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
ken.drew@flammagroup.com
About Flamma:
FLAMMA is a family owned & run, fully integrated CMO based in Bergamo (near Milan in
Northern Italy) established in 1950.
FLAMMA is a company specialized in the cGMP manufacture of APIs, NCEs, RSMs, and
advanced intermediates for the pharmaceutical industry. Flamma has particular expertise in
high value chiral materials specifically amino acid related materials. Flamma also
manufactures specialty compounds and advanced intermediates for the nutraceutical and
cosmetic industries and has several generic products.
FLAMMA has four manufacturing facilities all with R&D labs- Italy (2), China, and the USA.
Both cGMP Italian locations (Chignolo & Isso) are regularly inspected by the FDA and AIFA.
Flamma Honkai, located in Dalian, China, has a new R&D building as well as a cGMP
production plant. Flamma provides security when working in China with our 100% owned,
self-managed facilities that deliver results without worry. Flamma reliably supplies materials
directly to customers and/or delivers materials to its cGMP facilities in Italy in order to deliver
the customer’s compound on-time and with the desired specifications. Flamma offers costeffective
services to customers looking for a trusted partner within China.
Flamma USA is located outside Philadelphia provides Flamma with the ability to service
customers looking to keep materials in the USA for pre-clinical/early stage clinical
development.
Being a fully integrated company allows Flamma to move your compounds quickly along their
journey taking into consideration all aspects necessary for the success of your project.
Flamma can be of assistance for early stage pre-clinical development of small molecules as
well as for large-scale commercial manufacturing. With a total reactor capacity of 450 m3 and
over 600 employees, see why Flamma should be your next contract manufacturer.
FLAMMA – THE THINKING CDMO tm.
For more information, please visit www.flammagroup.com
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