Grifols receives approval from the European Medicines Agency to produce plasma in Egypt and export it

BarcelonaGrifols has received certification from the European Medicines Agency (EMA) for the entire value chain of Grifols Egypt for Plasma Derivatives (GEPD), a project by the Catalan multinational specializing in plasma derivatives in partnership with the Egyptian government. The authority responsible for the scientific evaluation, supervision, and safety control of medicines in the European Union (EU) confirmed that the entire Grifols Egypt plasma platform "operates under the most demanding European standards of quality, safety, and regulatory control," the company explains. Thanks to this certification, Egypt becomes 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 the medical evaluation of donors and the donation process to the analysis of the medicines" and the plasma processing. This also facilitates the country's progress toward exporting surplus medicines derived from Egyptian plasma to other markets, particularly in Europe, including Spain.

Tomás Dagá, Vice President of Grifols Egypt and member of Grifols' strategy committee, affirms that the EMA's decision "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 international quality standards."

This approval comes after Egypt announced it had achieved 100% self-sufficiency in blood products thanks to Grifols, making it the sixth country in the world capable of supplying its own plasma-derived medicines, after the US, Germany, Austria, the Czech Republic, and Hungary. The company maintains this strategy of vertical integration and local operations, which reduces the risk of being subject to tariffs and other national regulations, as it is considered a producer within the territory where it manufactures. This objective will allow Egypt to position itself as hub regional to supply the Africa and Middle East region with surplus blood products.

Blood products, the specialty of the Catalan multinational, are identified by the EMA itself as "essential medicines for treating serious, chronic, and life-threatening diseases for which there are no alternative treatments." Currently, 65% of the plasma used worldwide to manufacture medicines comes from the US, from which Europe imports nearly 40% of the plasma it needs. This heavy external dependence "highlights the vulnerability of the system to potential supply disruptions," Grifols emphasizes. The company states that the EMA certification of the Grifols Egypt project "has strategic relevance: it positions Egypt, in partnership with Grifols, as a new healthcare hub capable of contributing to strengthening the security of plasma supply in Europe." With a joint investment of €280 million, the public-private partnership between Grifols and the Egyptian government "has enabled the creation, in record time, of Africa's first comprehensive plasma ecosystem and one of the most advanced in the world." With 16 donation centers, and four more planned for 2026, a state-of-the-art analysis laboratory, and a comprehensive logistics center that guarantees traceability throughout the entire chain, the country has achieved clinical self-sufficiency in immunoglobulins, albumin, and clotting factors for the first time. The future processing plant, whose first phase will become operational in 2026, will complete the value chain within the country, avoiding dependence on the international market and expanding therapeutic options for patients with chronic and rare diseases.