical Co., Ltd

China

43

VD-31815-19

27/02/2024

Acetaminophen

USP 38

Mallinckrodt Inc

USA

44

VD-31815-19

27/02/2024

Diphenhydramine hydrochloride

BP 2013

Ji’nan Orgachem Pharmaceutical Co., Ltd

China

45

VD-31912-19

27/02/2024

N-Acetyl-L-Cysteine (Acetylcystein)

USP 38

Wuhan Grand Hoyo Co., Ltd

China

46

VD-31913-19

27/02/2024

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd

China

47

VD-31914-19

27/02/2024

Sultamicilin tosilat dihydrat

EP 8.0

Mustafa Nevzat Ilac Sanayi A.S. - Hammadde Uretim Tesisi

Turkey

48

VD-31915-19

27/02/2024

Cefalexin monohydrat compacted

BP 2014

Zhejiang Anglikang Pharmaceutical Co., Ltd.

China

49

VD-31916-19

27/02/2024

Cefalexin monohydrat compacted

BP 2014

Zhejiang Anglikang Pharmaceutical Co., Ltd.

China

50

VD-31917-19

27/02/2024

Dextromethorphan hydrobromid

USP 38

Divi's Laboratories Limited

India

51

VD-31918-19

27/02/2024

Diclofenac natri (Diclofenac sodium)

BP 2012

Suzhou Ausun Chemical Co., Ltd.

China

52

VD-31919-19

27/02/2024

Sitagliptin phosphat monohydrat

NSX

Beijing Huikang Boyuan Chemical Tech Co., Ltd.

China

53

VD-31920-19

27/02/2024

Roxithromycin

EP 7.0

Zhejiang Guobang Pharmaceutical Co., Ltd

China

54

VD-31922-19

27/02/2024

Diosmectite

NSX

Shandong Xianhe Pharmaceutical Co., Ltd

China

55

VD-31923-19

27/02/2024

Methocarbamol

USP 38 +NSX

Ningbo Smart Pharmaceutical Co., Ltd

China

56

VD-31924-19

27/02/2024

Clopidogrel bisulfat

USP 38

Dymes Pharmachem Limited

India

57

VD-31924-19

27/02/2024

Clopidogrel bisulfat

USP 38

Smilax Laboratories Limited

India

58

VD-31925-19

27/02/2024

Fexofenadin hydroclorid

USP 38

Vasudha Pharma Chem Limited

India

59

VD-31926-19

27/02/2024

N-Acetyl-DL-Leucin

NSX

Ningbo Yuanfa Bioengineering Co., Ltd

China

60

VD-32024-19

27/02/2024

Captopril

USP 40

Changzhou Pharmaceutical Factory

China

61

VD-32024-19

27/02/2024

Hydroclorothiazid

EP 8.0

Changzhou Pharmaceutical Factory

China

62

VD-32025-19

27/02/2024

Enalapril maleat

USP 39

Zhejiang Huahai Pharmaceutical Co., Ltd

China

63

VD-32025-19

27/02/2024

Hydroclorothiazid

EP 8.0

Changzhou Pharmaceutical Factory

China

64

VD-32295-19

27/02/2024

Amoxicilin trihydrat compacted

NSX

Sinopharm Weiqida Pharmaceutical Co., Ltd

China

65

VD-32296-19

27/02/2024

Calci carbonat (dưới dạng Scoralite DC 90ST)

NSX

Scora

France

66

VD-32296-19

27/02/2024

Vitamin D3 (100.000 IU/g)

USP 38

Xiamen Kingdomway Group Company

China

67

VD-31971-19

27/02/2024

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd

China

68

VD-31972-19

27/02/2024

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd

China

69

VD-31974-19

27/02/2024

Cefixime trihydrate

USP 34

Aurobindo Pharma LTD

India

70

VD-31975-19

27/02/2024

Cefotaxime sodium

USP 40

Nectar Lifesciences Ltd

India

71

VD-31976-19

27/02/2024

Ceftriaxone sodium

USP 38

Nectar Lifesciences Ltd

India

72

VD-31977-19

27/02/2024

Cefuroxime axetil

USP 36

Nectar Lifesciences Ltd

India

73

VD-31978-19

27/02/2024

Cefuroxime axetil

USP 36

Nectar Lifesciences Ltd

India

74

VD-31979-19

27/02/2024

Erythromycin ethylsuccinate

BP 2017

Linaria Chemicals (ThaiLand) Limited

Thailand

75

VD-31980-19

27/02/2024

Ursodeoxycholic acid

USP 36

Sichuan Xieli Pharmaceutical Co., LTD

China

76

VD-31982-19

27/02/2024

Sulfamethoxazole

BP 2013

Virchow Laboratories Limited

India

77

VD-31982-19

27/02/2024

Trimethoprim

BP 2013

Shouguang Fukang Pharmaceutical Co., LTD

China

78

VD-32031-19

27/02/2024

Adrenaline

EP 8.0

Wuhan Wuyao Pharmaceutical Co., Ltd.

China

79

VD-32033-19

27/02/2024

Nicardipine hydrochloride

USP 38

Lusochimica S.p.a

Italy

80

VD-32034-19

27/02/2024

Amikacine sulfate

USP 40

Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.

China

81

VD-32035-19

27/02/2024

Mesalamine

USP 38

D.K.Pharmachem Pvt.Ltd

India

82

VD-32036-19

27/02/2024

Mesalamine

USP 38

D.K.Pharmachem Pvt.Ltd

India

83

VD-32037-19

27/02/2024

Methylprednisolone

USP 39

Zhejiang Xianju Pharmaceutical Co.LTD

China

84

VD-32120-19

27/02/2024

Tenoxicam

EP 7.0

Nantong Jinghua Pharmaceutical Co., Ltd.

China

85

VD-32118-19

27/02/2024

Calcium folinate

EP 8

Biofer S.p.A

Italy

86

VD-32117-19

27/02/2024

Calcium folinate

EP 8

Biofer S.p.A

Italy

87

VD-32119-19

27/02/2024

Gel nhôm phosphat 20% (Aluminum phosphate gel)

EP 8.0

SPI Pharma.

France

88

VD-32121-19

27/02/2024

Ascorbic Acid

USP 40

DSM Nutritional Products Ltd.

United Kingdom

89

VD-32205-19

27/02/2024

Carbazochrome sodium sulfonate hydrate

JP XVII

Daito Pharmaceutical Co., Ltd.

Japan

90

VD-32206-19

27/02/2024

Mefenamic Acid

BP 2015

BAOJI TIANXIN PHARMACEUTICAL CO., LTD

China

91

VD-32207-19

27/02/2024

Magnesium laclate dihydrate

NSX

MOEHS CANTABRA SL

Spain

92

VD-32207-19

27/02/2024

Magnesium pidolate

NSX

ORGANOTECHNIE

France

93

VD-32207-19

27/02/2024

Pyridoxine hydrochloride

NSX

DSM NUTRITIONAL PRODUCTS GMBH

Germany

94

VD-32208-19

27/02/2024

Fexofenadine HCl

EP 8.6

Sanofi-Aventis Deutschland GmbH

Germany

95

VD-32209-19

27/02/2024

Alimemazine tartrate

EP 9.2

SANOFI CHIMIE

France

96

VD-32214-19

27/02/2024

Diclofenac diethylamine

BP 2013

Amoli Organics Pvt,Ltd

India

97

VD-32217-19

27/02/2024

Montelukast

USP 39

Metrochem Api Private Limited

India

98

VD-32218-19

27/02/2024

Paracetamol

BP 2017

Anqiu Lu’an Pharmaceutical Co., Ltd.

China

99

VD-32211-19

27/02/2024

Orlistat

USP 38

CHONGQING ZEIN PHARMACEUTICAL CO., LTD.

China

100

VD-32212-19

27/02/2024

Orlistat

USP 38

CHONGQING ZEIN PHARMACEUTICAL CO., LTD.

China

101

VD-32216-19

27/02/2024

Mirtazapine hemihydrate

EP 9.0

ZHEJIANG LIAOYUAN PHARMACEUTICAL CO., LTD

China

102

VD-32219-19

27/02/2024

Alpha lipoic Acid

USP 38

PYSON CO.,LTD.

China

103

VD-32213-19

27/02/2024

Calcipotriol

BP 2013

Century Pharmaceuticals Ltd

India

104

VD-32213-19

27/02/2024

Betamethasone dipropionate

BP 2013

Tianjin Tianyao Pharmaceuticals Co., Ltd.

China

105

VD-32247-19

27/02/2024

Cefradine

USP 40

Orchid Pharma Ltd.

India

106

VD-32248-19

27/02/2024

Cefpodoxim proxetil

USP 38

Orchid Pharma Ltd.

India

107

VD-32249-19

27/02/2024

Cefpodoxim proxetil

USP 40

COVALENT LABORATORIES PRIVATE LIMITED

India

108

VD-32250-19

27/02/2024

Cefpodoxim proxetil

USP 40

COVALENT LABORATORIES PRIVATE LIMITED

India

109

VD-32251-19

27/02/2024

Cefpodoxim proxetil

USP 40

COVALENT LABORATORIES PRIVATE LIMITED

India

110

VD-32252-19

27/02/2024

Cefpodoxim proxetil

USP 40

COVALENT LABORATORIES PRIVATE LIMITED

India

111

VD-32253-19

27/02/2024

Cefaclor monohydrate

USP 40

LUPIN PHARMACEUTICALS, INC

India

112

VD-32454-19

27/02/2024

Netilmicin sulfate

USP 41

Wuxi Fortune Pharmaceutical Co., Ltd.

China

113

VD-32455-19

27/02/2024

Netilmicin sulfate

USP 41

Wuxi Fortune Pharmaceutical Co., Ltd.

China

114

VD-32456-19

27/02/2024

Sodium chloride

USP 39

Dominion Salt Limited

New Zealand

115

VD-32456-19

27/02/2024

Sodium chloride

BP 2014

Hebei Huachen Pharmaceutical Co., Ltd

China

116

VD-32457-19

27/02/2024

Sodium chloride

USP 39

Dominion Salt Limited

New Zealand

117

VD-32432-19

27/02/2024

Zoledronic acid monohydrate

NSX

Ifotam Co., Ltd.

Poland

118

VD-32433-19

27/02/2024

Zoledronic acid monohydrate

NSX

Ifotam Co., Ltd.

Poland

119

VD-32434-19

27/02/2024

Dobutamine HCl (Dobutamin HCl)

NSX

Recordati Industria Chimica E Farmaceutica S.p.A - Italia

Italia

120

VD-32435-19

27/02/2024

Isosorbide dinitrat

NSX

Shandong Keyuan Pharmaceutical Co., Ltd - China

China

121

VD-32436-19

27/02/2024

Nicardipine hydrochloride

USP 40+ NSX

Apothecon Pharmaceuticals PVT. LTD., - India

India

122

VD-32437-19

27/02/2024

Nicardipine hydrochloride

USP 40+ NSX

Apothecon Pharmaceuticals PVT. LTD., - India

India

123

VD-32438-19

27/02/2024

Tobramycin sulphate

USP 40 + NSX

Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd

China