AMRI announced that it has entered into a development and long term exclusive commercial supply agreement with Parnell Manufacturing Pty Ltd (Parnell), an Australian company specializing in the research, development and manufacture of veterinary products. Under the agreement, AMRI will provide process development, manufacturing and supply of active pharmaceutical ingredients (APIs) to support Parnell’s submission of a New Animal Drug Application (NADA) with the United States Food and Drug Administration (FDA) and commercial launch of its veterinary product onto the US market pending regulatory approval. The development and manufacture of this API will take place at AMRI’s facilities in Albany , NY. The product is currently sold commercially in several countries outside of the US including Australia, New Zealand, Singapore, Hong Kong and Dubai.
“We are pleased to support Parnell in its introduction of this important veterinary product to the US market,” said AMRI Chairman, President and CEO 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 US FDA standards. We look forward to working with Parnell to expeditiously achieve regulatory approval, a successful project launch and great success in the US 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 CEO Robert Joseph.
Founded in 1991, Albany Molecular Research, Inc. provides scientific services, products and technologies focused on improving the quality of life. AMRI works on drug discovery and development projects and conducts manufacturing of active ingredients and pharmaceutical intermediates for many of the world’s leading healthcare companies. As an additional value added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense to a strategic partner. With locations in the U.S. , Europe, and Asia, AMRI provides customers with a wide range of services, technologies and cost models.