Chignolo D’Isola, Bergamo, Italy – June 15, 2024 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, was recently recognized by the China-Italy Chamber of Commerce (CICC). The CICC recognizes and rewards Italian companies that have excelled in the previous year in terms of investment, growth, resilience, and innovation in China.

At the 13th “Panda d’Oro” (Golden Panda) Gala Award 2024 in Shanghai, Flamma was presented the prestigious “Panda d’Oro Turnaround Award”. This award is in recognition to the Italian company that faced a particular critical moment and, led by its management team, successfully made improvements through effective operations to achieve greater stability and profitable results.

Gian Paolo Negrisoli, President and CEO, commented “We are very proud to accept this prestigious award which  is a testament to the hard work, dedication, and innovation that our team has demonstrated over the years. I would like to extend my heartfelt thanks to  all  the authorities, the China-Italy Chamber of Commerce, the Ambassador of Italy to the People’s Republic of China, Mr. Massimo Ambrosetti and the Italian consulate as well as to all  our employees!”

“This award is not only a symbol of our commitment to excellence but also a reminder of the power of collaboration and friendship between our nations and cultures, as we make chemistry with an human touch. Xiexie, Grazie, Thanks.”

Flamma is currently completing an expansion to their Dalian, China facility, Flamma Honkai, with the addition of a new API manufacturing site with 200 m³ of capacity that will be completed in early 2025. This expansion with double the current capacity at Flamma Honkai from 200 m³ to 400 m³ helping to provide more options when working at Flamma across its entire network in Italy and the USA.

Download press release here

Chignolo D’Isola, Bergamo, Italy – December 14, 2023 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, was recently recognized by the Italy China Council Foundation (ICCF) for being a Top Investor in China . The event which had over 250 guests included many personalities from the world of culture, sport and entertainment.

“The China Awards are now a traditional event, which Class Editori has been organizing for years with what was once the Italy China Foundation and is now the Italy China Council Foundation”, said Paolo Panerai, Publisher and CEO of Class Editori.

“This is a unique event, and a very specific point of reference in relations between Italy and China, because it is rewarding companies from the two countries for their cross-economic activity and is equivalent to promoting development and harmony between their respective peoples”.

Early in 2023, Flamma announced the commitment to invest $250M over the next three years. Included in this investment was a significant investment at Flamma Honkai to complete a new GMP facility. The investment will increase Flamma Honkai’s capacity from 200 m³ of small molecule API/NCE capacity to initially 400 m³ and then ultimately to 600 m³. Additionally, new technologies will be added to the site such as flow technology

Gianmarco Negrisoli, Executive Director, stated, “Flamma is thankful for this recognition from the ICCF. We will continue our mission to provide value to the companies that we work with. We will do our part to bring new and innovative drugs to the global pharmaceutical marketplace.”

Download Press Release

Chignolo D’Isola, Bergamo, Italy – September 19, 2023 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, announced the another addition to its Continuous Flow capabilities with the addition of a Corning G4 Microreactor.

The installation of a Corning G4 Microreactor will bring significant advantages for flow production including improved selectivity and safety allowing production using a reduced footprint.

“This new technology will provide the ability to work at higher pressures more easily than utilizing a batch process. We will also look to take advantage of more green processes that include recycling,” said Massimo Verzini, Flamma’s Head of Global R&D.

“Safety of operations is always a priority for Flamma. The addition of Continuous Flow Technology enables us to safely manage energetic reactions while maintaining tight control of product quality as well as process yield.”

In July 2023, Flamma released news regarding the impending installation of a new suite of equipment from Microinnova, a leader in modular Continuous Flow systems. The addition of the Corning G4 micro-reactor along with the MicroInnova system will provide a flow plant that can achieve conditions to 16 bar, up to 145°C, up to 30 L/hour and a 50 MT/year (depending on the process). Installation is underway with qualification batches set for February 2024.

We anticipate that customers will embrace this new technology and Flamma’s team will provide quotations that consider this as an option when looking over customer RFPs.

Download press release

Chignolo D’Isola, Bergamo, Italy – July 19, 2023 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, announced the expansion of its Continuous Flow capabilities with the investment of ~$2M starting with the installation of a new suite of equipment from Microinnova, a leader in modular Continuous Flow systems.

“Flamma has been quietly growing our Continuous Flow capabilities over the past several years”, according to Massimo Verzini, Head of Global R&D at Flamma. “This new technology will provide the ability to work at a higher pressure more easily than a batch process as well as take advantage of a green process with recycling”.

The introduction of this production system equipment will be made at Flamma’s Chignolo Italian facility later this year. This was designed and built to be “partially modular” thus allowing for the exchange of reactor modules as needed. This increases the flexibility at Flamma and would allow customers to bring forth other products using different reaction requirements yet allow Flamma to produce materials using the same system in place.

Flamma previously announced in March that it was investing over $200M over the next three years including the addition of new technologies across its sites. This is an example of Flamma’s commitment to bring value to its customers whether they are current or future customers. Flamma has a network that consists of sites located in Europe, North America and China. They continue to develop Flamma USA in near Philadelphia to provides innovator companies the flexibility to begin early stage small molecule projects within the USA and then have the opportunity to move their project to other parts of the Flamma Group as the project grows.

Download press release here

Chignolo D’Isola, Bergamo, Italy – March 20, 2023 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, announced the commitment to invest $200M over the next three years. This significant investment will propel Flamma forward as it continues to respond to market demands that require future growth and opportunity.

Flamma will use the investments for the following projects:

• Revamping and improvement of the Bulciago, Italy site that was acquired in 2022.
• Completion of a new GMP facility at its Dalian, China location. Flamma Honkai will increase from 200 m³ of small molecule API/NCE capacity to initially 400 m³ and then ultimately to 800 m³.
• The addition of new technologies across its sites in Italy, China and the USA.
  • Including growing the existing flow chemistry capabilities at Flamma Italy
  • Build out of an API clean room at Flamma USA
  • Additional improvements to the HPAPI capabilities at Flamma USA
• Additional improvements will be made at Flamma’s two other Italian facilities, Chignolo and Isso. These site improvements include upgrades to the existing analytical services offered as well as the installation of new equipment, including reactors, filter dryers,   distillation units. To harness the power of renewable energy, Flamma will be adding solar panels as well.

In consideration of the current geo-political environment, Flamma is proactively securing customers supply chains by having the ability to transfer projects from China (Flamma Honkai) to Italy (specifically its Bulciago site). Flamma offers the market a unique value proposition where one can still work in China but also have the security to also work simultaneously in Italy. Alternatively, work can be done in China but can be internally transferred to Italy if unforeseen events transpire giving customers the piece of mind that cannot be afforded by other CDMOs. Flamma believes that having a supply chain that is protected is extremely important. In addition, the Chinese domestic market will grow dramatically in the coming years and Flamma Honkai’s facilities in China can be the right choice for developing and producing APIs in China for its domestic market.

Dr. Gianpaolo Negrisoli, Chief Executive Officer of Flamma, noted, “Flamma will continue to reinvest in itself to provide further flexibility between all of our sites.”

Flamma Bulciago has reactor capacities up to 25,000 L with an average reactor size of 12,000 L. This GMP site is an attractive option for those companies looking for additional capacities in Europe. The combination of Bulciago along with Chignolo and Isso provides Flamma with 900 m³ of small molecule manufacturing capacity in Italy.

Flamma has built a network that now consists of sites located in Europe, North America and China. The continued development of Flamma USA in near Philadelphia provides innovator companies the flexibility to begin early stage small molecule projects within the USA and then consider using the rest of the Flamma Group for its needs as the project grows. Since Flamma can often make the necessary RSMs, the security of supply is strengthened by Flamma’s ability to provide internal backup to manufacturing.

“Our future is very bright. We are aware of customer sensitivity about their supply chain. Years of work and huge investments have been placed into their molecules. This cannot be jeopardized by looking for the lowest price or underestimating the risks of a weak supply chain. We have manufacturing facilities with different characteristics to meet customer needs. This includes capacity and technologies along with a very skilled and committed team that works hard to be a long term partner”, concludes Negrisoli.

Executive Director of Global Business Fabrice Cornille, Ph.D. presented this news at the DCAT 2023 Member Company Announcement Forum on March 20, 2023.

Download the pdf of the press release here

On October 10, 2022, Flamma Honkai celebrated the groundbreaking of a new API site with a ceremony held at the Songmudao Chemical Park in Dalian, China. Flamma Honkai will ultimately triple in size when this expansion is completed with the addition of 400 m³ to its already existing 200 m³ of capacity. Construction is underway with a target for completion by late 2024/early 2025.

This ceremony was attended by officials and leaders of the Jinpu District Government and the Songmudao Chemical Park.

Bulciago, Italy, – September 10, 2022- Flamma hosted an open house event at the Bulciago, Italy site that was acquired earlier this year. Workers, their families and local area residents were invited to the event and were welcomed into the Flamma family. Feel free to see the video from the event below.

Flamma was selected a Top CMO/CDMO in Europe for 2022.

Read more at https://www.pharmatechoutlook.com/flamma

Chignolo D’Isola, Bergamo, Italy – March 16, 2022 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry as well as a preeminent Contract Development and Manufacturing Organization (CDMO) of New Chemical Entities (NCEs) and late stage intermediates for the Innovator Companies, announced that it will acquire a third API manufacturing site in Italy as of April 2022.

Flamma reached an agreement earlier this year with Teva Group for acquiring Sicor Bulciago site located in Lecco, Italy , only 30 km from 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).

This acquisition strengthens and expands Flamma’s manufacturing services as a fully integrated CDMO that is privately held and family run since 1950. The ability to integrate Bulciago into the Flamma Group will be enhanced by the proximity of the site as well as the familiarity of numerous current Flamma employees who previously worked at the site.

Dr. Gianpaolo Negrisoli, Chief Executive Officer of Flamma, noted, “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 adds, “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”, added Negrisoli.

Flamma has been busy over the past few years with the addition of Flamma USA in Malvern, PA just outside Philadelphia to handle early stage small molecule projects. The soon to be completed R&D expansion at Chignolo that will quadruple its R&D space there and allow for not only more R&D capabilities but allows for additional analytical resources in the building that was shared between the two groups. Flamma will invest over € 150M  ($167M) over the next three years for increasing capacity and the addition of new technologies across its sites in Italy, China and the USA.

“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”, concludes Negrisoli.

Chignolo D’Isola, Bergamo, Italy – November 1, 2021 – Flamma SpA (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, proudly announces that Flamma Honkai has passed its final  inspection by the Chinese National Medical Products Administration (NMPA) formally known as the Chinese FDA.

This milestone marks Flamma’s ongoing efforts to continue to bring significant value and trust from its customer base.

“The effort by not only the Flamma Honkai team but the entire Flamma team is a testament to our desire to provide the type of quality that is expected at every Flamma site”, said Kenneth Drew, Ph.D., VP Flamma USA. “Many people are understandably worried about working in China. Flamma has long maintained that we have many Italian sites but one happens to be located in China. Our attention to customer needs helps to set us apart from other CDMOs.”

Flamma is looking to expand our footprint within China and will be moving towards another workshop in the Songmudao Chemical Park in the province of Liaoning. While chemical parks located near Beijing & Shanghai are facing heavy environmental scrutiny & random chemical park closures, being located away from these areas as well as being in a special chemical park located outside of the city of Dalian provides a sense of stability and security.  

Flamma Honkai can help companies looking to manufacture APIs within China for the Chinese marketplace. Companies can also take advantage of our Italian sites for APIs as well making Flamma unique within the industry.

Download press release (pdf)

For further information, please visit the Flamma website at http://www.flammagroup.com.

Contact Flamma

Kenneth Drew, Ph.D., VP Flamma USA

ken.drew@flammagroup.com

1-617-515-0975