ANI Pharmaceuticals, Inc. has signed an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals for an undisclosed ANDA soft gel oral drug product. Sofgen will provide development, manufacture and regulatory submission of the drug, and ANI will be responsible for marketing and distribution in the U.S.
 
The branded product had annual U.S. sales of approximately $1 billion, according to IMS Health. Financial terms were not disclosed.
 
Arthur S. Przybyl, ANI’s president and chief executive officer, said, “I am pleased to have expanded our collaboration with Sofgen through the addition of this second generic drug development project. ANI will continue to invest in both internal R&D efforts as well as external partnerships with high quality partners such as Sofgen.”