EU-GMP “first generic” antibiotics manufactured in Vietnam mark a strategic upgrade in the domestic pharmaceutical value chain.
EU-GMP–certified first generic medicines: Unlocking sustainable growth for Vietnam’s pharmaceutical industry
In the final days of 2025, a noteworthy milestone was recorded as Imexpharm Corporation officially launched its first EU-GMP–certified “first generic” antibiotic manufactured in Vietnam. This next-generation antibiotic represents a significant step forward in enhancing the value chain and competitive capabilities of the domestic pharmaceutical industry.
By definition, a first generic is the first generic version of an originator drug, typically introduced shortly after patent expiration. It provides physicians and patients with additional treatment options at substantially lower costs while maintaining efficacy and safety—particularly when manufactured in compliance with EU-GMP standards.
From a market perspective, this milestone signals Vietnam’s pharmaceutical industry accelerating its transition toward a growth model driven by quality, technological advancement, and depth of investment, rather than relying primarily on volume-based expansion as in previous stages.
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EU-GMP: A Gold Standard of Quality Assurance
Established in 1977, Imexpharm early on identified quality as the foundation of every strategic decision and operational commitment. As the first company in Vietnam to own a Non-Beta Lactam plant certified to GMP-ASEAN standards in 1997, Imexpharm continued investing in EU-GMP–certified manufacturing facilities starting in 2014. By Q4 2016, the Company became the first Vietnamese pharmaceutical enterprise to simultaneously operate three EU-GMP–certified production lines.
To date, Imexpharm possesses the largest number of EU-GMP–certified production lines among domestic pharmaceutical companies, with 12 lines across its IMP2, IMP3, and IMP4 manufacturing complexes.
Meeting the stringent requirements of EU-GMP enables the Company to master the production of technologically complex formulations such as multi-dose antibiotics, injectable drugs, and lyophilized powder for injection—segments that previously depended heavily on imported supply. Through this, Imexpharm continues to strengthen the role of domestic manufacturers within the high-quality pharmaceutical supply chain.
According to industry experts, EU-GMP represents one of the most rigorously audited regulatory standards, subject to periodic reassessment by European regulatory authorities to ensure consistent and continuous quality compliance. Throughout the manufacturing process, raw material selection is strictly based on quality criteria and supplier compliance, ensuring adherence to both WHO-GMP and EU-GMP requirements. All production processes and data are tightly and continuously controlled, forming a transparent and robust foundation for product quality assurance.
R&D and International Partnerships – Long-Term Growth Drivers
To enhance its capability in producing high-tech pharmaceuticals under EU-GMP standards, Imexpharm has strengthened partnerships with leading global pharmaceutical groups such as Sandoz, Sanofi-Aventis, Pharmascience, and Genuone Sciences Inc.
Recently, the share transfer transaction between SK Group and Livzon—an established pharmaceutical and API group with a diversified portfolio ranging from finished pharmaceuticals and APIs to biologics—has been viewed by industry observers as opening new opportunities for Imexpharm in technology transfer and access to regionally leading, internationally competitive pharmaceutical manufacturing expertise.
As science, technology, and data increasingly drive pharmaceutical R&D at a rapid pace, Imexpharm’s expanded international collaboration and technology transfer initiatives are seen as promising prospects, enabling access to advanced technologies and diversified product portfolios. This represents a sustainable growth model that only a limited number of domestic pharmaceutical enterprises have sufficient resources to pursue.
Business Performance Reflecting Strategic Depth
With its deep investment strategy in EU-GMP manufacturing capabilities and international collaboration, Imexpharm has recorded consistent positive growth over recent years. During the 2020–2024 period, the Company achieved a compound annual growth rate (CAGR) of 15.3% in total revenue.
By the end of 2025, Imexpharm’s gross revenue reached VND 2,914 billion, up 16.0% year-on-year and exceeding the domestic pharmaceutical industry’s average growth rate of 9% (based on industry data as of Q3 2025). Net revenue amounted to VND 2,441 billion, representing a 10.7% increase, with balanced contributions from both OTC and ETC channels.
The ETC channel grew by 11.8%, reflecting increasing demand for EU-GMP–certified products and a shift toward higher-value medicines. Meanwhile, the OTC channel recorded 18.3% growth amid a gradual recovery of the retail pharmaceutical market. Revenue from modern pharmacy chains rose significantly, contributing to broader market coverage and strengthening Imexpharm’s brand positioning.
Gross profit margin improved to 41.0% in 2025, supported by effective cost control, optimized production planning, and enhanced operational efficiency across manufacturing facilities.
Sharing the Company’s strategic direction, People’s Physician and Pharmacist Tran Thi Dao, Chief Executive Officer of Imexpharm, stated: “As a pioneer in the industry, we remain committed to building a solid growth foundation based on stringent quality standards, responsible innovation, and a long-term value commitment to all stakeholders.”
Alongside its domestic market expansion, Imexpharm continues to strengthen its international presence, with 28 marketing authorizations in Europe for 11 products, gradually expanding its footprint to more than 40 countries and territories worldwide.