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news.ANI Pharmaceuticals, an integrated specialty pharmaceutical company, and Sofgen Pharmaceuticals, a niche pharmaceutical company, have signed an exclusive licensing, development and supply agreement for the development of an ANDA soft gel oral drug product.
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Financial terms of the agreement were not disclosed by the two companies.
Pursuant to the terms of the agreement, Sofgen Pharmaceuticals will be responsible for development, manufacturing and regulatory submission of the drug, while ANI Pharmaceuticals will be responsible for marketing and distribution in the US.
ANI Pharmaceuticals president and CEO Arthur S Przybyl noted that the company is pleased to have expanded its collaboration with Sofgen Pharmaceuticals 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," Przybyl added.
According to IMS Health, the product had branded annual US sales of approximately $1bn prior to recent generic entry.