Inside Imexpharm’s EU-GMP–certified pharmaceutical manufacturing plant. Photo: Imexpharm

In the final days of 2025, Vietnam’s pharmaceutical sector marked a significant milestone as Imexpharm Corporation introduced its first “first generic” antibiotic – a next-generation product manufactured in compliance with EU-GMP standards.

First generic drugs are the earliest generic versions of originator medicines, typically entering the market within the initial years following patent expiry. Their introduction expands treatment options for physicians and patients alike, offering substantially lower costs while maintaining stringent standards of efficacy and safety.

This development signals an accelerating shift within Vietnam’s pharmaceutical industry towards a growth model driven by quality, advanced technology along with deeper investment. It reflects a strategic move away from the extensive, volume-based expansion of previous years towards a more sustainable and competitive value-chain upgrade.

EU-GMP: the gold standard

IMP4 Factory honoured in Binh Duong province’s Green Book. Photo: Imexpharm

Founded in 1977, Imexpharm quickly established a development strategy anchored in quality-driven decision-making across all aspects of its operations. From becoming the first pharmaceutical company in Vietnam to operate a non–beta-lactam manufacturing facility meeting GMP-ASEAN standards in 1997, Imexpharm has consistently set industry benchmarks.

Since 2014, the company has continuously invested in its factory system to meet EU-GMP standards. By the fourth quarter of 2016, it had become the first pharmaceutical enterprise in Vietnam to operate three EU-GMP–certified production lines simultaneously.

To date, it remains the domestic company with the largest number of EU-GMP–certified production lines, operating 12 lines across three manufacturing complexes – IMP2, IMP3, and IMP4.

Meeting the stringent requirements of EU-GMP allows businesses to master the technology for producing complex drugs and dosage forms such as multi-dose antibiotics, injectable drugs, and lyophilised powders for injection – segments that previously relied heavily on imported supplies. Through these capabilities, the company is reinforcing its role as a domestic manufacturer in the pharmaceutical supply chain.

EU-GMP is among the most rigorous pharmaceutical standards, requiring strict validation processes and regular reassessments by European regulatory authorities to ensure consistent and sustained quality.

Throughout production, raw material selection is governed by strict quality criteria and supplier compliance, in line with WHO-GMP and EU-GMP requirements. Meanwhile, the entire manufacturing process and associated data are continuously and tightly monitored, creating a transparent and robust foundation for product quality assurance.

R&D and international cooperation

Research and development activities at Imexpharm’s EU-GMP–certified Pharmaceutical Plant. Photo: Imexpharm

To strengthen its capacity to produce high-tech pharmaceuticals in compliance with EU-GMP standards, Imexpharm has intensified cooperation with leading global pharmaceutical companies such as Sandoz, Sanofi-Aventis, Pharmascience, and Genuone Sciences Inc.

Most recently, the share transfer of Imexpharm between SK Group and Livzon – a pharmaceutical group in finished drugs and pharmaceutical raw materials (APIs), with a diversified portfolio spanning chemical medicines, APIs, and biological products – is expected by experts to create new opportunities for the company to receive technology transfers and gain access to leading pharmaceutical manufacturing standards.

As science as well as technology and data increasingly drives rapid advances in pharmaceutical R&D, Imexpharm’s expanded international cooperation and technology transfer are viewed as a positive long-term prospect, enabling greater access to cutting-edge technologies and diversified product portfolios from global partners. This approach is widely regarded as a sustainable growth model that relatively few domestic pharmaceutical companies possess the resources and capabilities to pursue.

Strategic depth

With a strategy centred on deep investment in EU-GMP–compliant production capacity and international cooperation models, Imexpharm has sustained positive growth over many years. During 2020–2024, the company recorded a compound annual growth rate of 15.3 per cent in total revenue.

By the end of 2025, Imexpharm’s gross revenue reached VND2.91 trillion ($111.94 million), representing a 16 per cent on-year increase and exceeding the domestic pharmaceutical industry’s average growth rate of 9 per cent (based on industry data as of the end of third quarter in 2025). Net revenue totalled $93.86 million, up to 10.7 per cent, with balanced contributions from both OTC and ETC channels.

The ETC channel posted growth of 11.8 per cent, reflecting rising demand for EU-GMP–certified products and a shift towards higher-value pharmaceuticals. Meanwhile, the OTC channel recorded an 18.3 per cent increase amid the gradual recovery of the pharmaceutical retail market. Revenue from modern pharmacy chains rose sharply, contributing to broader market coverage and reinforcing the company’s brand positioning.

Gross profit margin in 2025 is expected to improve to 41 per cent, supported by effective cost control, optimised production planning, and enhanced operational efficiency across manufacturing facilities.

“As a pioneer in the industry, we are committed to building a solid growth foundation based on rigorous quality standards, responsible innovation, and the delivery of long-term value to all stakeholder,” said Tran Thi Dao, general director of Imexpharm.

Beyond the domestic market, Imexpharm continues to expand internationally, holding 28 marketing authorisations in Europe for 11 products and steadily increasing its presence to more than 40 countries and territories worldwide.

Imexpharm sees strong first half growth with $47 million in revenue Imexpharm reported strong first half results on July 18, with net revenue up 22 per cent on-year, reaching nearly half of its annual target.

Imexpharm’s EBITDA margin rises to 22.3 per cent driven by cost management and growth In September 2025, Imexpharm’s profit before tax surged by 101 per cent, while EBITDA increased by 48 per cent.

Imexpharm named Vietnam’s best place to work in pharmaceutical industry Imexpharm has been named the #1 Best Place to Work in Vietnam 2025 in the pharmaceutical, medical devices, and healthcare sector category.

At the customs-business dialogue meeting held by the Ministry of Finance in December, Ho Sy Hung, chairman of the Vietnam Chamber of Commerce and Industry (VCCI), noted that amid ongoing volatility both domestically and globally, the effective implementation of tax and customs policies is viewed by the business community as a critical factor in strengthening confidence, supporting recovery, and facilitating business activities.

Customs officials help businesses complete export procedures. Photo: Hai Anh

“Businesses highly appreciate the fact that customs authorities regularly organise dialogues, training sessions, and direct consultations, helping policies quickly translate into practice and minimize compliance risks,” the VCCI leader stated.

Administrative procedure reform and digital transformation continue to serve as central pillars of customs management. In the customs sector specifically, a myriad of concrete results have been recorded, including significant reductions in business conditions, shorter processing times, and lower compliance costs for enterprises.

Notably, administrative procedures have now been fully integrated into the National Single Window Portal and the National Public Service Portal.

The Ministry of Finance, including the customs sector, has issued and implemented numerous timely and practical support policies, contributing to stronger confidence and economic recovery and growth, particularly through policy dialogue, which has proven to be an effective channel for accompanying business development.

Based on feedback gathered from enterprises and industry associations, recent customs reforms have demonstrated positive progress, especially in the application of new regulations that are better aligned with practical realities, and ensuring the simplification of procedures, and the acceleration of IT adoption.

Automated clearance systems, online public services, and digitalisation solutions have helped businesses shorten customs clearance times, reduce logistics costs, and enhance predictability in import-export operations.

Addressing expectations for deeper customs procedure reform, Hung noted that in the context of deeper international integration, customs reform needs to be further advanced in a more substantive, synchronised, and consistent manner. Firms hope that procedures will continue to be simplified, particularly in specialised inspection stages.

“With the customs sector’s strong reform commitment and constructive spirit, VCCI expects the customs sector to remain a reliable partner for businesses, contributing to the promotion of import-export activities, investment attraction, and the creation of sustainable growth momentum in 2026 and beyond,” he stressed.

Regarding the development and refinement of customs policies and legislation, Nguyen Thanh Hung, deputy director general of the General Department of Vietnam Customs, said in an interview with the media before the customs-business meeting that a series of important resolutions issued by the Politburo, such as those on the development of sci-tech, innovation and national digital transformation; on international integration in the new context; or on private sector development- have provided a solid political foundation for institutional reform in the customs sector.

“All new regulations are geared towards simplifying administrative procedures, encouraging the digitalisation of dossiers, and facilitating import–export activities, while still ensuring state management requirements and combating smuggling and trade fraud. Improving the legal framework is a crucial prerequisite for completely renewing operational processes and gradually building digital and smart customs in line with international standards and practices,” Hung noted.

A notable highlight in recent customs policy and legal development has been the strengthening of consultations and dialogue with the business community.

Customs authorities have implemented various consultation formats, including public consultations on official portals, coordination with the VCCI, domestic and foreign business associations, and targeted groups of enterprises directly affected by specific policies.

In 2026, in addition to routine tasks, the customs sector is conducting a comprehensive review of the Customs Law in connection with the requirements of building digital customs.

On that basis, amendments and supplements to several provisions of the Customs Law are expected to be proposed for submission to the Ministry of Finance for reporting to the government.

“The revision of the Customs Law aims to create a solid legal basis for the comprehensive digital transformation of customs management, internalise international treaties, strengthen decentralisation and delegation of authority, and further improve the legal system towards reform, procedural simplification, openness, and transparency, while ensuring consistency and coherence with related laws and international agreements to which Vietnam is a signatory,” Hung said.

Customs reform to prioritize high-tech and innovative businesses Au Anh Tuan, deputy director general of the Department of Vietnam Customs, outlines key changes to the Customs Law aimed at simplifying procedures and offering more incentives for high-tech, innovative, and semiconductor businesses, and helping to support supply chains and boost the startup ecosystem.

MoF pledges fair, transparent tax policies for Korean investors The Ministry of Finance has held a dialogue with South Korean businesses, addressing tax and customs issues and pledging stronger support for investors.

Strengthening supply chains through trade promotions and customs reform The Vietnam Trade Promotion Agency (VIETRADE) is focusing on building safe and sustainable supply chains for enterprises in the new geopolitical context.