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Norwich Adds Non-GMP Development Services

Small-scale feasibility and initial development added to Norwich repertoire

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Norwich Pharmaceuticals is expanding its services to include small-scale feasibility and initial product development for Rx and OTC drugs. According to the company, the non-GMP development facility will offer Norwich customers greater flexibility and speed when assessing the feasibility of technical concepts and formulations, and create streamlined progression from clinical into scale-up and through commercial manufacturing.

“Establishing feasibility and initial product development capabilities fills a significant unmet need for customers who are seeking a complete range of services from a contract provider. It also underscores our focus to build a robust capability for all stages of the product lifecycle,” said Chris Calhoun, president of Norwich Pharmaceuticals.

The new facility is comprised of an analytical laboratory designed for potent compound handling, and a development area enabling formulation and product transfer verification. The company also has a pilot plant for technology transfer and small-scale manufacturing.

The product development unit is led by Dr. Robert E. O’Connor, Ph.D., vice president of product development and technical services. Dr. O’Connor has more than 30 years of domestic and international pharmaceutical experience. Before recently joining Norwich, he was the vice president of product support for J&J, where he served in a leadership capacity since 2003. His team is comprised of more than 40 employees.

“With these new capabilities, we are now able to move directly from initial product development into our existing GMP pilot plant for process optimization, clinical supply manufacturing and submission batch production,” indicated Dr. O’Connor. “Our experienced team has the expertise and resources to convert a concept into a feasible formulation ranging from liquids to solid dose, including immediate and extended release delivery systems.”

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