We are a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and branded injectable and inhalation products. We currently manufacture and sell 15 products in the U.S. and are developing a portfolio of 13 generic and 7 branded injectable and inhalation products that primarily target markets with high technical barriers to entry.
Our largest product by net revenues is enoxaparin sodium injection, the generic equivalent of Sanofi’s Lovenox. Enoxaparin is a difficult to manufacture injectable form of low molecular weight heparin that is used as an anticoagulant, which helps prevent the formation of blood clots in blood vessels, commonly referred to as deep vein thrombosis. Enoxaparin is difficult to produce because the API is not easily obtained or manufactured. We manufacture the API for our enoxaparin product and perform all other manufacturing of the finished product in-house. We believe that our enoxaparin product not only demonstrates our scientific capabilities of developing therapeutically equivalent generic versions of drugs with large, complex molecules and overcoming numerous regulatory hurdles, but it also demonstrates our capabilities in characterizing complex molecules.
Our multiple technological capabilities enable the development of technically-challenging products. These capabilities include characterizing complex molecules, analyzing peptides, proteins and DNA, conducting immunogenicity studies, engineering particles and improving drug delivery through sustained release technology. These technological capabilities have enabled us to produce bioequivalent versions of complex drugs and support the development and manufacture of a broad range of dosage formulations, including solutions, emulsions, suspensions, and lyophilized products, as well as products administered via metered dose inhalers, or MDIs, and dry powder inhalers, or DPIs.
Our primary focus is developing products for markets with high technical barriers to entry. We are specifically focused on applying our technical expertise to develop products that:
leverage our research and development capabilities;
require raw materials or an active pharmaceutical ingredient, or API, for which we believe we have a competitive advantage in sourcing, synthesizing or manufacturing; and/or
improve upon an existing drug’s formulation with respect to drug delivery, safety and/or efficiency.
To complement our internal growth and expertise, we have made numerous strategic acquisitions of companies, products and technologies that collectively have strengthened our core injectable and inhalation product technology infrastructure, including providing additional manufacturing, marketing and research and development capabilities and the ability to manufacture raw materials, APIs and other components for our products.