Italian CDMO Flamma arrives in the US

The Italian small molecule API manufacturer has acquired Teva’s cGMP chemical synthesis centre in Philadephia

Image as seen on company website

Flamma, the Italian small molecule API CDMO, has acquired Teva's Chemical Synthesis Center in Malvern, PA. The 40,000 sqft facility well located close to NY with CGMP capabilities.

Kenneth Drew, Sr Director of North America Sales and Business Development said: "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."

Drew added: "This facility will be a welcome addition to Flamma's current customer base as well. Having a US 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 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 of Flamma Innovation (the R&D unit within the Flamma Group), noted: "This is another example of the strategic vision for Flamma. The goal is to be recognised by customers as a strategic partner that is ready to invest when and where customers need us to."

The specs

The 40,000 sqft 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). Affectionately being dubbed "Flamma-delphia" for now, this well built 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 looks forward to reactivating the necessary licenses.

A US cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams

This site will be to be initially 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 and looks forward to attracting talented personnel

As part of the growing demands of the industry, Flamma has carefully examined various options over the past few years for growth. Flamma felt it was best to start a laboratory operation from the ground floor than try to incorporate an already existing business. By doing this, Flamma can continue to impart its culture to its employees from day one and bring value to customers knowing that the same family-owned and run culture permeates the new site.

This site will be able to quickly accommodate fast-tracked molecules and respond to the constantly growing analytical needs of today's projects.

Business strategy

This milestone complements the Flamma 2020 Plan to bring value to customers who are looking for a home for their projects and have numerous options to move it forward at the right time. These options include moving projects later on to Flamma's cGMP facilities in Italy, its cGMP facility in Dalian, China, or taking advantage of both by back integrating the project appropriately.

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 ~ US$10 million to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d'Isola headquarters soon.

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