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BỘ Y TẾ |
CỘNG HÒA XÃ HỘI
CHỦ NGHĨA VIỆT NAM |
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Số: 4148/QLD-ĐK |
Hà Nội, ngày 27 tháng 03 năm 2019 |
Kính gửi: Các cơ sở đăng ký, sản xuất thuốc trong nước
Căn cứ Luật dược số 105/2016/QH13 ngày 06/4/2016;
Căn cứ Nghị định 54/2017/NĐ-CP ngày 08/5/2017;
Căn cứ Nghị định 155/2018/NĐ-CP ngày 12/11/2018;
Cục Quản lý Dược thông báo:
Công bố Danh mục nguyên liệu 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 theo danh mục đính kèm (Đợt 164).
Danh mục nguyên liệu làm thuốc được công bố nêu trên đăng tải trên trang thông tin điện tử của Cục Quản lý Dược tại địa chỉ: www.dav.gov.vn.
Cục Quản lý Dược thông báo để các công ty sản xuất biết và thực hiện.
Nơi nhận: - Như trên; - CT. Vũ Tuấn Cường (để b/c) ; - Tổng Cục Hải Quan (để phối hợp); - Website Cục QLD; - Lưu: VT, ĐKT(V).
TUQ. CỤC TRƯỞNG TRƯỞNG PHÒNG ĐĂNG KÝ THUỐC Nguyễn Huy Hùng
DANH MỤC
NGUYÊN LIỆU 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) Đính kèm công văn số 4148/QLD-ĐK ngày 27 tháng 3 năm 2019.
STT
Số giấy đăng ký lưu hành thuốc
Hết hiệu lực đăng ký lưu hành thuốc
Tên nguyên liệu làm thuốc được công bố
Tiêu chuẩn chất lượng nguyên liệu
Tên cơ sở sản xuất nguyên liệu
Tên nước sản xuất nguyên liệu
1
VD-32350-19
27/2/2024
Meloxicam
EP 8.0
Zhejiang Excel Pharmaceutical Co., Ltd
China
2
VD-32351-19
27/2/2024
Atorvastatin Calcium Trihydrate
USP 36
Morepen Laboratories Limited
India
3
QLĐB-758-19
27/2/2022
Febuxostat
TCNSX
Metrochem Api Private Limited.
India
4
VD-31443-19
27/2/2024
Dried Aluminnium Hydroxide Gel
USP 38
IL-Yang Pharma Co., Ltd
Korea
5
VD-31443-19
27/2/2024
Magnesium Hydroxide
USP 38
IL-Yang Pharma Co., Ltd
Korea
6
VD-31443-19
27/2/2024
Simethicone powder
NSX
Dasan Pharmaceutical Co., Ltd
Korea
7
VD-31444-19
27/2/2024
Losartan Potassium
USP 38
Zhejiang Huahai Pharmaceutical Co., Ltd.
China
8
VD-31445-19
27/2/2024
Telmisartan
BP 2014
Metrochem API Private Limited
India
9
VD-31445-19
27/2/2024
Hydrochlorothiazide
EP 8.0
Suzhou Lixin Pharmaceutical Co., Ltd
China
10
VD-31446-19
27/2/2024
Ursodeoxycholic Acid
EP 8.0
Sichuan Xieli Pharmaceutical Co.,Ltd.
China
11
VD-31453-19
27/2/2024
Methylprednisolon
USP 36
TIANJIN TIANYAO PHARMACEUTICALS CO., LTD
China
12
VD-32157-19
27/2/2024
Loratadine
USP 39
CADILA PHARMACEUTICALS LIMITED
India
13
VD-32157-19
27/2/2024
Loratadine
USP 39
MOREPEN LABORATORIES LIMITED
India
14
VD-32158-19
27/2/2024
Montelukast sodium
USP 39
MOREPEN LABORATORIES LIMITED
India
15
VD-32159-19
27/2/2024
Doxycycline hyclate
USP 38
HEBEI DONGFENG PHARMACEUTICAL CO., LTD.
China
16
VD-32160-19
27/2/2024
Cetirizine hydrochloride
EP 9.0
SUPRIYA LIFESCIENCE LIMITED
India
17
VD-32161-19
27/2/2024
Cefpodoxim (dưới dạng Cefpodoxim proxetil)
USP 40
Parabolic Drugs Limited
India
18
VD-32162-19
27/2/2024
Cefaclor (dưới dạng cefaclor monohydrat)
USP 38
ACS Dobfar S.p.a.
Italy
19
VD-32163-19
27/2/2024
Amoxicilin (dưới dạng amoxicilin trihydrat)
BP 2014
Henan Lvyuan Pharmaceutical Co., Ltd
China
20
VD-32164-19
27/2/2024
Ampicilin (dưới dạng ampicilin trihydrat)
BP 2016
Henan Lvyuan Pharmaceutical Co., Ltd
China
21
VD-32304-19
27/2/2024
Cinnarizine
EP 8.0
Ray Chemicals PVT.LTD
India
22
VD-32305-19
27/2/2024
Flunarizine hydrochloride
EP 8.0
Weihai Disu Pharmaceutical Co., Ltd
China
23
VD-32306-19
27/2/2024
Meloxicam
BP 2017
Apex Healthcare Limited
India
24
VD-32307-19
27/2/2024
Erythromycin ethylsuccinate
USP 38
Huangshi Shixing Pharmaceutical Co., Ltd
China
25
VD-32308-19
27/2/2024
Esomeprazole magnesium dihydrat pellets 8,5%
TCNSX
Spansules Formulations
India
26
VD-32309-19
27/2/2024
Ambroxol hydrochloride
EP 8.0
Hangzhou Deli Chemical Co., Ltd
China
27
VD-32310-19
27/2/2024
Sildenafil citrate
USP 40
Rakshit Pharmaceuticals Limited
India
28
VD-32311-19
27/2/2024
Natamycin
USP 38
Pucheng Lifecome Biochemistry Co., Ltd
China
29
VD-32312-19
27/2/2024
L-Omithine L-Aspartate
TCNSX
Ningbo Yuanfa Bioengineering Co., LTD
China
30
VD-32313-19
27/2/2024
Ascorbic Acid
USP 38
CSPC Weisheng Pharmaceutical (Shijiazhuang) Co., Ltd
China
31
VD-32053-19
27/2/2024
Berberin clorid
JP 16
Northeast Pharmaceutical Group Co., Ltd
China
32
VD-32054-19
27/2/2024
Celecoxib
USP 41
Aarti Drugs Limited
India
33
VD-32055-19
27/2/2024
Meloxicam
BP 2015
Apex Healthcare Limited
India
34
QLĐB-745-19
27/2/2022
Tenofovir disoproxil fumarat
TCNSX
Zhejiang Supor Pharmaceuticals Co., Ltd.
China
35
VD-32079-19
27/2/2024
Paracetamol
BP 2016
ANQIU LU’AN PHARMACEUTICAL CO., LTD
China
36
VD-32079-19
27/2/2024
Ibuprofen
USP 40
BASF SOUTH EAST PTE. LTD
USA
37
VD-32080-19
27/2/2024
Vitamin C
USP 36
ALAND (JIANGSU) NUTRACEUTICAL CO., LTD.
China
38
VD-31651-19
27/2/2024
Triamcinolone acetonide
USP 38
Zhejiang Xianju Pharmaceutical Co., Ltd
China
39
VD-32254-19
27/2/2024
Cefpodoxime proxetil
USP 36
Dhanuka laboratories limited
India
40
VD-32255-19
27/2/2024
Fluocinolone acetonide
USP 38
Shandong Taihua Bio. & Tech Co.Ltd
China
41
VD-32255-19
27/2/2024
Neomycin sulfate
USP 39
Sichuan Long March Pharmaceutical Co., Ltd
China
42
VD-32256-19
27/2/2024
Cefalexin monohydrate
USP 37
Orchid Chemicals & Pharmaceuticals Ltd
India
43
VD-32257-19
27/2/2024
Mefenamic Acid
BP 2015
Baoji Tianxin Pharmaceutical Co., Ltd
China
44
VD-32258-19
27/2/2024
Celecoxib
USP 38
Kekule Pharma Limited
India
45
VD-32259-19
27/2/2024
Clotrimazole
USP 38
Changzhou Yabang Pharmaceutical Co., Ltd.
China
46
VD-32260-19
27/2/2024
Finasteride
USP 38
MSN Laboratories Private Limited
India
47
VD-32261-19
27/2/2024
Gabapentin
USP 38
Jiangxi Synergy Pharmaceutical Co, Ltd.
China
48
VD-32262-19
27/2/2024
Nizatidine
USP 38
Shasun Pharmaceuticals Limited
India
49
VD-32263-19
27/2/2024
Cefprozil monohydrate
USP 40
Covalent Laboratories Private Limited
India
50
VD-32264-19
27/2/2024
Desloratadine
TCNSX
Morepen Laboratories Limited
India
51
VD-32372-19
27/2/2024
Fexofenadine HCl
USP 37
Sreekara Organics.
India
52
VD-32373-19
27/2/2024
Cefixime trihydrate
USP 38
Covalent Laboratories Private Limited.
India
53
VD-32468-19
27/2/2024
Esomeprazole magnesium trihydrat pellets 8,5% w/w
TCNSX
Murli Krishna Pharma Pvt. Ltd.
India
54
VD-32469-19
27/2/2024
Valsartan
USP 38
Smilax Laboratories Limited.
India
55
VD-32467-19
27/2/2024
Rosuvastatin calcium
EP 9.0
Morepen Laboratories Limited
India
56
VD-32474-19
27/2/2024
Cefaclor monohydrate
USP 37
Lupin Limited
India
57
VD-32475-19
27/2/2024
Racecadotril
Ph.Eur 8.0
Rampex Labs PVT. Ltd
India
58
VD-32476-19
27/2/2024
Cefaclor monohydrate
USP 38
Lupin Limited
India
59
VD-32477-19
27/2/2024
Cefpodoxime proxetil
USP 38
Dhanuka Laboratories Limited
India
60
VD-32478-19
27/2/2024
Etoricoxib
TCNSX
Cadila Healthcare Limited
India
61
VD-32479-19
27/2/2024
Etodolac
USP 38
Kreative Organics Private Limited
India
62
VD-32481-19
27/2/2024
Thiocolchicoside
TCNSX
India Glycols Limited
India
63
VD-32482-19
27/2/2024
Thiocolchicoside
TCNSX
India Glycols Limited
India
64
VD-32483-19
27/2/2024
Montelukast sodium
USP 36
Unimark Remedies Ltd.
India
65
VD-32484-19
27/2/2024
Cefpodoxime proxetil
USP 36
Covalent Laboratories Private Limited
India
66
VD-32485-19
27/2/2024
Alphachymotrypsin
USP 38
Ningbo Linzyme Biosciences Co, Ltd
China
67
VD-32005-19
27/2/2024
Cefotiam (mix Cefotiam hydroclorid and Natri Carbonat with ratio 1:0,242)
TCNSX
Kyongbo Pharmaceutical Co., Ltd.
Korea
68
VD-32006-19
27/2/2024
Chlorhexidine gluconate solution 20%
BP 2016
Shaanxi Dasheng Pharmaceutical Tech Co.,Ltd
China
69
VD-32007-19
27/2/2024
Ciclopirox olamine
USP 39
Shanghai Pharma Group Changzhou Kony Pharmaceutical Co., Ltd.
China
70
VD-32008-19
27/2/2024
Ciclopirox
USP 39
Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd
China
71
VD-32009-19
27/2/2024
Amoxicillin Sodium with Potassium Clavulanate (Blend Sterile) (5:1)
TCNSX
Sinopharm Weiqida Pharmaceutical Co., Ltd.
China
72
VD-32011-19
27/2/2024
Diclofenac diethylamine
BP 2016
Amoli Organics Pvt. Ltd.
India
73
VD-32012-19
27/2/2024
Fluocinolone acetonide
BP 2015
Shangdong Taihua Bio & Tech Co., Ltd
China
74
VD-32014-19
27/2/2024
Terbinafine hydrochloride
EP 9
Shandong Boyuan Pharmaceutical Co., Ltd
China
75
VD-32016-19
27/2/2024
Lidocaine
USP 38
MOEHS BCN, S.L
Spain
76
VD-32017-19
27/2/2024
Povidone Iodine
USP 38
ISP (Singapore) Pte Ltd
US
77
VD-32018-19
27/2/2024
Povidone Iodine
USP 38
Boai NKY Pharmaceuticals Ltd.
China
78
VD-32019-19
27/2/2024
Povidone Iodine
USP 38
Boai NKY Pharmaceuticals Ltd.
China
79
VD-32020-19
27/2/2024
Cefamandole nafate with Sodium carbonate Sterile with ratio 1:0.063
TCNSX
China Union Chempharma (Suzhou) Co.,Ltd
China
80
VD-32021-19
27/2/2024
Cefuroxime sodium sterile
USP 38
Shenzhen Salubris Pharmaceuticals Co., Ltd
China
81
VD-32022-19
27/2/2024
Cefotaxime sodium sterile
USP 38
Harbin Pharmaceutical Group Co., Ltd. General Pharm Factory
China
82
VD-32023-19
27/2/2024
Methylene blue
USP 38
Anmol Chemicals
India
83
VD-32466-19
27/2/2024
Lacidipin
BP 2016
Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd
China
84
QLĐB-743-19
27/2/2022
Tenofovir disoproxil fumarate
TCNSX
Zhejiang Supor Pharmaceuticals Co., Ltd.
P.R.China
85
VD-32428-19
27/2/2024
Cefixim trihydrat
USP 38
Covalent Laboratories Private Limited.
India
86
VD-32220-19
27/2/2024
Acetaminophen
BP 2018
ANQIU LU’AN PHARMACEUTICAL CO., LTD
China
87
VD-32221-19
27/2/2024
Verapamil hydrochloride
USP 38
THE CENTRAL PHARMACEUTICAL CO., LTD
China
88
VD-32222-19
27/2/2024
Celecoxib
USP 38
AARTI DRUGS LIMITED
India
89
VD-32223-19
27/2/2024
Alphachymotrypsin
USP 38
BEIJING GEYUANTIANRUN BIO-TECH CO.,LTD
China
90
VD-32224-19
27/2/2024
Fluvoxamine maleate
BP 2016
VASUDHA PHARMA CHEM LIMITED
India
91
VD-32226-19
27/2/2024
Prednison
USP 38
HENAN LIHUA PHARMACEUTICAL CO., LTD
China
92
VD-32227-19
27/2/2024
Etodolac
USP 38
ZHEJIANG DONGDONG PHARMACEUTICAL CO., LTD
China
93
VD-32228-19
27/2/2024
Paracetamol
BP 2016
ANQIU LU’AN PHARMACEUTICAL CO., LTD
China
94
VD-32229-19
27/2/2024
Vitamin E (d-alpha tocopheryl acetat)
USP 38
ZHEJIANG WORLDBESTVE BIOTECHNOLOGY CO., LTD
China
95
VD-32230-19
27/2/2024
Ciprofibrate
BP 2016
INNOVA PHARMACTIVE PVT.LTD
India
96
QLĐB-749-19
27/2/2022
Tenofovir disoproxil fumarat
IP 2016
HETERO LABS LIMITED
India
97
VD-32314-19
27/2/2024
Nebivolol hydrochloride
TCNSX
Hetero Drugs Limited
India
98
VD-32315-19
27/2/2024
Ambroxol hydrochloride
BP 2016
Ami Lifesciences Pvt. Ltd
India
99
VD-32316-19
27/2/2024
Ambroxol hydrochloride
BP 2016
Ami Lifesciences Pvt. Ltd
India
100
VD-32317-19
27/2/2024
Quinapril hydrochloride
USP 38
Aarti Industries Limited
India
101
VD-32317-19
27/2/2024
Hydrochlorothiazide
USP 38
CTX Lifesciences Pvt Ltd
India
102
VD-32318-19
27/2/2024
Quinapril hydrochloride
USP 38
Aarti Industries Limited
India
103
VD-32318-19
27/2/2024
Hydrochlorothiazide
USP 38
CTX Lifesciences Pvt Ltd
India
104
VD-32319-19
27/2/2024
Baclofen
USP 39
SNA Healthcare Pvt. Ltd
India
105
VD-32320-19
27/2/2024
Nevirapine
USP 34
Hetero Labs Limited (Unit-IX)
India
106
VD-32322-19
27/2/2024
Candesartan cilexetil
EP 8
Zhuhai Rundu Pharmaceutical Co., Ltd
China
107
VD-32322-19
27/2/2024
Hydrochlorothiazide
USP 38
CTX Lifesciences Pvt Ltd
India
108
VD-32323-19
27/2/2024
Desloratadine
EP 8
Morepen Laboratories Limited
India
109
VD-32324-19
27/2/2024
Dextromethorphan hydrobromide
USP 38
Wockhardt Limited
India
110
VD-32325-19
27/2/2024
Ivermectin
USP 38
Zhejiang Hisun Pharmaceutical Co., Ltd
China
111
VD-32326-19
27/2/2024
Ivermectin
USP 38
Zhejiang Hisun Pharmaceutical Co., Ltd
China
112
VD-32327-19
27/2/2024
Fexofenadine hydrochloride
USP 38
Virupaksha Organics Limited
India
113
VD-32328-19
27/2/2024
Irbersartan
USP 38
Hangzhou Starshine Pharmaceutical Co., LTD
China
114
VD-32328-19
27/2/2024
Hydrochlorothiazide
USP 38
CTX Lifesciences Pvt Ltd
India
115
VD-32329-19
27/2/2024
Clindamycin hydrochloride
USP 38
Nanyang Pukang Pharmaceutical Co., Ltd
China
116
VD-32330-19
27/2/2024
Clindamycin hydrochloride
USP 38
Nanyang Pukang Pharmaceutical Co., Ltd
China
117
VD-32331-19
27/2/2024
Flavoxate hydrochloride
BP 2014
Ami Lifesciences Pvt., Ltd
India
118
VD-32332-19
27/2/2024
Pantoprazole sodium sesquihydrate
USP 37
Smilax Laboratories Limited
India
119
VD-32333-19
27/2/2024
Naproxen sodium
USP 38
Divi’s Laboratories Limited
India
120
VD-32334-19
27/2/2024
Mosapride citrate dihydrate
JP 17
Symed Labs Limited (Unit-II)
India
121
VD-32335-19
27/2/2024
Sildenafil citrate
USP 38
Yashica Pharmaceuticals Pvt. Ltd
India
122
VD-32336-19
27/2/2024
Sildenafil ciữate
USP 38
Yashica Pharmaceuticals Pvt. Ltd
India
123
VD-32337-19
27/2/2024
Alpha Lipoic acid
USP 38
Suzhou Fushilai Pharmaceutical Co., Ltd
China
124
VD-32338-19
27/2/2024
Ursodeoxycholic Acid
EP 8
Hangzhou Starshine Pharmaceutical Co., Ltd
China
125
VD-32339-19
27/2/2024
Sodium chloride
USP 38
Dominion Salt Limited
New Zealand
126
VD-32340-19
27/2/2024
Piroxicam
USP 38
Jintan Qianyao Pharmaceutical Raw Material Factory
China
127
VD-32341-19
27/2/2024
Paroxetine hydrochloride hemihydrate
USP 38
Zhejiang Huahai Pharmaceutical Co., Ltd
China
128
VD-32342-19
27/2/2024
Alverine citrate
EP 6
Yancheng Jiangzhong Chemicals Co., Ltd
China
129
VD-32343-19
27/2/2024
Dimenhydrinate
BP 2014
S.S. Pharmachem
India
130
VD-32344-19
27/2/2024
Zinc gluconate
USP 38
Shanpar Industries Pvt.Ltd
India
131
GC-313-19
27/2/2024
Chlorpheniramine maleate
USP 35
Supriya Lifescience Ltd
India
132
QLĐB-757-19
27/2/2022
Febuxostat
TCNSX
Ami Lifesciences Pvt. Ltd
India
133
VD-32471-19
27/2/2024
Tadalafil
EP 8.0
ULTRATECH INDIA LIMITED
India
134
VD-32028-19
27/2/2024
Sucralfat
USP 38
Northeast Pharmaceutical Group Co., Ltd
China
135
VD-32029-19
27/2/2024
Telmisartan
EP 8
Verdant Life Sciences pvt. ltd
India
136
VD-32030-19
27/2/2024
Telmisartan
EP 8
Verdant Life Sciences Pvt.Ltd
India
137
QLĐB-759-19
27/2/2022
Levonorgestrel
USP 36
Beijing Zizhu Pharmaceutical Co.Ltd
China