gmpc profile 2015

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GMPc Vietnam JSC Consulting for Investment- Construction- Operating GMP Plant

Head Office : Blue office – No 4 – BT1 Bui Xuan Phai Str, My Dinh 2, Tu Liem, Ha Noi Tel/Fax : 043.994.5757 / 043.787.2243 HCM Office : 196/48, Cong Hoa Street, 12 Ward, Tan Binh District, HCM city

Tel/Fax : 08.3881.7383 Hotline : 0982.866.668 Email : [email protected]; Website: www.gmp.com.vn

COMPANY PROFILE

GMPc VIET NAM JOINT STOCK COMPANY

Ha Noi – 2015

mailto:[email protected]

http://www.gmp.com.vn/

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CONTENTS

Part 1: Company information and Consulting Services

- General information

- Consulting Services

Part 2: Experience

- Consulting Experience & Project

- Human resource

Part 3: Annex

- Annex 01: Typical GMP Facilities Project

- Annex 02: Typical Consulting Contracts

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Part 1

COMPANY INFORMATION & CONSULTING SERVICES

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I – INFORMATION

1. Legal information

Full name : GMPc VIET NAM JOINT STOCK COMPANY

Short name : GMPc JSC;

Legal representative : Mrs. Tran Thi Ngoc Ha – General Director

Head Office : Blue office – No 4 – BT1 Bui Xuan Phai Str, My

Dinh 2, Tu Liem, Ha Noi

Tel/Fax : 04.3994.5757/04.3787.2243

HCM Office : 196/48, Cong Hoa Street, 12 Ward, Tan Binh District, HCM city

Tel/Fax : 08.3811.7383

Hotline : 0982.866.668

Email : [email protected]

Website : www.gmp.com.vn

Types of company : Joint Stock Company 2. Established:

Date established: May 25th 2011 Codes of License Business: 0105328140 (by Ha Noi Authority for Planning and

Investement granted on May 25th 2011) Legal capital: 5,000,000,000 Vnd (Five billions VND)

3. Highlights and Positive differences:

Vision: Recognized as the pioneering consultant in Consulting for Investment -

Construction – Operating GMP Facilities in compliance with the

mailto:[email protected]

http://www.gmp.com.vn/

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principles and guidelines of GMP in Viet Nam. Experts works in GMPc have both

practical experience and profound understanding about nature of GMP

Guidelines, with passion and effort to create Innovative – Suitable – Effective

consulting solutions basis on understanding needs and strategies different of each

client

Mission:

Providing innovative consulting services, help for Investment - Construction - Operate of GMP Facilities become Simplify, guaranteed for get GMP certification

with cost savings..

Strategy:

Products/services All of Products/services of GMPc are origined from actual needs, wishes of the

owners who are manufacturing and carring on business products comply with the

principle, GMP, GLP, GSP Guidelines, .… and the creative efforts of GMPc. Each

products / services were created to ensure criteria:

We omitted steps, opinion which are unnecessary and GMP does not

required but still being applied in a mechanical way, does not br ing any

useful value.

We simplify all of the matter on the basis of correct understanding of the

value, principle and guidelines systems GMP to match with the actual

condit ion of Vietnam as well as requirements, provisions of the State

administration.

Creativity, innovation to apply GMP will increase the more useful and

sustainable values for businesses w i t h o u t increasing any cost.

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Human resource Human resources are the core values that make position and difference of GMPc.

One of the most an important strategy of the company is training and developing

workforce through the exchange, external and internal training. Additional

experience and knowledge through exchange forms, sharing of knowledge and

experience, cooperating with team advisor, collaborator, state

management agencies, institutes, universities, especially the factory and business

establishments according to the principles and GPs guidelines.

Company images Honest - Responsible – Creative Consultant.

Slogan

Good Consultant – Expert on Practices

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II. CONSULTING SERVICES Consulting factory Investment – Construction– Operation in compliance

with the principle, guidelines GMP/GLP/GSP (ASEAN, WHO, EU, cGMP …)

and others GPs

1. Project - Feasibility project report Consulting

Investment project consulting (Other name: Feasibility project report,

Technical-economic explanation)

Mission – Target – Result: Systematizing needs, planning, Total

estimations, effect, feasibility,… calculation 2. Technology and Equipment Consulting

Technology and equipment consulting (Manufacturing, testing,

auxiliary systems)

Mission – Target – Result: Based on technical requirements, product specifications, expected output of the project, the consultant and the owner established technology process; A request for technical specifications of the equipment; required suppliers list (at least 03 supliers)… Basic on this, the owner will choose suppliers/ bidders have the best technique and lower cost.

3. Construction and M&E drawings Design

Architecture/structural and M&E drawings design services

Mission – Target – Result: Architectural drawing & Building texture; Design ventilation systems - air conditioning HVAC, electricity, water (RO water, distilled water, wastewater), compressed air systems… suit the producing purpose, demand and comply GMP guidelines.

4. Project management - construction supervision

Project management and construction supervision, equipment installation

supervision services

Mission – Target – Result: Consist of project management: Quality control, progress, safety, cost… Procurement consultants, choosing suppliers/ bidders consultants; construction and manufacturing equipment installation, testing, auxiliary systems… supervision to ensure quality, progress, cost, safety… established IQ (Installation Qualification), OQ (Operation Qualification) PQ (Performance Qualification)

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5. Training and practice guidelines for GMP/GLP/GSP

Training and practice guidelines for GMP/GLP/GSP (HACCP, ISO 17025, ISO

13485,…

)

Mission – Target – Result: GMP/GLP/GSP Guide - Practical Training Services combination between training and practice guidelines, forcuse on practice guidelines factors combined in conjunction with theory (On job training), made by practical experience experts on GMP production facilities to ensure knowledge and practice skills of employees .

6. Evaluation/ re-evaluation GMP/GLP/GSP documentation Establishment

Established GMP/GLP/GSP documents (firstly/ re-evaluation)

Mission – Target – Result: Preparing procedures according to require of state management agencies, GMP/GLP/GSP validation and holding inspection ourselves, overcome before and after the time of the evaluation.

7. Factory management under GMP/GLP/GSP

Manufacture operation management consultant in compliance with

GMP/GLP/GS

P

Mission – Target – Result: Consultant directly charges the management and operation of the manufacturing of factory. Project owners take the time to focus on the issues of market output, input and materials, packaging and other issues.

8. Outsourcing Contract management

Manage and supervision perform manufacturing processing contract

customers with production processing facility

Mission – Target – Result: GMPc on behalf customers perform manufacturing processing contract at processing plant to ensure all of requirements are mentioned contract; quality assurance according to the principles of GMP / GLP / GSP;

9. Outsourcing factory Management

Consulting, rating processed products factory (Before and during process of

outsourcing products)

Mission – Target – Result: Helping customers understand the entire infrastructure, human resource and other conditions of processing production factory, capable of satisfy the requirements of the outsourcing contract,

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comply with the principles of GMP/GLP/GSP. Using this service,

customers

have a comprehensive assessment, completely related aspects such

as:

people, hardware, equipment, quality assurance, quality control, maintenance

... before and during process of outsourcing products. 10. Product formulation Optimization

Optimized of product formulation

Mission – Target – Result: Optimized of product formulation, improve the quality, product forms, with requirements do not increase the production cost of the product.

11. Production Process Optimization

Optimized of Production Process (and testing processes, storage,... related

to production)

Mission – Target – Result: Product quality is assured with reduced production time, waste products, create product rotation process stability. Using this service helps customer increase production efficiency, reduce time, reduce waste, create product cycling stability

12. formula and Production process Transfer

Transfer formula and Production process

Mission – Target – Result: Research, innovation, formulation and processes product development in order to create quality and form products better than. Using this service, customers will have the new formula and manufacturing process with desired standard products

13. product standards Drafting

Drafting product standards

Mission – Target – Result: Drafting product standards complies with the

regulation and advantages of production, ensure efficient business. 14. Product registration dossier

Completely Product registration dossier

Mission – Target – Result: Consulting to complete product registration

dossier from begining until it is granted a new registration number. 15 Testing labs establishment under GLP and ISO 17025

Established testing labs complies with GLP and ISO 17025

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Mission – Target – Result: Established testing labs complies with

the

principles GLP and ISO 17025 standard, including including entire issues related to infrastructure (design, construction, equipment, ...) and Documentation, Human Resources, ...

16. GSP, GDP, GPP,.. Establishment

Setting up storage, distribution systems, pharmacy complies with the

principles GSP, GDP, GPP, ..

Mission – Target – Result: Setting up storage, distribution system, pharmacy, including entire issues related to infrastructure (design, construction, equipment, ...) and Documentation, Human Resources, ...

17. WHO – GACP consultancy

Good Agricultural and Collection Practices consultants in compliance with

GACP -

WHO

Mission – Target – Result: Consulting – transfer - supply seedling - Cultivation technique, Collection, process pharmaceutical in compliance with Good Agricultural and Collection Practices (WHO GACP).

18. Training GMP, GLP, GPs, ISO, HACCP according to toppics

Professional training GMP, GLP, GSP, GDP, ISO 17025, ISO 13485, HACCP,…

Mission – Target – Result: Training Services according to topics or

requirement of customers for Senior Manager, intermediate or all employees.

GMPc Viet Nam Joint Stock Company

http://gmp.com.vn/thiet-lap-kho-bao-quan-gsp/thiet-lap-kho-bao-quan-theo-gsp-1041532.html

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Part 2

CAPACITY AND EXPERIENCE PROFILE

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I. EXPERIENCED CONSULTANT- IMPLEMENTED PROJECTS

Established on 25th May 2011, GMPc has performed the GMP plant projects in all fields: Pharmaceutical manufacturing, pharmaceutical packaging, aquatic animal veterinary medicine, cosmetics, medical equipment,… Details of WHO GMP/GLP/ GSP Projects under the following categories (updated to August, 2015): Consulting contract list of: Investment – Technology – Design – Project managerment and training – Guiding to plan review documentation of GMP/GLP/GSP in period of 2011-2015

No

Contents

Implementation

status

The ower (Location)

Time of signing

A Medical Equipment Factory Project suited the GMP principle

1.

- Consulting & training, practice complete GMP audit documentation for American Vietnamese Biotech Incorporation

Finished

American Vietnamese Biotech Incorporation (HCMC)

July, 2013

2.

- Consulting establishes investment project

- Medical Equipment Factory UHC suited to GMP guidelineMedical Equipment Factory

Finished

United Healthcare JSC (HCMC)

June, 2013

B

Packaging Factory project suite to GMP guideline Pharmaceutical packaging

3.

- Consulting overall plan manufactory, testing areas & sync ancillary items GMP packaging standards

- Consulting manufactory technology drawing design, testing areas…

- Establish to estimated investment cost

Finished

Duy Tan plastics Corp. (HCMC)

November, 2013

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No Contents

Implementation

status

The ower (Location)

Time of signing

4.

- Consultant manufacturing technology drawing design, testing area…

- Design & drafting estimated M&E systems

- Consulting construction supervision & installation of factory equipment.

Finished

Hong Hai Dang plastics company (Bình Minh town – Vinh Long Province)

May, 2013

5.



- Management and construction

supervision Projects

- Consulting & training, practice,

complete GMP audit

documentation

On going

Phuc Duc Company (Cai Rang District – Can Tho City)

May, 2013

6. - Consultant manufacturing technology drawing design, testing area…


Finished Huphumeglass JSC (8 District – HCMC)

May, 2013

7.


- Design & drafting estimated

M&E systems, estimating the

value of investment

- Consulting & training practice of GMP audit documentation

Finished

Truong Song Long An JSC.; (Ben luc District – Long An Province)

March, 2013

8.

- Qualification, complete drawing design and drafting estimated M&E


complete GMP audit

documentation

On going

Agricultural Packaging Print JSC (Thanh tri District – HNC)

March, 2013

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No

Contents Implementation status

The ower (Location)

Time of signing

9




complete GMP audit

documentation

Finished

Liksin Corporation (Duc Hoa District – Long An)

February, 2013

10.



- Managerment, Contruction supervision & installation of equipment M&E

- Consulting & training,

practice, complete GMP audit

documentation

On going

Cuong Phat Plastic Co. Ltd

( Binh Tan District – HCMC)

February, 2013

11.



- Projectmanagement,constructio

n supervision projects

- Consulting & training, practice, complete GMP audit documentation

Finished

Gia Phat Co., LTD (Hoc Mon District - HCMC)

February, 2013

12.



- Project management,

construction supervision

projects & installation of factory

equipment.


Finished

Dong Au Packaging Company (Que Vo District – Bac Ninh Province)

January, 2013

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No

Contents Implemention status

The ower (Location)

Time of signing

13.

- Project management

consultant,construction supervision projects & installation of factory equipment.


complete GMP audit

documentation

Finished

Tan Thanh Packaging JSC., (Tan Phu District - HCMC)

September 2012

C. Cosmetics Factory Project (GMP ASEAN) – Functional Foods

14

- Improvement of Construction

Consulting

- M& E Design Advicing

- ASEAN GMP/GLP/GSP

documentation Completing

On going

Thavon JSC.

(Da Lat)

March,

2015

15

- Technology consulting - Design building improvement

and M&E system - Advice to choose tender and

supervisor of construction and equipment installation

On going

Vitadary JSC

August,

2014

16

- Design consulting - Project Management and

Supervision - Training and Guiding practices of

GMP audit documentation

On going

Giang Dien

Cosmetics JSC

Novembe

r, 2014

17.

- Adjust design drawings

- Training – practice guidelines GMP

- Guidelines for drafting

documents, documents of the

factory, in order to achieve the

objective gain the certificate of

GMP-HACCP

Finished

Nutifood JSC (BinhDuong

Province)

October, 2013

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No

Contents

Implemention status

The ower (Location)

Time of signing

18.

- Consulting, contruction design,

M&E systems - Consulting & training, practice,

complete GMP audit

documentation

Finished

Familiar Cosmetic Company (Tan Binh District – HCMC)

December, 2012

19.

- Consulting transfer milk powder

products formula

Finished

Dai Hung Tinh Company ( 9 District – HCMC)

June, 2012

20.

- Design M&E systems,

manufactory functional food and cosmetics Gia Nguyen (GMP – WHO)

Finished

Sagen Company (Phu Nhuan Distric, .HCMC)

June, 2011

21

- GMP ASEAN Cosmatics

manufacture Factory

On going

E.B.C Giang

Dien

Cosmetics Co

Ltd.

June, 2015

22

- Construction Design Completing

for the factory of Functional

foods , additional foods

Manufacturing

On going

Medibest JSC

(Thanh Xuan, Ha noi)

May, 2015

23

- Consult to improve AHU

according to clean room

standards for Milk manufacture

factory

On going

Eneright Nutrion and Foods Co Ltd

(Vinh Phuc )

July, 2015

D

Veterinary medicine factory project - aquatic products certification GMP

WHO

24.

- Consulting & training, practice,n

complete GMP audit

documentation

On going

Nam Dung Veterinary Medicine Company (Van Lam District – Hung yen)

December, 2013

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No

Contents

Implemention status

The ower (Location)

Time of signing

25

Consulting factory

production of veterinary

drugs under GMP - WHO

On going

Greenlab Việt Nam Company

(Gia Lam District –HNC)

December, 2013

26.

- Support design M&E - Supervision management M&E - Guidelines established GMP

audit documentation for powdered drug chains

- Training QA, QC, production

and preparation of documents

the reevaluation of GMP

production for oral & injection

drugs chains

Finished

Hung Nguyen Company (My Hao District- Hung Yen Province)

Setemper 2013

27


consultant,construction supervision projects & installation of factory equipment.


complete GMP audit

documentation preparation of

documents the reevaluation of

GMP production for oral &

injection drugs chains

Finished December 20113

Can Tho Veterinary Medicine Company (Ninh Kieu District – Can Tho Province)

June, 2013

28.

- Project management consultant,

construction supervision projects &installation of factory equipment.

- Consulting & training, practice, complete dossier GMP audit documentation

Finished December

2013

A Chau Veterinary Medicine Company (Cai Răng District – Can Tho Province)

April, 2013

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No

Contents

Implemention status

The ower (Location)

Time of signing

29

- Consulting overall, design – drafting estimated of Contruction and M&E systems


construction supervision &

installation of factory

equipment.


Finished Certified GMP on Septemper, 2013

Cai Lay

Veterinary

Medicine

Company(Cai

Lay District –

Tien Giang

Province)

October, 2012

30.

- Consulting product transfer

formula of aquatic veterinary

medicine.

Finished

SanDo Company (12 District– TP.HCM)

May, 2012

31

- Consult completely hardware

design

(construction- equipment);


complete dossier GMP

evaluation

Finished

Kyoto Biken Hà nội Laboratories Company (Japan) (Thang Long II Industrial Park- Hung Yen Province)

May, 2012

32.


construction supervision & installation of factory equipment.


complete GMP audit

documentation

Finished Certified GMP on March 2013

1/5 Veterinary Medicine Company (Ninh Kieu District- Can Tho City)

June ,2012

33 .


construction supervision & installation of factory equipment.


Finished Certified GMP on March 2013

UV Việt Nam Company (Binh Tan District - HCMC)

February, 2012

Page


No

Contents

Implementation status

The ower (Location)

Time of signing

34


complete GMP audit

documentation

Finished

Viet Tho Veterinary Medicine Company (Trang Bom District -Đong Nai Province)

February, 2012

35



consultant, construction

supervision & installation of

factory equipment.

Finished Certified GMP on January 2013

Greenlab Veterinary Medicine Company (Gia Lam District - HaNoi City)

January, 2012

36




installation of technology

equipment.


Finished Certified GMP on December 2013

Hung Nguyen Veterinary Medicine Company (My Hao District- Hung Yen Province)

June ,2011

37.


construction supervision & installation of technology equipment.


Finished Certified GMP on August 2011

A Chau Veterinary Medicine Company (Cai Rang District Can Tho City)

June ,2011

38




equipment.

- Consulting & training of practice and completation of GMP audit documentation

Finished Certified GMP on August 2013

Maphavet Veterinary Medicine Company (Pho Yen District – Thai Nguyen Province)

May, 2011

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No

Contents


The ower (Location)

Time of signing

E

Pharmaceutical Factory Project (GMP WHO), Laboratory GLP, Storage GSP

39

- Consulting to design

improvement M&E system

- Training GMP/GLP/GSP

On going

Di Hao JSC

(Long An)

April, 2015

40

- Consulting to set Investment

project

- Consulting technology and

designing M&E of factory

- Consulting management of

project

- Training and drafting WHO

GMP documentation

T

On going

Hoang Lien

Herbal JSC

(Phu Tho

Province)

April, 2015

41

- Consulting technology

- Training and guiding practice

of GMP/GLP/GSP in

manufacturing excipients

Finished

Phu My

Alcohol and

Starch JSC

(Hoa Binh

province)

November,

2014

42

.

- Consuting to plan Investment

Project




equipment.


Finished

Vietnam

Herbal JSC

(Ninh Hiep,

Hanoi)

September,

2014

Page


No

Contents


The ower (Location)

Time of signing

43

- Consulting contruction and M&E drawing design

- Consultation of bidding - Project management

consultant,construction & M&E

supervision.

- Consulting & training, prepare documentation GSP audit

On going

VCP Pharmaceutical (Sóc sơn, Hà Nội)

September, 2014

44

- Consulting M&E and

construction - Advice to choose equipment

and technology

De

Finished

408 Manufacture firm, Dong Tam snake farm,

(Tien Giang)

April, 2014

45

- Consulting M&E and construction

- Advice to choose equipment and technology


Finished

408 Manufacture firm, Dong Tam snake farm,

(Tien Giang)

April,2014

46



consultant, construction

supervision & installation of

factory equipment.


On going

BioSpring JSC

(Hoa Lac, Ha Noi)

March,

2014

47

- Consulting contruction and M&E drawing design

- Consultation of bidding - Project management

consultant, construction & M&E

supervision.

- Consulting & training, prepare GSP audit documentation

Finished

Hapharco

(Tan Binh,

HCMC)

September,

2013

Page


No

Contents


The ower (Location)

Time of signing

48..

- Project management consultant

of construction supervision & installation of equipment.

On going

Que Lam Pharmaceutical Company

( Gia Lâm District -HNC)

December, 2012

49.

- Project management consultant,

construction manufactory

pharmaceutical

Finished

Hau Giang Pharmaceutical Company (Ninh Kieu District- Can Tho City)

September, 2011

50

- Consult to complete Concept

Design of WHO GMP factory

On going

Kajima

Overseas Asia

Pte Ltd

(Binh Duong

Province)

July, 2015

51

- Consult to improve warehouse

- Plan Investment costs

- Supervise equipment installation

Finished

Ninh Hiep

Herbal JSC

(Gia Lam,

Hanoi)

June, 2015

GMPc Viet Nam Joint Stock Company

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II. HUMAN RESOURCE

1. Introduce to consultants

Human Resource are core strengths to create GMPc and the most positive

difference GMPc in the consulting company of Investment - Build - Operate GMP

factory in Vietnam. That human resource has extensive experience in the direct

management and construction project certificated WHO-GMP in Vietnam such as

ICA , BVPharma , Glomed , Savipharm , Lili of France , Pharmacy Hau Giang

... Middle management team is trained abroad and in multinational

companies in Vietnam such as: Unilever Vietnam , Panasonic (Japan), LG (Korea

) ... with the expertly manner and process management. Due to the fact that

building factory project is certified GMP – WHO is a special project, besides

normally knowledge and experience of implementing investment projects on the

construction, we need understanding and applying accordingly the principles of

GMP - WHO guidelines for the construction of infrastructure, and with that

ordinate well with department of documents, ensuring the synchronization

between basic material and quality systems of the plant.

2. Consultants list

No

Full name

Professional

Year of Birth Experiences

(years)

1.

Dao Xuan Huong

Engineer

1976

14 years

2.

Hoang Xuan Quang

Pharmacists

1972

16 years

3.

Do Quang Huy

Engineer

1981

10 years

4.

Nguyen The Luong

Dr.

1979

11 years

5.

Bui Manh Hung

Dr.

1987

04 years

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No

Full name

Professional

Year of Birth Experiences

(years)

6.

Pham Van Thoai

Dr.

1979

12 years

7.

Trinh Minh Thang

Pharmacists

1985

5 years

8.

Vu Dinh Tinh

Engineer

1982

8 years

9.

Truong Quang

Huyen

Engineer

1985

6 years

10.

Le Tuyen Ai

Engineer

1972

17 years

11.

Truong Hong Tuan

Engineer

1970

20 years

12.

Ha Van Hung

Engineer

1981

10 years

13.

Nguyen The Giang

Engineer

1988

4 years

14.

Nguyen Thanh Thai

Engineer

1976

14 years

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Part 3

ANNEX

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Annex 01: Typical GMP factory project Hung Nguyen Veterinary Medicine Factory – Hung Yen Province

Gia Nguyen Functional Foods Factory – Bac Ninh Province

Page


Hau Giang Pharmaceutical Factory – Can Tho Province

UV Việt Nam Veterinary Medicine Factory – HCMC

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Kyoto Biken HaNoi Laboratories Factory (Japan) – Hung Yen Province

Veterco Factory – Can Tho Province

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Mekovet Factory - Tien Giang Province

Hoang Lien Herbal Factory

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Biospring Factory

Nippon Factory - Binh Duong Province

gmpc profile 2015

Health & Medicine