Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 88

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 88
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istaseal™/Veraseal®, a biological fibrin sealant composed of fibrinogen and human thrombin used in surgical operations to expedite the healing process. This product is commercialized in the United States and Canada, in some European countries (i.e. Germany, United Kingdom, Switzerland, Estonia, Latvia, Lithuania, Austria, Ireland, Netherlands, France and Italy) as well as in South Korea, Taiwan, Singapore, Puerto Rico, Israel and Australia by Johnson & Johnson MedTech (a Johnson & Johnson company). In 2024, VistaSeal™ received approval to treat surgical bleeding in pediatric patients with its fibrin sealant solution in the United States, Canada and Australia.
To sell medicinal products, we must first register the products with the relevant authorities of the jurisdictions where the products are to be marketed and sold. To comply with the regulatory requirements in a given jurisdiction, we have a core team in Spain and the United States that prepares, files and coordinates the registration process with the technical personnel at the subsidiary assigned to that jurisdiction. As of December 31, 2024, we had 1,101 Biopharma product licenses registered in 90 countries throughout Europe, the United States, Latin America, Asia and the rest of the world. As of December 31, 2024, our most significant government-issued licenses for Biopharma products are:

●   Gamunex®/Gamunex®-C/Flebogamma® DIF. We have 223 licenses for the marketing and sale of one or more IVIG products;
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●   Xembify®. We have 35 licenses for the marketing and sale of this product;
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●   Prolastin®/Prolastin®-C/ Prolastin®-C Liquid/Prolasplan®/Prolastina®/Pulmolast®/Lynspand®. Alpha 1-Proteinase Inhibitor (Human). We have 64 licenses for the marketing and sale of one or more of these A1PI products;
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●   Fanhdi™/Alphanate®/Koate®- DVI Factor VIII. We have 220 licenses for the marketing and sale of one or more of these Factor VIII products;
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●   Albutein®/Human Albumin Grifols®/Plasbumin®. We have 283 licenses for the marketing and sale of one or more