Flamma USA, part of the Flamma Group, a CDMO that develops, manufactures, and commercializes small molecule APIs for the pharmaceutical industry, has completed the re-commissioning of its High Potent API (HPAPI) suite.
 
Flamma is confident that this will provide a viable alternative for customers seeking development of early stage HPAPIs since long lead times for other vendors is often problematic. Flamma has undergone an extensive qualification of the HPAPI suite over the past six months in order to bring this offering to the marketplace.
 
“This is a strategic step for Flamma as we have been asked to explore other therapeutic areas for our customers,” said Gianmarco Negrisoli, President Flamma USA. “Recently, there has been interesting discussions about onshoring so we see this as a logical step to provide the opportunity to bring back manufacturing into the U.S.”
 
Flamma USA has grown to 35 people and is currently working on a variety of projects for customers. These projects are typically preclinical, often requiring a combination of GLP tox material that is quickly followed up with 1-5 kg of GMP material from the pilot plant. Located outside of Philadelphia, Flamma USA allows customers the ability to stay within the U.S. for the early development of their small molecule drug candidates.
 
Flamma has the ability to leverage obtaining starting materials and key intermediates from Flamma Honkai in Dalian, China. This allows for Flamma Honkai to take the first few steps of the route before allowing Flamma USA to complete the GMP work in the pilot plant while potentially condensing timelines. Meanwhile, future growth can be accommodated in Italy as the project matures.