FLAMMA USA completes commissioning of High Potent API suite
Malvern, PA, USA – November 1, 2021 – Flamma USA, part of the Flamma Group, (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that it has completed the re-commissioning of the High Potent API (HPAPI) suite.
Flamma is confident that this will provide a viable alternative for customers seeking development of early stage HPAPIs since the long lead times for other vendors is often problematic. The Flamma team has gone through an exhaustive 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 USA”.
Flamma USA has grown to 35 people and are currently working on a variety of projects for numerous companies. These projects are typically pre-clinical that often require 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 USA 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 tactic allows for Flamma Honkai to make 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.
For further information, please visit the Flamma website at http://www.flammagroup.com.
Contact Flamma
Kenneth Drew, Ph.D., VP Flamma USA
1-617-515-0975