CDMO Flamma Group is to invest about $200 million over the next three years across its network of sites in Italy, the US and China, as it “continues to respond to market demands that require future growth and opportunity”. This includes:

* Revamping the site at Bulciago, Italy, that was acquired in 2022

* Completing the new GMP facility at the Flamma Honkai site in Dalian, China, where small molecule API and NCE capacity will ultimately quadruple to 800 m³ to meet growing domestic demand

CDMO Flamma has acquired a third API manufacturing facility in Italy from Teva. The Sicor Bulciago site at Lecco has had multiple regulatory inspections. Terms were not disclosed.

“This allows us to rapidly enhance our CMC offerings to our customers by providing further flexibility between sites,” said CEO Dr Gianpaolo Negrisoli. “Having the ability to produce more generic APIs in Italy is in line with the European pharmaceutical strategy aiming to reshore.”

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.