Towa International obtains approval for the production and export of Magnesium Esomeprazole to Towa Pharmaceutical in Japan

•  Towa International receives certification from Japan’s PMDA for its production plant located in Martorelles.

•  Towa International’s production plant strengthens the production capabilities of the Towa Group in Japan, addressing the challenge of ensuring a stable supply in Japan.

 

Barcelona, February 29, 2024 – Towa International, an international holding specializing in the research, development, manufacturing, marketing, and distribution of generic and value-added medicines, distributing directly in Europe and the United States through its commercial subsidiaries, Towa Pharmaceutical and Breckenridge Pharmaceutical, and in over 30 countries through its B2B unit, announces today the approval, effective from February 14, for the manufacturing and marketing of Magnesium Esomeprazole «Towa» 10 mg/20 mg capsules for the Japanese market. This milestone represents the first time that Towa International produces for its parent company, Towa Pharmaceutical, consolidating knowledge and capabilities synergies within the Towa Group and entering the third-largest generic market globally after the United States and Europe.

The approval includes the integration of the Martorelles Plant, located in Spain and operated by the Towa International holding, into the production chain of Towa Pharmaceutical in Japan. The production plant, in compliance with the standards of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), has obtained approval from the Japan Pharmaceuticals and Medical Devices Agency (PMDA). With this new approval, Towa International will not only strengthen the Group’s production backup system but also significantly contribute to addressing the current challenge of ensuring a stable supply in Japan.

This strategic step aligns with Towa International’s four-year plan of internationalization and capacity expansion, with a total investment of over 25 million euros in the enhancement of its production and R&D facilities and more than 55 million euros in its R&D pipeline. This milestone also reinforces Towa International’s leadership in modified release technology (pellets). Towa International was the first company globally to launch the generic Omeprazole through a non-infringing patent using its pellet technology. Currently, Towa International has a second generation of Omeprazole with a smaller capsule for easier product intake, which is more sustainable than the previous version. Towa International is the leading producer of Omeprazole in France, Spain, and other European Union member countries(1).

David Peix, CEO of Towa International, emphasizes that «this milestone marks a key moment in the evolution of Towa International. The effective collaboration between our parent company and our international hub, and the achievement of this approval, demonstrate our strong capabilities, technology, and know-how to operate in the largest international markets. We are committed to continuous development, leveraging the strengths of our group to achieve new milestones in the future and continue with our international expansion plan to reach the maximum number of patients worldwide.»

Japanese Market Situation and the Role of Towa Pharmaceutical

Towa Pharmaceutical is committed to the sustainable supply of quality generic products to ensure access to quality medicines for patients worldwide. Currently, the supply stability of the Japanese pharmaceutical industry is being compromised. Towa Pharmaceutical, the parent company of the international hub, has made significant capital investments to increase its production capacity to meet the demand for generic products, which represent 80% of the pharmaceutical market in Japan. Recently, instability in the supply of generic products has been severely impacted due to quality issues in other companies in the sector. In response to these events, Towa Pharmaceutical, as a leader among generic manufacturers in Japan, with three production plants in Japan, has worked on installing new machinery and increasing personnel to boost production and ensure a stable supply. The annual production capacity reached 14 billion units in the second half of 2022, and a third solid formulation building is nearing completion to achieve a capacity of 17.5 billion units from 2024. Additionally, there are plans to double the annual production capacity of vials from 5 to 10 million by constructing a second sterile formulation building. Towa Pharmaceutical also plans to introduce more automated equipment to enhance efficiency, addressing challenges arising from the aging population in Japan.