Kedrion announces FDA Approval for Rhogam® Fill and Finish in Melville

Kedrion Biopharma announces that the U.S. Food and Drug Administration has approved  its application for the transfer of the Rhogam® aseptic filling, visual inspection, labelling/packaging and associated analytical testing from Ortho Clinical Diagnostics to its Melville plant. This milestone is an important step toward the Company eventually being in a position to produce RhoGAM® entirely from start to finish, using Kedrion Biopharma plasma.

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