Grifols has received certification from the European Medicines Agency (EMA) for the entire value chain of Grifols Egypt for Plasma Derivatives (GEPD) in Egypt.
The approval confirms 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 rigour of the work carried out by the teams involved during 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."
“With Grifols’ seal of quality and safety and the certification of European authorities, Egypt is in a position to become a key player in the international pharmaceutical industry."
"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 US, 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 African and Middle Eastern regions.
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 €280m and a focus on education, knowledge transfer and skilled employment, the public-private partnership between Grifols and the Government of Egypt has enabled the creation of Africa’s first fully integrated plasma ecosystem and one of the most advanced in the world.
With 16 donation centres, plus four more expected in 2026, a state-of-the-art testing laboratory and an integrated logistics centre 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 centres and more than 100,000 free medical check-ups have been provided to donors.
The accumulated clinical impact of plasma therapies exceeds €80m 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 Organisation for Primary Immunodeficiencies), enabling training programmes 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 €55m to Egypt’s GDP and is expected to reach more than €272m annually by 2030.
In the 2026-2029 growth plan, direct investments of nearly €209m will generate a total impact exceeding €700m, driven by the project’s direct, indirect and induced effects.