Công văn 17259/QLD-ĐK năm 2017 về công bố bổ sung danh mục nguyên liệu làm thuốc được phép nhập khẩu không yêu cầu giấy phép nhập khẩu của thuốc trong nước đã được cấp số đăng ký do Cục Quản lý Dược ban hành

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 lưu hành

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

FORDIA

VD-10856-10

14/08/2018

Công ty TNHH United International Pharma

Metformin HCl

BP 2016

USV Limited

B-1/8, M.I.D.C, Lote-Parshuram Indl. Area, Taluka Khed Ratnagiri 415722 Maharashtra State

India

2

FORDIA

VD-10857-10

14/08/2018

Công ty TNHH United International Pharma

Metformin HCl

BP 2016

USV Limited

B-1/8, M.I.D.C, Lote-Parshuram Indl. Area, Taluka Khed Ratnagiri 415722 Maharashtra State

India

3

KREMIL-S FR

VD-12074-10

14/08/2018

Công ty TNHH United International Pharma

AHMC

(Aluminum hydroxid magnesium carbonate)

TCNSX

SPI Pharma Inc.

40 Cape Henlopen Drive, Lewes, DE 19958

USA

4

KREMIL-S FR

VD-12074-10

14/08/2018

Công ty TNHH United International Pharma

Dicyclomine HCl

USP 30

Olon S.p.a

Via Milano, 186, 2024 Garbagnate Milanes (Ml)

Italy

5

KREMIL-S FR

VD-12074-10

14/08/2018

Công ty TNHH United International Pharma

Simethicone

USP 30

Dow Corning Corporation (Healthcare Ind, Materials Site)

1635 N. Gleaner Road, Hemlock MI 48626

USA

6

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin A palmitate

TC NSX

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4,4334 Sisseln

Switzerland

7

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin D3

TCNSX

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln

Switzerland

8

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Thiamine Hydrochloride

USP30

DSM Nutritional Products GmbH

Emil-Barell-Str. 3 D-79639 Grenzach-Wyhlen

Germany

9

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Riboflavin

USP 30

DSM Nutritional Products France SAS

1 Boulevard d' Alsace, FR-68128 Village-Neuf

France

10

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Niacinamide

USP 30

DSM Nutritional Products Ltd.

39 Jinhui Road, Haizhu District, China 510288-Guangzhou

China

11

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Pyridoxin Hydrochloride

USP 30

BASF (Zhejiang Tianxin Pharmaceutical Co., Ltd.)

No. 215 Fengze Road, Tiantai, Zhejiang 317200

China

12

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Cyanocobalamin

TCNSX

North China Pharmaceutical Victor Co., Ltd.

No.9 Zhaiying North Street, Shijiazhuang, Hebei

China

13

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Ferrous Sulfate

USP30

Dr. Paul Lohmann

Hauptstrasse 2, D-31860 Emmertha

Germany

14

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Ferrous Sulfate

USP 30

Canton Lab

110-A & B GIDC, Makarpura Road, Post Box No. 778, Vadodara, Baroda 390010

India

15

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Calcium Glycerophosphate

BP 2007

Givaudan Lavirotte

56 Rue Paul Cazeneuve, B.P.8344 69356 Lyon Cedex 08

France

16

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Magnesium Gluconate

USP30

Givaudan Lavirotte

56 Rue Paul Cazeneuve, B.P.8344 69356 Lyon Cedex 08

France

17

NUTROPLEX

VD-12075-10

14/08/2018

Công ty TNHH United International Pharma

Lysine HCl

USP 30

Famous Merit

No. 6 Fengling Road, Hefei shuangfeng economic development Zone

China

18

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin A Acetate

TCNSX

BASF

Malmparken 5, DK-2750 Ballerup

Denmark

19

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin A Acetate

TCNSX

DSM Nutritional products

206 Macks Island Drive, Belvidere, New Jesey 07823

USA

20

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin D3

TCNSX

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Stsseln

Switzerland

21

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Sodium Ascorbate

TC NSX

DSM Jiangshan Pharmaceutical (Jiangs u) Co., Ltd.

61 Jiangshan Road, Jingjiang, Jiangsu 2145000

China

22

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Thiamine Mononitrate

TCNSX

Huazhong Pharmaceutical Co., Ltd.

No 71 West Chunuyan Road, Xiangyang City, Hubei Province

China

23

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Riboflavin

USP 30

BASF

57, Oehang 4-gil, Gunsan-si, Jeollabuk-do, Republic of Korea

Korea

24

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Niacinamide

USP 30

DSM Nutritional Products

39 Jinhui Road, Haizhu District, China 510288-Guangzhou

China

25

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Niacinamide

USP 30

DSM Lonza Guangzhou Nansha Ltd.

68, Huangge Dadaobei, Nansha District, China-511 455 Guangzhou, Guangdong Province

China

26

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Pyridoxine Hydrochloride

TCNSX

Zhejiang Tianxin Pharmaceutical Co., Ltd.

No. 215 Fengze Road, Taintai, Zhejiang 317200

China

27

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Calcium Pantothenate

USP 30

BASF SE

Carl-Bosch-Strasse 38, 67056 Ludwigshafen

Germany

28

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Calcium Pantothenate

USP 30

Daichi Fine Chemical Co. Ltd.

530, Chokeiji, Takaoka, Toyama 933-8511

Japan

29

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Folic Acid

USP 30

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln

Switzerland

30

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Copper Sulfate Anhydrous

BP 2007

MERCK KGAA

Frankfurter, Strabe 250, 64293 Darmstadt, (P.O. Box 64271 Darmstadt)

Germany

31

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Ferrous Fumarate

USP 30

Salvi Chemical Industries Ltd

Plot No. E-90,93, 94,95, MIDC, Tarapur-Boisar, Thane, Tarapur - 401506

Taluka: MIDC Tarapur-Boisar, District: Thane-zone4

India

32

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Potassium Iodide

TC NSX

MERCK KGAA

Frankfurter, Strabe 250, 64293 Darmstadt, (P.O. Box 64271 Darmstadt)

Germany

33

NEW OBIMIN

VD-12684-10

14/08/2018

Công ty TNHH United International Pharma

Calcium Lactate Pentahydrate

USP 30

Purac

Arkelsedijk 46, (P.O. Box 21) 4200 AA Gorinchem

Netherlands

34

ODIRON

VD-12685-10

14/08/2018

Công ty TNHH United International Pharma

Pyridoxine Hydrochloride

TC NSX

Zhejiang Tianxin Pharmaceutical Co., Ltd.

No. 215 Fengze Road, Taintai, Zhejiang 317200

China

35

ODIRON

VD-12685-10

14/08/2018

Công ty TNHH United International Pharma

Folic Acid

USP 30

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln

Switzerland

36

ODIRON

VD-12685-10

14/08/2018

Công ty TNHH United International Pharma

Ferrous Sulfate

USP 30

Dr. Paul Lohmann GmbH KG

P.O. Box 1220, D-31857 Emmerthal

Germany

37

ODIRON

VD-12685-10

14/08/2018

Công ty TNHH United International Pharma

Ferrous Sulfate

USP 30

Canton Lab

110-A & B GIDC, Makarpura Road, Post Box No. 778, Vadodara, Baroda 390010

India

38

PREVOST PLUS

VD-12686-10

14/08/2018

Công ty TNHH United International Pharma

Alendronate Sodium Trihydrate

USP30

Cipla Ltd.

Plot No D-27, MIDC, Industrial Area, Kurkumbh, Taluka-Daund, Dist. Pun-413 802, Maharashtra State

India

39

PREVOST PLUS

VD-12686-10

14/08/2018

Công ty TNHH United International Pharma

Vitamin D3

TC NSX

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln

Switzerland

40

ALAXAN FR

VD-13184-10

14/08/2018

Công ty TNHH United International Pharma

Acetaminophen

USP 30

Mallinckrodt Inc.

Raleigh Chemical Plant, 8801 Capital Blvd., Raleigh, North Carolina 27616

USA

41

ALAXAN FR

VD-13184-10

14/08/2018

Công ty TNHH United International Pharma

Ibuprofen

BP 2007

Shasun Chemicals & Drugs Ltd.

Shasun Road, Periyakalapet, Pondicherry 605014

India

42

SOLMUX BRONCHO

VD-13692-10

14/08/2018

Công ty TNHH United International Pharma

Carbocisteine

EP 8.0

PhannaZell (India) Private Limited

Plot No B5/B6 MEPZ, Tambaram Chennai 600045

India

43

PLOGREL

VD-14611-11

14/08/2018

Công ty TNHH United International Pharma

Clopidogrel bisulfate

USP 32

Ind-Swift Laboratories Ltd

Phase-1, Industrial Growth Centre, SIDCO, Samba (J&K)

Philippines

44

ALAXAN

VD-23414-15

09/09/2020

Công ty TNHH United International Pharma

Acetaminophen

USP 35

WEISTAR INDUSTRY LIMITED

8F, Meixin Business Building No. 820 Fenghuang Road, Huzhou Zhejiang

China

45

ALAXAN

VD-23414-15

09/09/2020

Công ty TNHH United International Pharma

Ibuprofen

EP 8.0

ALBEMARLE

725 Cannon Bridge Road Orangeburg, South Carolina

USA

46

ATUSSIN

VD-23415-15

09/09/2020

Công ty TNHH United International Pharma

Dextromethorphan HBr

USP 34

Dr. Reddy's Laboratories Ltd.

8-2-337, Road No 3,Banjara Hills, Hyderabad - 500034, Andhra Pradesh

India

47

ATUSSIN

VD-23415-15

09/09/2020

Công ty TNHH United International Pharma

Chlorphenriamine Maleate

BP 2010

Supriya Lifescience Ltd.

A 5/2, Lote Parshuram Industrial Area, M.I.D.C, Tal. - Khed, Dist. 415722, Maharashatra

India

48

ATUSSIN

VD-23415-15

09/09/2020

Công ty TNHH United International Pharma

Ammonium Chloride

USP 34

Macron Avantor (Mallinckrodt Baker, Inc)

222 Red school lane - Phillipsburg, NJ 08865

USA

49

ATUSSIN

VD-23415-15

09/09/2020

Công ty TNHH United International Pharma

Trisodium Citrate Dihydrate

USP 34

Jungbunzlauer Austria AG

Schwarxenbergplatz 16, AT - 1011 Wien

Austria

50

ATUSSIN

VD-23415-15

09/09/2020

Công ty TNHH United International Pharma

Guaifenesin

BP 2010

Granules India Limited

15A/1, Phase III, I.D.A. Jeedimetla, Hydarabad - 500 055

India

51

HYDRITE COCONUT TABLETS

VD-23416-15

09/09/2020

Công ty TNHH United International Pharma

Dextrose Anhydrous

USP 34

Hebei Shengxue Glucose

Shengxue Rd, Luancheng County, Shijiazhuang City, Hebei Prov.

China

52

HYDRITE COCONUT TABLETS

VD-23416-15

09/09/2020

Công ty TNHH United International Pharma

Trisodium Citrate Dihydrate

USP 34

Jungbunzlauer Austria AG

Schwarzenbergplaz 16, AT-1010 Wien

Austria

53

HYDRITE COCONUT TABLETS

VD-23416-15

09/09/2020

Công ty TNHH United International Pharma

Sodium Chloride

USP 34

Dominion Salts

Tetara Street, Mount Maunganui South,

New Zealand

54

HYDRITE COCONUT TABLETS

VD-23416-15

09/09/2020

Công ty TNHH United International Pharma

Potassium Chloride

USP 34

Macron Avantor (Malinkrodt Baker SDN DHD (32257-W))

A-1201-2, 12^th floor, Kelana Brem Towerl, Jalan SS7/15 (Jalan stadium), Kelana Jaya, 47301 Petaling Jaya, Selangor D.E.

P.O Box 6600, Kg. Tunku, 47369 Peataling Jaya, Selangor Darul Ehsan

USA (Malaysia)

55

HYVAL

VD-23417-15

09/09/2020

Công ty TNHH United International Pharma

Valsartan

USP 34

Smilax Laboratories Limited

Corp. Office: #6/3/1090, TSR Towers 4th Floor (B-block), Raibhavan Road, Somajiguda, Hyderabad - 500082, A.P.

India

56

HYVAL

VD-23418-15

09/09/2020

Công ty TNHH United International Pharma

Valsartan

USP 34

Smilax Laboratories Limited

Corp. Office: #6/3/1090, TSR Towers

4th Floor (B-block), Raibhavan Road, Somajiguda, Hyderabad - 500082. A.P.

India

57

KREMIL-S EXTRA STRENGTH

VD-23419-15

09/09/2020

Công ty TNHH United International Pharma

Simethicone

USP 35

DOW CORNING

8625 S. Inkster road Taylor MI 48180

USA

58

MAXEDO

VD-23420-15

09/09/2020

Công ty TNHH United International Pharma

Acetaminophen

USP 35

Zhejiang Kangle Pharmaceutical Co., Ltd

5/F KangLe Building, No. 112 MaAnChi Road (West), Wenzhou, Zhejiang

China

59

ATUSSIN

VD-24046-15

17/12/2020

Công ty TNHH United International Pharma

Dextromethorphan HBr

USP 34

Dr. Reddy's Laboratories Ltd.

8-2-337, Road No 3, Banjara Hills, Hyderabad - 500034, Andhra Pradesh

India

60

ATUSSIN

VD-24046-15

17/12/2020

Công ty TNHH United International Pharma

Chlorpheniramine

Maleate

BP 2010

Supriya Lifescience Ltd.

A 5/2, Lote Parshuram Industrial Area, M.I.D.C, Tal. - Khed, Dist. 415722, Maharashatra

India

61

ATUSSIN

VD-24046-15

17/12/2020

Công ty TNHH United International Pharma

Ammonium Chloride

USP 34

Macron Avantor (Mallinckrodt Baker, Inc)

222 Red school lane - Phillipsburg, NJ 08865

USA

62

ATUSSIN

VD-24046-15

17/12/2020

Công ty TNHH United International Pharma

Trisodium Citrate Dihydrate

USP 34

Jungbunzlauer Austria AG

Schwarxenbergplatz 16, AT - 1011 Wien

Austria

63

ATUSSIN

VD-24046-15

17/12/2020

Công ty TNHH United International Pharma

Guaifenesin

BP 2010

Granules India Limited

15A/1, Phase III, I.D.A. Jeedimetla, Hydarabad - 500 055

India

64

HYDRITE

VD-24047-15

17/12/2020

Công ty TNHH United International Pharma

Dextrose Anhydrous

USP35

Hebei Shengxue Glucose

Shengxue Rd, Luancheng County, Shijiazhuang City, Hebei Prov.

China

65

HYDRITE

VD-24047-15

17/12/2020

Công ty TNHH United International Pharma

Sodium Bicarbonate

BP 2010

Penrice Soda Products Pty. Ltd.

A.C.C 008 206 942 A.B.N 62 008 206 942 Solvay Road, Osbome, South Australia

Australia

66

HYDRITE

VD-24047-15

17/12/2020

Công ty TNHH United International Pharma

Sodium Chloride

USP 34

Dominion Salts

Tetara Street, Mount Maunganui South

New Zealand

67

HYDRITE

VD-24047-15

17/12/2020

Công ty TNHH United International Pharma

Potassium Chloride

USP 34

Macron Avantor (Malinkrodt Baker SDN DHD (32257- W))

A-1201-2,12^th floor, Kelana Brem Towerl, Jalan SS7/15 (Jalan Stadium), Kelana Jaya, 47301 Petaling Jaya, Selangor D.E.

P.O Box 6600, Kg. Tunku, 47369 Peataling Jaya, Selangor Darul Ehsan

USA (Malaysia)

68

MAXEDO

VD-24656-16

23/03/2021

Công ty TNHH United International Pharma

Acetaminophen

USP 35

Zhejiang Kangle Pharmaceutical Co., Ltd

5/F KangLe Building, No. 112 MaAnChi Road (West), Wenzhou, Zhejiang

China

69

Exulten

VD-26628-17

06/02/2022

Công ty TNHH United International Pharma

Sertraline hydrochloride

USP 36

Hetero Drugs Limited

S-Nos 213, 214, and 255, Bonthapally Village, Jinnaram Mandal, Madak Distric, Andhra Pradesh

India

70

Maxedo

VD-26629-17

06/02/2022

Công ty TNHH United International Pharma

Acetaminophen (Paracetamol)

USP 35

Zhejiang Kangle Pharmaceutical Co., Ltd.

208 Qujiang Road, Economic Technique Develop Zone, Wenzhou, Zhejing, China

China

71

FERLIN

VD-7196-09

14/08/2018

Công ty TNHH United International Pharma

Thiamine Hydrochloride

USP 30

DSM Nutritional Products GmbH

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

Germany

72

FERLIN

VD-7196-09

14/08/2018

Công ty TNHH United International Pharma

Pyridoxine Hydrochloride

USP 30

BASF (Zhejiang Tianxin Pharmaceutical Co., Ltd.)

No. 215 Fengze Road, Tiantai, Zhejiang 317200

China

73

FERLIN

VD-7196-09

14/08/2018

CôngtyTNHH United International Pharma

Cyanocobalamin

USP 30

North China Pharma

No.9 Zhaiying North Street, Shijiazhuang, Hebei

China

74

FERLIN

VD-7196-09

14/08/2018

Công ty TNHH United International Pharma

Folic Acid

USP30

DSM Nutritional Products Ltd.

Zweigniederlassung Werk Sisseln, Hauptstrasse 4, 4334 Sisseln

Switzerland

75

FERLIN

VD-7196-09

14/08/2018

Công ty TNHH United International Pharma

Ferrous Sulfate

USP 30

Dr. Paul Lohmann GmbH KG

Hauptstrasse 2, D-31860 Emmerthal

Germany