The US Food and Drug Administration has authorized Centeon, the bloodproducts joint-venture between Franco-American company Rhone-Poulenc Rorer and Hoechst of Germany, to distribute newly-manufactured biological products from its Kankakee, Illinois facility, subject to the industry's normal practice of lot-release testing by the FDA prior to distribution.
Centeon had to recall its albumin products last year, and has not been permited by the FDA to manufacture products at the plant until it meets certain criteria (Marketletters passim). R-PR, its parent company Rhone-Poulenc, and JV partner Hoechst AG all took significant financial charges in 1996, and in the first quarter of 1997, as a result of the product recall.
R-PR said the authorization is significant for several reasons: Centeon will submit biological products manufactured at the facility for lot-release testing in the next few weeks; R-PR can resume normal distribution of pharmaceutical products manufactured by Centeon for R-PR at Kankakee, which are not subject to lot-release testing; and R-PR can complete the necessary steps to conduct filings worldwide for Synercid (quinupristin/dalfopristin), its treatment of resistant bacterial infections in the second half of this year. Kankakee is one of the designated sites for production of Synercid.
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