The pharmaceutical manufacturing industry in Vietnam is undergoing a powerful transformation driven by the internationalization of production standards. While WHO-GMP was once the primary objective, EU GMP (European Union Good Manufacturing Practice) has now become the "golden ticket" for pharmaceutical enterprises to elevate their brand positioning and conquer the global market.
In this article, GMPc Vietnam provides an updated list of EU-GMP certified factories in Vietnam as of 2026 and the most optimized consultancy solutions for facility construction.
I. Strategic Importance of EU-GMP Standards
Establishing and maintaining an EU-GMP compliant facility delivers core values that define a company's market standing:
Optimizing Tendering Capability: Meeting EU-GMP standards provides a significant competitive edge when participating in Group 1 and Group 2 drug tenders within the public health system.
International Market Penetration: This serves as a vital "passport" for Vietnamese pharmaceuticals to access the European market and other highly regulated regions worldwide.
Commitment to Uniform Quality: This standard ensures that every manufacturing process achieves maximum precision and safety according to international benchmarks.
However, the roadmap for investment, design, and construction of an EU-GMP compliant plant requires substantial financial resources, the involvement of seasoned experts, and a systematic implementation timeline (typically 24 to 36 months).
II. Updated List of EU-GMP Certified Factories in Vietnam (As of 2026)
Below is the list of pharmaceutical manufacturing enterprises in Vietnam that have achieved EU-GMP certification as of 2026. This group includes facilities inspected and certified directly by EU regulatory authorities (such as those Hungary, Germany, Poland, Bulgaria, etc.).
1. Multi-facility Owners (10 facilities)
- Imexpharm Pharmaceutical Joint Stock Company (03 facilities):
Plant 1 (Branch 3): No. 22, Street 2, VSIP II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong. (Certified by: Hungary).
Vinh Loc High-Tech Antibiotic Plant: Lot B15/I - B16/I, Street 2A, Vinh Loc IP, Binh Hung Hoa B Ward, Binh Tan District, HCMC. (Certified by: Hungary).
Binh Duong High-Tech Plant: No. 21, Street 4, VSIP II, Hoa Phu Ward, Thu Dau Mot City, Binh Duong. (Certified by: Hungary).
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- Stellapharm J.V. Co., Ltd. (02 facilities):
Binh Duong Plant (Branch 1): No. 40 Tu Do Avenue, VSIP, An Phu Ward, Thuan An City, Binh Duong. (Certified by: Germany).
HCMC Plant: K63/1 Nguyen Thi Soc, My Hoa 2 Hamlet, Xuan Thoi Dong, Hoc Mon District, HCMC. (Certified by: Croatia).
- Medochemie (Far East) Co., Ltd. (02 facilities):
VSIP II Plant: No. 40 VSIP II, Street 6, Hoa Phu Ward, Thu Dau Mot City, Binh Duong. (Certified by: Cyprus).
VSIP II-A Plant: No. 10, 12, and 16 VSIP II-A, Street 27, Vinh Tan Ward, Tan Uyen City, Binh Duong. (Certified by: Cyprus).
- Pymepharco Joint Stock Company (02 facilities):
PME I Plant: No. 166-170 Nguyen Hue Street, Ward 7, Tuy Hoa City, Phu Yen. (Certified by: Romania).
- Stada Vietnam Plant: No. 189 Hoang Van Thu, Ward 9, Tuy Hoa City, Phu Yen. (Certified by: Romania).
Hasan - Dermapharm J.V. Co., Ltd. (01 facility):
Plant 2: Lot F, Street 5, Dong An IP, Binh Hoa Ward, Thuan An City, Binh Duong. (Certified by: Poland).
2. Single-facility Owners (09 facilities)
- DHG Pharmaceutical JSC (DHG Pharma): Lot B2-B3, Tan Phu Thanh IP, Chau Thanh A District, Hau Giang. (Certified by: Hungary and Austria).
- United International Pharma Co., Ltd.: No. 16 VSIP II, Street 7, Hoa Phu Ward, Thu Dau Mot City, Binh Duong. (Certified by: Austria).
- OPV Pharmaceutical JSC: No. 27, Street 3A, Bien Hoa II IP, An Bình Ward, Bien Hoa City, Dong Nai. (Certified by: Portugal).
- Danapha Pharmaceutical JSC: No. 253 Dung Si Thanh Khe Street, Thanh Khe Tay Ward, Da Nang. (Certified by: Bulgaria).
- Hai Duong Pharmaceutical Medical Material JSC (HDPHARMA): Land lot 307, Cam Thuong Industrial Cluster, Cam Thuong Ward, Hai Duong City. (Certified by: Bulgaria).
- SaVi Pharmaceutical JSC (SAVIPHARM): Lot Z01-02-03a, Tan Thuan EPZ, Tan Thuan Dong Ward, District 7, HCMC. (Certified by: Hungary).
- Boston Vietnam Pharmaceutical JSC: Building 2, No. 43, Street 8, VSIP, Binh Hoa Ward, Thuan An City, Binh Duong. (Certified by: Portugal).
- Tenamyd Pharmaceutical JSC: Lot Y01-02A, Tan Thuan Street, Tan Thuan EPZ, District 7, HCMC. (Certified by: Bulgaria).
- Fremed Pharmaceutical JSC: Lot E9-3a, Street 1, Hiep Phuoc IP, Nha Be District, HCMC. (Certified by: Portugal).
3. Equivalent Standards Group (JAPAN-GMP, TGA-GMP)
Japan-GMP (Japan) and TGA-GMP (Australia) standards are recognized by the Vietnamese Ministry of Health as equivalent to EU-GMP for Group 1 drug procurement bidding.
- Rohto-Mentholatum (Vietnam) Co., Ltd.: No. 16 VSIP, Street 5, Thuan An, Binh Duong. (Standard: Japan-GMP).
- Sanofi Vietnam JSC: Lot I-8-2, High-Tech Park, Thu Duc City, HCMC. (Standard: TGA-GMP).
- Nippon Chemiphar Vietnam Co., Ltd.: No. 76 Doc Lap Avenue, VSIP, Thuan An, Binh Duong. (Standard: Japan-GMP).
- Mekophar Co., Ltd.: Lot I-9-5, High-Tech Park, Thu Duc City, HCMC. (Standard: Japan-GMP).
- Otsuka Vietnam Pharmaceutical JSC: Lot 512, Long Binh IP, Bien Hoa, Dong Nai. (Standard: Japan-GMP).
III. GMPc Vietnam - Leading EU-GMP Facility Consultancy
With 15 years of formation and development, GMPc Vietnam is proud to be a premier consultancy, partnering in the success of over 300 factory projects nationwide. We hold over 80% market share of pharmaceutical and cosmetic plant consultancy projects in Vietnam for the period 2011 - 2026.
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Why choose GMPc Vietnam for your EU-GMP project?
- Proven Field Experience: Successfully consulted for major brands such as DHG Pharma, Mediplantex, Cuu Long Pharmaceutical, etc.
- Comprehensive Solutions: From conceptual and detailed design, construction supervision, and equipment installation to personnel training and certification dossier preparation.
- Cost & Time Optimization: Our team of experts possesses deep knowledge of Ministry of Health regulations and EMA (European) standards, helping businesses avoid errors that waste resources.
Further Reading:
Experiences in Building and Maintaining High-Standard Pharmaceutical Plants
List of Pharmaceutical Plant Projects Consulted by GMPc Vietnam
