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AMRI and Parnell Manufacturing Pty Ltd. have entered into a development and commercial supply agreement, under which AMRI will provide process development, manufacturing and supply of APIs to support Parnell’s New Animal Drug Application (NADA) with
April 7, 2011
By: Tim Wright
Editor-in-Chief, Contract Pharma
AMRI and Parnell Manufacturing Pty Ltd. have entered into a development and commercial supply agreement, under which AMRI will provide process development, manufacturing and supply of APIs to support Parnell’s New Animal Drug Application (NADA) with the FDA, as well as the commercial launch of the veterinary product in the U.S., pending approval. Development and manufacture of the API will take place at AMRI’s facilities in Albany, NY. “We are pleased to support Parnell in its introduction of this important veterinary product to the U.S. market,” said AMRI chairman, president and chief executive officer Thomas E. D’Ambra, Ph.D. “Our new relationship with Parnell illustrates again AMRI’s ability to provide integrated support covering development and manufacturing to U.S. FDA standards. We look forward to working with Parnell to expeditiously achieve regulatory approval, a successful project launch and great success in the U.S. market.” “Parnell sought expressions of interest for the development and long-term supply of this API from several companies and we are pleased that AMRI was ultimately successful in their tender. This product is an extremely important project for Parnell and the FDA compliant development is paramount to the successful launch,” said Parnell chief executive officer Robert Joseph.
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