Công văn 23163/QLD-ĐK năm 2018 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 do Cục Quản lý Dược ban hành

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

VD-24229-16

23/03/2021

Cefotaxime sodium sterile

USP 38

Reyoung Pharmaceutical Co., Ltd

China

2

VD-21661-14

19/09/2019

Amoxicillin trihydrate

BP 2015

DSM Sinochem Pharmaceuticals India Pvt., Ltd

India

Potassium clavulanate and microcrystalline

(Potassium clavulanate with avicel) (1:1)

EP 8.0

Sinopharm Weiqida Pharmaceutical Co., Ltd

China

4

VD-21658-14

19/09/2019

Imipenem and Cilastatin (1:1) for injection sterile

USP 38

Aurobindo Pharma Ltd

India

5

VD-25105-16

05/09/2021

Phenylephrine hydrochloride

USP 34

Siegfried PharmaChemikalien Minden GmbH

Germany

6

VD-28809-18

22/02/2023

Phenylephrine hydrochloride

USP 34

Siegfried PharmaChemikalien Minden GmbH

Germany

7

VD-23006-15

09/09/2020

Galantamine hydrobromide

NSX

JUBILANT GENERICS LIMITED

India.

8

VD-29978-18

27/03/2023

Acetaminophen

USP 35

SpecGx LLC

USA

9

QLĐB-731-18

08/10/2021

Famciclovir

USP 39

Hetero Drugs Limited

India

10

QLĐB-732-18

08/10/2021

Famciclovir

USP 39

Hetero Drugs Limited

India

11

VD-21432-14

12/08/2019

Sodium lactate

EP 8.0

Galactic

Belgium

12

VD-24952-16

15/07/2021

L-Isoleucine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

13

VD-24952-16

15/07/2021

L-Lysine hydrochloride

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

14

VD-24952-16

15/07/2021

L-Tryptophan

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

15

VD-24952-16

15/07/2021

L-Threonine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

16

VD-24952-16

15/07/2021

L-Valine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

17

VD-24952-16

15/07/2021

L- Phenylalanine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

18

VD-24952-16

15/07/2021

L- Methionine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

19

VD-24952-16

15/07/2021

L - Leucine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

20

VD-24952-16

15/07/2021

Glycine

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

21

VD-24952-16

15/07/2021

L-Arginine hydrochloride

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

22

VD-24952-16

15/07/2021

L-Histidine hydrochloride monohydrate

EP 8.0

Kyowa Hakko Bio Co., Ltd.

Japan

23

VD-24952-16

15/07/2021

Xylitol

JP XVII

B Food Science Co., Ltd.

Japan

24

VD-1042-06

06/04/2019

Rifampicin

EP8

Sanofi S.p.A

Italia

25

VD-24414-16

23/03/2021

Pyrazinamide

BP 2015

Linaria Chemicals (Thailand) Ltd.

Thailand.

26

VD-24414-16

23/03/2021

Pyrazinamide

BP 2015

Amsal Chem (P) Ltd.

India

27

VD-23353-15

09/09/2020

Desloratadine

In-house

Glenmark Pharmaceuticals Limited

India

28

VD-23361-15

09/09/2020

Perindopril erbumine

EP 7.0

Glenmark Pharmaceuticals Limited

India

29

VD-21769-14

19/09/2019

Perindopril erbumine

EP 7.0

Glenmark Pharmaceuticals Limited

India

30

VD-23990-15

17/12/2020

Perindopril tert-butylamin

EP 7.0

Glenmark Pharmaceuticals Limited

India

31

VD-23984-15

17/12/2020

Venlafaxine hydrochloride

EP 7.0

Cipla Ltd.

India

32

VD-19692-13

12/10/2019

Amlodipine besylate

EP 8.0

Cipla Limited

India

33

VD-26558-17

06/02/2022

Calcium carbonate

EP 8.0

Sudeep Pharma Private Limited

India

34

VD-22013-14

08/12/2019

Vitamin B12 (Cyanocobalamin)

EP 8.2

Sanofi Chimie

France

35

VD-20372-13

27/12/2018

L- Arginine HCl

EP 8.0

Hebei Huayang Biological Technology Co.,Ltd.

China

36

VD-27534-17

22/06/2022

Trimetazidine dihydrochloride

EP 8.0

GVK Biosciences Private Limited

India

37

VD-25029-16

15/07/2021

Trimetazidine dihydrochloride

EP 8.0

GVK Biosciences Private Limited

India

38

VD-23457-15

17/12/2020

Levomepromazine maleate

EP 8.5

Egis Pharmaceuticals PLC.

Hungari

39

VD-23457-15

17/12/2020

Levomepromazine maleate

EP 8.5

ZCL Chemicals limited

India

40

VD-20813-14

12/06/2019

Bisoprolol fumarate

BP 2017

SUPRIYA LIFESCIENCE LTD.

India

41

VD-20813-14

12/06/2019

Hydrochlorothiazide

USP 39

CTX LIFESCIENCE (P) LTD

India

42

VD-20813-14

12/06/2019

Hydrochlorothiazide

USP 39

SUZHOU LIXIN PHARMACEUTICAL CO., LTD

P.R of China

43

VD-20814-14

12/06/2019

Bisoprolol fumarate

BP 2017

SUPRIYA LIFESCIENCE LTD.

India

44

VD-20814-14

12/06/2019

Hydrochlorothiazide

USP 39

CTX LIFESCIENCE (P) LTD

India

45

VD-20814-14

12/06/2019

Hydrochlorothiazide

USP 39

SUZHOU LIXIN PHARMACEUTICAL CO., LTD

P.R of China

46

VD-25265-16

05/09/2021

Pravastatin sodium

EP 8.0

BIOCON LIMITED

India.

47

VD-22438-15

26/05/2020

Ferrous Fumarate

EP 8.0

Dr.Paul Lohmann GmbH KG

Germany

48

VD-22790-15

09/09/2020

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd.

China

49

VD-22791-15

09/09/2020

Paracetamol

BP 2016

Anqiu Lu'an Pharmaceutical Co., Ltd.

China

50

VD-24703-16

15/07/2021

Domperidone maleate

BP 2014

Sri Krishna Pharmaceuticals Ltd.

India

51

VD-26090-17

06/02/2022

Paracetamol

BP 2016

Hebei Jiheng (Group) Pharmaceutical Co., Ltd.

China