Flamma completes HPAPI suite

Flamma USA, the North American arm of the Italian CDMO, has completed the re-commissioning of the HPAPI suite at its site at Malvern, Pennsylvania, following an “exhaustive qualification” over the past six months. This is meant to be a viable alternative for customers early stage HPAPIs when lead times are long for others.

“This is a strategic step for Flamma as we have been asked to explore other therapeutic areas for our customers”, said Gianmarco Negrisoli, president of 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 now employs 35 people and is currently working on a variety of projects for different customers, typically starting with pre-clinical toxicology studies that soon move onto requiring 1-5 kg of GMP material from the pilot plant. Later stage projects move to the main site near Bergamo.

The company sources starting materials and key intermediates from its Flamma Honkai site in Dalian, China. It has also announced that this site has just passed its final inspection by the Chinese National Medical Products Administration, formerly known as the Chinese FDA.

This, the company claims, means that customers can rely on Western quality levels from a Chinese site. Flamma added that it is moving towards another workshop in the Songmudao Chemical Park in Liaoning province. This is well away from the Beijing and Shanghai areas, where operators “are facing heavy environmental scrutiny and random chemical park closures”, thus giving an extra layer of security.