CDMOs Axplora and Flamma have both made announcements about investments in flow chemistry, with the former completing the installation of a new cGMP pilot unit at Leverkusen, Germany, and the latter investing about $2 million in flow, starting with the installation of a new suite of equipment from Microinnova at Chignolo D’Isola, Italy.
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.