The Flamma Group, a global company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry and a Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates, will acquire a third API manufacturing site in Italy as of April 2022.
 
Flamma reached an agreement to acquire Teva Group’s Sicor Bulciago site in Lecco, Italy, near Flamma’s headquarters. It has a long history of established cGMP manufacturing of pharmaceutical materials including APIs. It has more than 600 cubic meters of manufacturing capacity and has been previously inspected by the FDA, the Italian Ministry of Health (AIFA), the Brazilian Health Regulatory Agency (ANVISA) and has been accredited by the PDMA (Japan).
 
Dr. Gianpaolo Negrisoli, Chief Executive Officer of Flamma, said, “We are extremely happy to bring the Bulciago site into the Flamma Group of companies. This allows us to rapidly enhance our CMC offerings to our customers by providing further flexibility between sites. Having the ability to produce more generic APIs in Italy is in line with the European Pharmaceutical strategy aiming to reshore by having a more robust and resilient supply chain in the pharmaceutical sector that is not totally dependent on Asia.”
 
Negrisoli added, “For this reason, we could not allow this factory, so important, with a history of more than 50 years and a production and technological tradition of great value, to disappear. We are very proud to be able to guide its rebirth towards very significant production goals. With Bulciago, Flamma adds 600 cubic meters of available manufacturing capacity bringing our total capacity in Italy to over 900 cubic meters. This goes along with the soon to be 600 cubic meters of manufacturing capacity in China as we begin expansion of Flamma Honkai this year.”
 
Over the past few years, the CDMO added Flamma USA in Malvern, PA to handle early stage small molecule projects. Also, an R&D expansion at Chignolo will soon quadruple R&D space to allow more R&D capabilities and for additional analytical resources in the building that was shared between the two groups. Flamma will invest over $167 million over the next three years to increase capacity and add new technologies across its sites in Italy, China and the U.S.

“This is an exciting time at Flamma as we continue to grow to over 1,500 cubic meters of total manufacturing capacity yet still maintain our roots as a family owned and run company focused on developing long term relationships with customers that are looking for a true partner moving forward in their drug development CMC needs,” Negrisoli concluded.