The generics industry: unlocking new growth drivers

The generics industry: unlocking new growth drivers

For the first time, generic antibiotics meeting EU-GMP standards are being produced in Vietnam, marking a pivotal shift in efforts to upgrade the pharmaceutical value chain and enhance competitiveness of the domestic drug industry.

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.

VIR