FDA Approves Bolognana Site for Ryplazim Manufacturing

Fort Lee, NJ, USA, November 19, 2024 /PRNewswire/ – Kedrion Biopharma Inc. is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the company’s manufacturing facility in Bolognana, Italy, to produce RYPLAZIM®. This plasma-derived human plasminogen is indicated for treating patients with plasminogen deficiency type 1 (PLGD-1), a rare and challenging chronic

Following the agreement of binding terms signed in July 2024, Kedrion Biopharma Inc. and Biotest AG have now finalized the contractual terms of the long-term strategic agreement for the full commercialization and distribution of Biotest Immunoglobulin Yimmugo® in the United States. The exclusive distribution agreement requires Biotest to supply and Kedrion to purchase minimum quantities