Flamma gains a North American foothold near Philadelphia

Flamma, a contract development and manufacturing organization (CDMO) based in Bergamo, Italy, says it has acquired Teva’s Chemical Synthesis Center in Malvern, Pennsylvania. Financial details were not disclosed.

The 3,700 m² facility near Philadelphia will net Flamma its first research and manufacturing asset for active pharmaceutical ingredients (APIs) in North America. The company, which has two research and manufacturing sites in Italy, also has an R&D and manufacturing site for APIs in Dalian China.

The Malvern site brings Flamma about 1,800 m² of research laboratory space. In addition, the site features a pilot plant with hydrogenation capabilities comprised of four reactors ranging from 200 to 400 l, six standard kilolab suites, and one kilolab suite for highly potent API production. The plant will be dedicated to development and production of APIs from the preclinical stage to small-volume commercial scale production.

The former Teva facility, which closed last year, also has room for expansion. Flamma expects to employ 60 people there by 2023, according to Kenneth Drew, senior director of North American sales and business development.

The Italian firm is one of several European CDMOs that have been looking for a foothold in North America, where a wave of consolidation has limited CDMOs’s acquisition options.

Earlier this year, UK-based Sterling Pharma Solutions acquired CiVentiChem’s facility in Cary, North Carolina, one of a handful of CDMO sites still operating in North America. Among the European contract service firms that already have research and manufacturing assets in North America are Hovione, a Portuguese firm with a technology center in East Windsor, NJ, and the Italian CDMO Fabbrica Italiana Sintetici, with a plant in LaSalle, Quebec.

Drew says Flamma will be able to transfer early stage projects from the new plant to its facilities in Italy or China, an attractive option for US customers. The Malvern plant will also provide a base for growth at Flamma. “Having a US cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams,” says Drew.

Meanwhile, Flamma has added a cGMP kilolab and a high containment laboratory to handle genotoxic materials at its headquarters in Chignolo d’Isola. The company also intends to invest $10 million in a new building at its headquarters to further expand R&D capabilities.