Albany Molecular Research, Inc., a provider of contract services to a variety of biotechnology and pharmaceutical companies, recently announced that it has formed a development and long-term commercial supply agreement with Parnell Manufacturing Pty Ltd (PARNELL), an Australian based company that specializes in the research, development, and manufacturing of veterinary products.
Per terms of the agreement, AMRI will provide process development, manufacturing and supply of active pharmaceutical ingredients, or APIs, that will be supporting Parnell’s submission of its New Animal Drug Application (NADA) with the US Food and Drug Administration (FDA) and the commercial launch of its veterinary product onto the US market pending regulatory approval. The development and manufacturing for this API will be taking place at AMRI’s facilities, located in Albany, NY. The product is currently being retailed commercially in various countries abroad, including New Zealand, Australia, Hong Kong, Singapore, 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.
The company also recently announced that they have appointed Peter J. Hansbury as the new Vice President of Aspectic Services at AMRI, located in Burlington, Massachusetts. Peter Hansbury will be reporting to Dr. Steven Hagen, vice president of pharmaceutical development and manufacturing.
“We are pleased to welcome Mr. Hansbury to the AMRI leadership team,” said AMRI Vice President, Pharmaceutical Development and Manufacturing Steven Hagen. “His expertise and experience in both the business of manufacturing and marketing specialty injectibles and sterile products make him an excellent choice for this business realizing an upswing in productivity and sales activity.”
“We are excited to recruit Mr. Hansbury into this leadership role for our sterile fill and finish facility,” aid Chairman, CEO and President Thomas E. D’Ambra, Ph.D. “We have been singularly focused on upgrades to systems and technology in pursuit of a full endorsement from the U.S. FDA and Mr. Hansbury joins us at a critical time as we resume GMP operations in Burlington. We believe his diverse experience spanning operations, quality, and sales and marketing will be an important contributor to the overall short and long term success of AMRI’s Burlington operation.”
For more information on the company, visit its website at: www.albmolecular.com
Let us hear your thoughts below:
