Flamma SpA, a contract development and manufacturing organization (CDMO) that develops, manufactures, and commercializes small molecule active pharmaceutical ingredients (APIs) for the pharmaceutical industry, has acquired Teva’s Chemical Synthesis Center in Malvern, PA in the Philadelphia area.
 
“The industry knows and respects the Flamma brand, yet some customers are apprehensive when considering the placement of a project overseas. Flamma understands this and feels that this will be a good option for those wanting to initially start a project close to home,” said Kenneth Drew, senior director, North America sales and business development, Flamma. “This facility will be a welcome addition to Flamma’s current customer base as well. Having a U.S. cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams. Using our unique model of Flamma Academy, we will be able to have R&D chemists from both Italy and China to spend time in the Philly area labs and understand what customers want a first-hand. It also helps to bring the entire company together by pairing Italian, Chinese and American scientists together. Flamma is the ‘Thinking CDMO’.”
 
GianMarco Negrisoli, president, Flamma Innovation, the R&D unit within the Flamma Group, said, “This is another example of the strategic vision for Flamma. The goal is to be recognized by customers as a strategic partner that is ready to invest when and where customers need us to.”
 
The 40,000 square foot facility is in close proximity to Boston/Cambridge (1.5 h flight) as well as the greater New York/New Jersey area (1.5 h drive). Dubbed “Flamma-delphia” for now, this lab and manufacturing site possesses a cGMP pilot plant with hydrogenation capabilities as well as wet-milling, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or  warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma says it looks forward to reactivating the necessary licenses.
 
This site will initially be dedicated to the development and production of APIs ranging from pre-clinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023.
 
This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest approximately $10 million to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.