Flamma USA opens doors to HPAPI suite

The CDMO says the suite will help to "bring back manufacturing to the US"

The fully integrated CDMO, which develops, manufactures, and commercialises small molecule APIs, has spent the last six months bringing this capability to the marketplace.

Given the long lead times of other vendors, the company says it is confident the suite will provide a viable alternative for customers seeking development of early-stage HPAPIs.

According to Gianmarco Negrisoli, President Flamma USA, the move is also a "logical step" in the current onshoring drive to "bring back manufacturing to America".

Flamma USA is part of the family-owned and run Flamma Group based in Bergamo, Italy. In total, the group has four manufacturing site: two in Italy (Chignolo & Isso), one in China (Dalian) as well as the Philadelphia facility.

Flamma, therefore, can obtain starting materials and key intermediates from its China facility before allowing Flamma USA to complete the GMP work in the pilot plant, thus potentially condensing timelines while enabling customers to stay within the US for the early development of their small molecule drug candidates.

The CDMO is 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.