Generic Division

URL Pharma’s generic segment encompasses multiple levels of the generic value-chain including formulation development, manufacturing, and distribution. We utilize state of the art technology to maximize flexibility, profitability and quality control. URL Pharma has 288 ANDA (FDA generic) approvals, our manufacturing facilities in Philadelphia received multiple consecutive clean FDA inspection reports (FDA-Form 483) over the last three years, and we expanded our manufacturing technology base through the 2009 acquisition of the assets of PharmPro in Chicago.

With a 63 year history distributing and manufacturing generic drugs, peaking with the manufacturing of 2.5 billion tablets and capsules in 2005, we projected that the manufacturing of U.S. generic drugs would move to Asia resulting in intense commodity price and profit deterioration. Thus, in 2004, we formed our branded and technology division and have directed most of our R&D budget towards new branded product development since then.

The result has been a shift in our profit from generic to branded pharmaceuticals and technologies as shown in the graph below. We have also retasked our manufacturing resources, including people and equipment, towards our branded product development. This has enabled us to speed new product ideas into formulation development and clinical studies at a rate that has astounded our Pharma partners in multiple projects and led to rapid development of our novel product pipeline. Our NDA approvals in 2009, Colcrys® and Fibricor™, both benefited from these capabilities.

While we continue to leverage our 63 years of generic experience for selected new generic product opportunities and authorized generic sales, marketing, and distribution for brand companies, our emphasis has clearly shifted towards our branded and technology pipelines.