ANI Pharma enhances generics and CDMO business through Novitium acquisition

The transaction expands ANI’s R&D pipeline and adds nine new customers to its growing CDMO business

Since signing the deal back in March this year, Novitium has scored 13 new drug approvals (several of which were limited competition launches), completed a successful FDA GMP inspection, and reported strong EBITDA growth.

In the next 18 months, the company plans to launch 20+ new products, including those with Competitive Generic Therapy designation.

Novitium's founders, Samy Shanmugam, Chad Gassert and Vijay Thorappadi, will drive the combined company's R&D division.

As well as expanding ANI's R&D pipeline focused on niche opportunities, the transaction also expands dosage forms to include injectables and gels.

Acquiring Novitium also adds nine new customers to ANI's CDMO business and a state-of-the-art manufacturing facility in East Windsor, New Jersey, enhancing manufacturing capabilities and CDMO opportunities.

Recently raised funds also provides ANI the flexibility to integrate Novitium into the company and fund commercialisation efforts for its Purified Cortrophin Gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome.

Nikhil Lalwani, President and CEO of ANI described Novitium as a "world-class R&D engine in the generic and 505 (b)(2) sectors" with a "highly compliant" manufacturing facility.