ANI Pharmaceuticals expands CDMO business through Novitium acquisition

The purchase will allow the company to add nine new customers to its growing CDMO business and 27 manufacturing suites

The transaction will add nine new customers to ANI’s growing CDMO business and give it access to Novitium's 50,000-sq. ft East Windsor, NJ facility, including 27 manufacturing suites and eight clinical suites supporting R&D, commercial manufacturing and packaging.

An ongoing 20,000-sq. ft building expansion will add 18 new manufacturing suites. Novitium’s annual production capacity is approximately two billion units in aggregate across tablets, capsules, liquid suspensions and solutions, powders and powder for oral suspension, controlled-release and potent compounds.

The transaction is expected to close in the second half of 2021, subject to regulatory approvals and ANI shareholder agreement.

Novitium anticipates launching more than 25 additional products in 2021 and 2022, including products with FDA Competitive Generic Therapy designation. The company currently has 21 abbreviated new drug applications filed with the US Food and Drug Administration and more than 30 additional products under development.

Currently, the company is advancing three 505(b)(2) candidates in oncology and hypertension. These 505(b)(2) products will build on ANI’s increasing focus on niche opportunities, including its first Paragraph IV filing in 2020 and the filing of injectables ANDAs in 2021.

The integration of Novitium’s R&D operations will establish a center of excellence for ANI’s generics product development program.