Kedrion announces FDA Approval for its plasma fractionation facility in Melville

Kedrion Biopharma announces that the U.S. Food and Drug Administration has approved  its application submitted last July 23rd, 2018 to resume manufacture of Fraction II+III, Fraction V and Cryo Paste at the manufacturing plant Kedrion Biopharma Inc (KBI) Melville, NY. This approval allows Kedrion to continue the internalization and expansion strategy of its product portfolio.


About Kedrion

Kedrion is a leading biopharmaceutical company that specializes in the development, production and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders and conditions such as immune system deficiencies and coagulation disorders.

The Company operates through a fully integrated business model from the collection of plasma in its own centers in the United States, Hungary and Germany to fractionation and production in its manufacturing facilities located in Italy, Hungary and the United States.

Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,600 employees and a commercial presence in approximately 100 countries worldwide.

Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves.

Additional information about Kedrion can be found at