Technology Innovation
Impax continues to invest in state-of-the-art equipment, people, and facilities, in order to provide the highest level of research and development, manufacturing, and customer service. Our quality assurance team works closely with our suppliers to ensure purity, consistency, and quality of products, and we strive to bring value to our customers with innovative products in key therapeutic areas.
One of our strengths is our experience in developing controlled-release products. We have developed a number of different controlled-release delivery technologies that can be utilized with a variety of oral dosage forms and drugs. We believe that these technologies are flexible and can be applied to develop a variety of pharmaceutical products, both generic and branded. Our technologies utilize a variety of polymers and other materials to encapsulate or entrap the active pharmaceutical ingredients and to release them at varying rates or at predetermined locations in the gastrointestinal tract.
Our generic product development strategy is based on a combination of speed to filing and a legal strategy primarily predicated upon non-infringement of established brand name pharmaceuticals. We are focused on targeting high-margin, first-to-file or first-to-market product opportunities. In 2010, we incurred $44 million in generic R&D and submitted 10 Abbreviated New Drug Applications to the FDA.
Our brand product development strategy is based on targeting significant unmet needs in the CNS market. We typically focus on improving the clinical utility of existing molecules utilizing our proprietary technologies, following a 505(b)(2) regulatory pathway of approval. The goal is to utilize our expertise in drug-delivery technology to offer innovative products that enhance the care of patients with CNS disorders. In 2010, we incurred $42 million in brand R&D to further the development of our leading drug candidate IPX066 for Parkinson’s disease.
Manufacturing
We manufacture our finished dosage form products at our Hayward, California, facility and our Taiwan facility and use our larger and lower operating cost Philadelphia and New Britain, Pennsylvania, facilities to package, warehouse and distribute the products. We began full-scale manufacturing in the Hayward facility in June 2002 and believe we have sufficient capacity to produce new products for the immediate future based on the facility’s estimated annual production capacity of up to approximately 1.2 billion tablets and capsules. We completed construction of our Taiwan facility and received FDA approval in 2009. In early 2010, we commenced commercial manufacturing of commercial products from the Taiwan facility. We estimate the Taiwan facility’s annual production capacity is approximately 450 million tablets and capsules and has potential for additional expansion.
In April 2011, we announced expansion to double Taiwan's facility’s square footage and initially increase annual capacity to approximately 700 million tablets and capsules. The two-year project, is scheduled for completion in the fourth quarter of 2012. The expanded facility has been designed with the superstructure and infrastructure to install additional equipment capable of supporting annual production of 1.5 billion tablets and capsules as necessary to support future growth.
