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June 30, 2006
By: Tim Wright
Editor-in-Chief, Contract Pharma
Forest Laboratories, Inc. and Tropon GmbH signed a manufacturing agreement for the production and packaging of a solid, oral antibiotic based on faropenem medoxomil at Tropon’s Cologne manufacturing plant. This antibiotic is currently under review by the FDA. Forest Labs will use Tropon’s manufacturing capabilities for the U.S. markets with the licence holder for the product, Replidyne Inc. Tropon has worked with Replidyne on the commercialization of this product for the past two years, setting up a dedicated manufacturing area in Cologne. Utilizing existing buildings, Tropon designed a house-in-house concept for creating a totally separate and independent, on-site manufacturing area for antibiotics. The area incorporates facilities for handling API, blending and tabletting, as well as additional packaging capabilities for blister and bottle packaging. The new manufacturing area also includes labs and technical services to avoid any potential cross-contamination with other manufacturing areas at the Cologne site. After finalizing the technical equipment, the target is to obtain final FDA approval for this new manufacturing area by the end of 2006. Commercial production is scheduled to start in the first half of 2007.
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