Grifols obtains approval from the European Medicines Agency for the entire value chain of Grifols Egypt

Barcelona, Spain, December 16, 2025 - Grifols, S.A. (MCE: GRF, NASDAQ: GRFS), a global leader in plasma-derived medicines and innovative healthcare solutions, has received certification from the European Medicines Agency (EMA) for the entire value chain of Grifols Egypt for Plasma Derivatives (GEPD) in Egypt. The authority responsible for the scientific evaluation, supervision and safety control of medicines in the European Union has endorsed that the entire Grifols Egypt plasma platform operates under the most demanding European standards of quality, safety and regulatory control.

This recognition positions Egypt as the first country in Africa and the Middle East to operate a fully integrated plasma collection and processing system that meets the strictest international standards throughout the entire cycle, from donor medical assessment, donation, testing and plasma processing to the supply of plasma-derived medicines to patients. This milestone enables the country, once national needs are met, to move forward with exporting surplus Egyptian plasma-derived medicines to other markets, particularly Europe.

Tomás Dagá, Vice President of Grifols Egypt and member of Grifols Board’s Strategy Committee, said: “This certification confirms the quality and rigor of the work carried out by the teams involved over these five years to create Africa’s first integrated plasma platform and align it with the most demanding international quality and safety standards. EMA’s certification of Grifols Egypt ensures that the medicines obtained from this plasma may be supplied to other markets once Egypt’s national requirements are met.”

Dagá added: “With Grifols’ seal of quality and safety and the certification of European authorities, Egypt is in a privileged position to become a key player in the international pharmaceutical industry, supported by an industrial project, the creation of skilled local employment, the development of local expertise and the ability to meet national healthcare needs. Grifols has a long-term commitment to Egypt and its public health and will continue working to ensure the stable supply of essential medicines, which is already a reality.”

This approval follows Egypt’s announcement that it had achieved 100% self-sufficiency in plasma-derived medicinal products thanks to Grifols, making it the sixth country in the world capable of supplying itself with medicines derived from national plasma, after the U.S., Germany, Austria, the Czech Republic and Hungary. This milestone will allow Egypt to position itself as a regional hub to supply surplus medicines to the Africa and Middle East region.

Egypt, a new healthcare hub for Europe with Grifols’ seal

Plasma-derived medicines are identified by the EMA as critical and essential medicines for treating severe, chronic and potentially life-threatening diseases for which no alternative treatments exist. These medicines improve both life expectancy and quality of life for people suffering from deficiencies in certain plasma proteins, and the ability to rely on additional, robust supply chains that meet the highest standards of quality and safety for donors and patients directly contributes to strengthening the continent’s healthcare resilience.

Currently, 65% of the plasma used worldwide to manufacture plasma-derived medicines comes from the United States, from which Europe imports nearly 40% of the plasma it needs. This heavy external dependence exposes the system to vulnerability in the event of supply disruptions. EMA’s certification of the Grifols Egypt project is of strategic significance: it positions Egypt, in partnership with Grifols, as a new healthcare hub capable of helping reinforce Europe’s plasma-supply security.

This regulatory recognition aligns with the priorities of the new SoHo Regulation, which highlights the need to ensure a stable supply of plasma-derived medicines. In this regard, Grifols Egypt, under the “Grifols Seal,” strengthens Grifols’ existing capacity to support the European market’s supply.

This certification is further underpinned by the successful completion of PPTA (Plasma Protein Therapeutics Association) inspections to ensure compliance with the highest safety and quality standards in the new facilities.

An unprecedented economic, social and healthcare impact

With a joint investment of €280 million and a focus on education, knowledge transfer and skilled employment, the public-private partnership between Grifols and the Government of Egypt has enabled, in record time, the creation of Africa’s first fully integrated plasma ecosystem and one of the most advanced in the world.

With 16 donation centers, plus four more expected in 2026, a state-of-the-art testing laboratory and an integrated logistics center ensuring traceability across the entire chain, the country has achieved clinical self-sufficiency in immunoglobulins, albumin and coagulation factors for the first time. The future processing plant, whose first phase will become operational in 2026, will complete the entire value chain within Egypt, reducing dependence on the international market and expanding therapeutic options for patients with chronic and rare diseases.

This healthcare progress translates into tangible outcomes: more than one million vials produced with Egyptian plasma have been delivered to public hospitals and health centers, and more than 100,000 free medical check-ups have been provided to donors. The accumulated clinical impact of plasma therapies exceeds €80 million in health benefits thanks to increased diagnosis, treatment and preventive capacity. Egypt has also strengthened its healthcare infrastructure through collaborations with the World Federation of Hemophilia (WFH) and IPOPI (International Patient Organization for Primary Immunodeficiencies), enabling training programs and donations of coagulation factors that enhance system resilience and autonomy.

From an economic and social perspective, the project has become a national driver. In 2025, Grifols, through Grifols Egypt, will contribute €55 million to Egypt’s GDP and is expected to reach more than €272 million annually by 2030. Over the 2026–2029 growth plan, direct investments of nearly €209 million will generate a total impact exceeding €700 million, driven by the project’s direct, indirect and induced effects. This development is also reflected in employment: 1,200 highly skilled direct jobs have been created to date, together with more than 14,000 indirect and induced jobs; and between 2026 and 2029 the creation of a total of 186,000 new jobs is expected.

Local capacity building is another strategic pillar of the project. The Grifols Academy for Plasmapheresis, the first African institution dedicated to this technical training, has delivered more than 170,000 hours of instruction under international standards and has prepared Egyptian personnel to operate the system with full autonomy. This is complemented by collaboration with national universities to train specialized profiles and consolidate an independent professional ecosystem.

About Grifols Egypt for Plasma Derivatives (GEPD)

Grifols Egypt for Plasma Derivatives is a joint-venture company between Egypt’s National Service Projects Organization and Grifols. Under the terms of the joint venture, NSPO owns 51% and Grifols the balance. The strategic partnership’s combined expertise, technology and resources seek to strengthen Egypt’s healthcare system through achieving self-reliance in plasma-derived medicines while reinforcing Grifols’ international expansion in the Middle East and Africa.