Chignolo D’Isola, Bergamo, Italy – October 7, 2024 – The Flamma Group  (“Flamma”), a global, fully integrated company producing and commercializing small molecule Active Pharmaceutical Ingredients (APIs) for the life science industry, in order to effectively support and consolidate its remarkable growth, proudly announces the appointment of Giorgio Bertolini as the new General Manager for Italy.

Giorgio will report directly to the Flamma’s CEO, Gian Paolo Negrisoli. As General Manager Italy, he will be responsible for the objectives and the economic results of Flamma’s three Italian sites. He will coordinate and harmonize the operational and management activities across the three sites  ensuring that all their activities are aligned with the management’s long term strategic vision and the company values

Along with a degree in chemistry, Giorgio has more than 30 years of experience where he has held significant roles with other CDMOs within the pharmaceutical industry. Giorgio brings a deep knowledge of our business, extensive experience and broad vision. We are confident that he will add significant value within the Flamma Group.

Giorgio notes “I am truly honored to join Flamma, a company renowned for its rapid expansion in reaction capabilities, advanced technological platforms, and growing international presence. I’m stepping onto a train that’s already in motion, but I’m fully committed to driving further growth and ensuring that we continue to deliver products and projects to our customers on time and in full.”

Gian Paolo Negrisoli, Flamma CEO, commented “As Flamma continues to grow, we will continue to be proactive in order to bring value to our customers. We are confident that Giorgio will use his experience to help Flamma achieve the goals we have in place. We are excited for the future and know that Giorgio will be instrumental in our continued growth and success.”

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Chignolo D’Isola, Bergamo, Italy – August 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, announced a cooperative agreement with Seven Star Pharmaceutical Services (SS) to expand its solid state science services.

This collaboration will allow Flamma to service customers more effectively by identifying the proper version of their API. By looking at a variety of areas such as salt & co-crystal selection, crystallization development, polymorph investigation, and pre-formulation evaluation, this partnership will look to solve typical problematic areas in the development of new drugs.

Gianmarco Negrisoli, President Flamma USA, commented “We have been working with Seven Star for several years and felt that it was time to formalize our collaboration. The proximity to Flamma USA coupled with the expertise in house at Seven Star will be beneficial to existing and new customers. Solving crystallization issues early on can speed development and scale up which, in turn, is beneficial to all parties involved.”

“Working with the Flamma USA team has been rewarding. Our ability to turn projects around quickly has helped their customers succeed in their attempts to get their molecule into the clinical. We are very proud to be part of the process to bring new drugs forward,”  says Sathyanarayana ‘Reddy’ Perumalla, Ph.D.,  Founder and Director, Seven Star Pharmaceutical Services. Flamma USA offers customers an easy entry point into the Flamma Group. Specializing on early stage & pre-clinical development of new drugs, the Malvern, PA facility can leverage Flamma Italy and Flamma Honkai to provide multiple options for securing ones supply chain.

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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.

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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.”

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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.

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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

The Flamma Spring 2023 Newsletter can be found here. Learn about Flamma is less than 5 minutes.

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.

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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

Malvern, PA, USA – November 1, 2021 – Flamma USA, part of the Flamma Group,  (“Flamma”), a preeminent Contract Development and Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small molecule Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, is proud to announce that it has completed the re-commissioning of the High Potent API (HPAPI) suite.

Flamma is confident that this will provide a viable alternative for customers seeking development of early stage HPAPIs since the long lead times for other vendors is often problematic. The Flamma team has gone through an exhaustive qualification of the HPAPI suite over the past six months in order to bring this offering to the marketplace.

“This is a strategic step for Flamma as we have been asked to explore other therapeutic areas for our customers”, said Gianmarco Negrisoli, President 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 has grown to 35 people and are currently working on a variety of projects for numerous companies. These projects are typically pre-clinical that often require a combination of GLP tox material that is quickly followed up with 1-5 kg of GMP material from the pilot plant. Located outside of Philadelphia, Flamma USA allows customers the ability to stay within the USA for the early development of their small molecule drug candidates.

Flamma has the ability to leverage obtaining starting materials and key intermediates from Flamma Honkai in Dalian, China. This tactic allows for Flamma Honkai to make the first few steps of the route before allowing Flamma USA to complete the GMP work in the pilot plant while potentially condensing timelines. Meanwhile, future growth can be accommodated in Italy as the project matures.

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

The Flamma Newsletter for October 2021 can be found here. Learn about Flamma is less than 3 minutes.

August 4, 2021: There was a CPhI Live Panel discussion entitled: “The Real Cost of Bringing Manufacturing Home”. The panel discussion is available on demand (see below).

Many years before the pandemic the industry has highlighted the importance of a globalized supply chain and in particular the heavy reliance on Asian suppliers. The situation fueled calls from political leaders and lawmakers for U.S. manufacturers to start producing critical supplies domestically. But what will be the cost of bringing manufacturing home, and who will the burden lie on?

If you are registered for CPhI North America, you can log on and view the webcast replay of the live panel discussion that featured Wayne Weiner (Pharmatech Solutions), David Gaugh (Sr. VP for Sciences and Regulatory at Association for Accessible Medicines), Bikash Chatterjee (CEO at Pharmatech), and Ken Drew (VP Flamma USA).

Chignolo D’Isola, Bergamo, Italy – June 22, 2021 – Flamma was recently spotlighted in Chimica Oggi-Chemistry Today. The article is entitled “A Word With Flamma” and featured a question and answer segment with Kenneth Drew, Ph.D., VP Flamma USA. Drew speaks about Flamma’s long history, building relationships with customers, reliable supply chains, and much more.

You can read the article by going to this page or you can download it here.

About Flamma:

FLAMMA is a family owned & run, fully integrated CDMO based in Bergamo (near Milan in Northern Italy) established in 1950.

FLAMMA is a company specialized in the cGMP manufacture of APIs, NCEs, RSMs, and advanced intermediates for the pharmaceutical industry. Flamma has particular expertise in high value chiral materials specifically amino acid related materials. Flamma also manufactures specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries and has several generic products.

FLAMMA has four manufacturing facilities all with R&D labs- Italy (2), China, and the USA. Both cGMP Italian locations (Chignolo & Isso) are regularly inspected by the FDA and AIFA. Flamma Honkai, located in Dalian, China, has a new R&D building as well as a cGMP production plant. Flamma provides security when working in China with our 100% owned, self-managed facilities that deliver results without worry. Flamma reliably supplies materials directly to customers and/or delivers materials to its cGMP facilities in Italy in order to deliver the customer’s compound on-time and with the desired specifications. Flamma offers cost-effective services to customers looking for a trusted partner within China.

The Malvern, PA site located outside Philadelphia provides Flamma with the ability to service customers looking to keep materials within the USA for pre-clinical/early stage clinical development as well as small scale commercial manufacturing.

Being a fully integrated company allows Flamma to move your compounds quickly along their journey taking into consideration all aspects necessary for the success of your project.

Flamma can be of assistance for early stage pre-clinical development of small molecules as well as for large-scale commercial manufacturing. With a total reactor capacity of 450 m³ and over 600 employees, see why Flamma should be your next contract manufacturer. FLAMMA – THE THINKING CDMO^TM.

Published February 12, 2020. A quick 2 minute update from Flamma and the activities ongoing.

Please click here or use this url https://conta.cc/3rJqwin

Chignolo D’Isola, Bergamo, Italy – November 5, 2020 – 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, is proud to announce that it has entered into an agreement with Gilead earlier this year to be part of the network of manufacturers contributing to the Veklury® (remdesivir) supply chain.

Flamma will continue to use its sites in Italy and China to support the need for necessary compounds in an effort to help COVID-19  patients in need.

“Covid-19 hit very close to home as Flamma is located in the Bergamo, one of the most affected areas in Italy. Our facility in Dalian, China  remained in full operation after the extended Chinese New Year after adding proper precautions to protect the safety and health of its employees,” noted Gian Paolo Negrisoli, CEO. “Our Italian team members utilized the protocols learned from our Chinese team and instituted them in Italy. This allowed our teams there to continue to support our customers with little to no interruption to the supply chain”.

The Flamma team has strived to provide continuous manufacturing support for remdesivir, maintaining timelines for current and upcoming projects due to the global and local needs. “This pandemic brought forth many challenges but Flamma responded to all of them with dedication and a team spirit by working tirelessly to be a part of the pharmaceutical supply chain to help those in need” notes Kenneth Drew, Ph.D., VP Flamma, USA.

During the Covid-19 crisis, Flamma teams in Italy and China have continued production of important molecules that are critical to help fight the virus. The Italian team hung a sign reading #MOLAMIA which means ‘Don’t Give Up’. Flamma doesn’t give up. This is another example of the commitment, made to not only customers but employees, to be a first-class organization. Flamma is very proud of the opportunity to support Gilead and remdesivir in the fight against Covid-19, and will continue to do all it can to be active partner in the development of breakthrough treatments.

About Veklury® (remdesivir):

Veklury (remdesivir) is an investigational nucleotide analog invented by Gilead, building on more than a decade of the company’s antiviral research. Multiple ongoing international Phase 3 clinical trials are evaluating the safety and efficacy of Veklury for the treatment of COVID-19. Based on available data from these studies, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide. Additional ongoing international clinical trials continue to further evaluate the safety and efficacy of Veklury in different patient populations and formulations, and in combination with other therapies.

About Flamma:

FLAMMA is a family owned & run, fully integrated CDMO based in Bergamo (near Milan in Northern Italy) established in 1950.

FLAMMA is a company specialized in the cGMP manufacture of APIs, NCEs, RSMs, and advanced intermediates for the pharmaceutical industry. Flamma has particular expertise in high value chiral materials specifically amino acid related materials. Flamma also manufactures specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries and has several generic products.

FLAMMA has four manufacturing facilities all with R&D labs- Italy (2), China, and the USA. Both cGMP Italian locations (Chignolo & Isso) are regularly inspected by the FDA and AIFA. Flamma Honkai, located in Dalian, China, has a new R&D building as well as a cGMP production plant. Flamma provides security when working in China with our 100% owned, self-managed facilities that deliver results without worry. Flamma reliably supplies materials directly to customers and/or delivers materials to its cGMP facilities in Italy in order to deliver the customer’s compound on-time and with the desired specifications. Flamma offers cost-effective services to customers looking for a trusted partner within China.

The Malvern, PA site located outside Philadelphia provides Flamma with the ability to service customers looking to keep materials within the USA for pre-clinical/early stage clinical development as well as small scale commercial manufacturing.

Being a fully integrated company allows Flamma to move your compounds quickly along their journey taking into consideration all aspects necessary for the success of your project.

Flamma can be of assistance for early stage pre-clinical development of small molecules as well as for large-scale commercial manufacturing. With a total reactor capacity of 450 m³ and over 600 employees, see why Flamma should be your next contract manufacturer. FLAMMA – THE THINKING CDMO^TM.

Chignolo D’Isola, Bergamo, Italy – October 2020: Flamma CEO Gian Paolo Negrisoli gives his views on the industry and Flamma in the latest issue of Chemistry Today. This issue focuses on the Italian Pharma Outlook.

Please go to Chemistry Today to see the article using this link:

Chemistry Today October 2020 issue

Chignolo D’Isola, Bergamo, Italy – September, 2020: Flamma was selected as one of the Welfare Champion 2020 companies that obtained the 5 W of the PMI Welfare Index rating and which constitutes the backbone of the Italian economic fabric.

The Welfare Index PMI is the initiative, promoted by Generali Italia with the participation of the major Italian confederations – Confindustria, Confagricoltura, Confartigianato, Confprofessioni, Confcommercio – to spread the culture of corporate welfare among companies. Obtaining a 5 W means that the company has:

* relevant welfare breadth (at least 8 areas among those identified)

* high intensity (several initiatives for each area)

* orientation to social innovation

* relevant economic and organizational commitment

* involvement of workers

The Index is scientifically constructed: research criteria and methodology are subjected to the control of a Steering Committee made up of all the partner trade associations of the project, institutional representatives and experts from industry and academia.

Extraordinary stories of companies that have placed health and safety at the center of their corporate objectives and have increased their commitment also in assistance, training, work-life balance.

Businesses have been the immediate point of contact for employees, their families, and communities. These are realities characterized by the widest welfare system (by number of activated areas) and which are characterized by the number and intensity of initiatives, degree of employee involvement and economic and organizational commitment to corporate welfare. In particular, this year the Welfare Champions have shown great ability to react and resilience to the impact of the Covid crisis.

Here is a video:  https://youtu.be/-oDWuDqr8AQ

Full post: https://www.flammagroup.com/flamma-selected-as-a-2020-welfare-champion-recipient/

As part of their Wednesday Chats, TKS Publishing interviewed Gianmarco Negrisoli, President of Flamma USA, on July 8, 2020. This short video interview gives one a glimpse of what Flamma is all about. If you have about ten minutes, it is worth your time.

Chignolo D’Isola, Bergamo, Italy – June 19, 2020 – 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, will bring forth a novel way to learn about Flamma and their offerings. Beginning June 26^th, Flamma will host a series of 15 minute informational meetings online every 4^th Friday of the month.

There will be no need to register or sign in since the online experience will take place in a virtual meeting room. This allows people to take advantage of the technology available to us yet remain anonymous. Flamma values your privacy and does not feel it is useful to have one sign up with their full contact information to learn about Flamma’s offerings.

This series of virtual meetings will allow those located in varying time zones to selected what time works for them. There will be three separate meetings held on the following Fridays: June 26, July 24, August 28, September 25 and October 23 at the following times:

9:00AM ET/15:00 CET (morning on the East Coast, afternoon in Europe)

8:00AM PT/11:00AM ET/17:00 CET (morning on the West Coast, evening in Europe)

11:00AM PT/2:00PM ET (late morning on the West Coast, afternoon on the East Coast)

Join anonymously using the following link: https://pexip.me/meet/0148100399

During these challenging times, there are still pharmaceutical projects that need to move forward thus finding the right outsourcing partner is critical. Flamma wants to provide sourcing professionals, CMC team leaders, executives from large and small companies and anyone else (including competitors) the opportunity to expand their CDMO portfolio.

Chignolo D’Isola, Bergamo, Italy – May 21, 2020 – 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, is proud to announce the ground breaking for their new R&D building. While most CEOs use a gold plated shovel, Flamma’s CEO Gian Paolo Negrisoli, used an excavator to mark the groundbreaking of the new R&D Building at Flamma’s headquarters in Chignolo d’Isola, Bergamo, Italy.

This marks the expansion at Flamma’s headquarters that will allow Flamma to quadruple its R&D space. The R&D building will accommodate 50 additional employees providing additional R&D and analytical development laboratories as well as offices and meeting rooms. In addition to these features, there will be a lab for high containment and special chemistries.

During the Covid-19 crisis of 2020, our teams in Italy and China worked tirelessly to continue production of important molecules that are critical to help fight the virus. The Italian team hung a sign reading #MOLAMIA which means ‘Don’t Give Up’. Flamma doesn’t give up. This important milestone is another example of the commitment made to not only customers but employees to deliver a first class organization where people want to place their projects.

The new R&D building will serve as a complement the R&D work being done at Flamma USA in Malvern, PA outside of Philadelphia. The team in the USA continues to grow as more projects come on board. For further information, please visit the Flamma website at http://www.flammagroup.com.

View a one minute video here: https://vimeo.com/424568102

Chignolo D’Isola, Bergamo, Italy – April 16, 2020 – Flamma has been named the Best Global Pharmaceutical CDMO according to the 2020 Biotechnology Awards.

Read more at: https://www.ghp-news.com/issues/biotechnology-awards-2020/

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, would like to thank the 2020 Biotechnology Awards for their selection of Flamma. This is a testament to the entire Flamma team.

Published April 9, 2020. A quick 2 minute update from Flamma and the activities ongoing.

Please click here or use this url https://conta.cc/2VreoUX

Chignolo D’Isola, Bergamo, Italy – April 6, 2020 – 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, is proud to announce that Flamma has been named a Top 10 CMO in Europe by Pharma Tech Outlook. Read more at:

https://cmo-europe.pharmatechoutlook.com/vendor/flamma-group-spearheading-the-pharma-supply-chain-cid-681-mid-64.html

March 11, 2020

Re: Covid-19 outbreak and impact to Flamma Italy

Dear Partners and Friends,

I would like to reach out and provide you with a better picture of what the situation looks like in Italy and at Flamma. As you are reading in the newspapers, the situation in Italy is worsening every day: infections are growing exponentially and we don’t know when the peak will hit. The majority of the people infected manifest light symptoms and can be cured at home but many still need hospitalization and, a few, but still too many, are critical and need Intensive Care Units, unfortunately for weeks and not for days.

As Italian, I’m very proud of our Healthcare system but with these numbers even the best system will collapse and we are very close to this point. When my friends at hospital say that they’ll need soon to select which patients can be admitted and which not, you can understand that we reacted too little and too late.

As many others, I underestimated the danger. I thought that doctors words were exaggerated and with few precautions, we would have been safe from Covid19. Now, I can say that it was a big mistake because infections are still growing and the latest measures taken by the government were extremely necessary to stop the infection growth. Unfortunately the impact on our activity is extremely significant.

Flamma, till now, worked at full stream despite the emergency as well as the seasonal flu which typically reduces the workforce. We are now compelled to slow down the production from next week because the transportation of raw materials, mainly solvents, will worsen and because we are facing a progressive reduction of our workforce.

As of today no employee has tested positive for the virus. We took important measures to prevent infections inside the company. These include: 20% of our employees are currently working remotely from home; we have completely segregated teams on shifts in Production, QC, and RD, limiting contacts between these teams; we are doing sanitization between shifts in the changing room; enforcing strict rules for accessing to the cafeteria and break areas and reviewing procedures to work at distance; we manufactured large volumes of liquid sanitizer because it’s not available in the market , like masks : we are now buying them from china after having sent thousands to Honkai last month. Situation in China has significantly improved, thanks to the very strong measures implemented. Flamma Honkai now works at full stream and is delivering without issues by air and, with some delays, by sea.

I’m writing you this letter asking you to not underestimate the Coronavirus issue. The curve of infections in other countries is already similar to what we had in Italy some days ago and, I suppose, in the USA it will likely happen with a one or two week delay. Please take immediate decisions that we took too late and follow the most basic rules by especially limiting exposure to public areas.

At Flamma, we feel we are on the front line to deliver treatment to patients who need it now more the ever. We plan to continue our activity until we are able to guarantee the health and safety of our people. There will be for sure some delays but I want to assure you that the entire Flamma team is highly committed in delivering what is most needed now. It will be our duty to inform you immediately if the situation changes in the next few days.

I want to thank you for your support in this difficult time and for your trust in Flamma as a partner.

Sincerely,

Gian Paolo Negrisoli

President and CEO

Chignolo D’Isola, Bergamo, Italy – November 21, 2019 – 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, is proud to announce that Mr. Gian Paolo Negrisoli,  Flamma CEO, has been granted Honorary Dalian Citizenship for his friendship to China and his contribution in promoting economic exchanges and cooperation through Flamma Honkai. Negrisoli is the first Italian to receive such Award, the 145^th in city history. Dalian, located in the Liaoning Province, has the largest multi-purpose port in Northeast China and has a population over 7 million people.

Part of the Flamma Group from 2011, Flamma Honkai is a 100% owned and managed facility. Flamma Honkai is part of the fully integrated supply chain (combining Italy, China, and the USA) that Flamma offers its customers.

Flamma Honkai, located in Songmudao Chemical Park, opened its new cGMP workshop, new R&D labs and new QC labs in June 2017. Flamma Honkai will begin construction of a state of the art facility on a new site in 2020 as it continues to be one of most reliable and qualified CDMOs in Asia.

Contact Flamma

Kenneth Drew, Ph.D., Sr. Director, North America Sales and Business Development

1-617-515-0975

The VIPCAT project aims to develop new approaches, through chemical and enzymatic synthesis, for the preparation of aroma and fragrances and active pharmaceutical ingredients (APIs), with high atom economy and green process.

Flamma implements this technology and know-how on its Generic APIs, using Continuous flow chemistry and Solid state techniques through a collaboration with the partnership VIPCAT. This will help to extend its influence in the field of aroma and fragrance synthesis as well as for new synthetic resins for enzyme immobilization.

Chignolo D’Isola, Bergamo, Italy – July 1, 2019 – 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, is proud to announce that the company has acquired the Teva’s Chemical Synthesis Center in Malvern, PA in the Philadelphia area.

“The industry knows and respects the Flamma brand, yet some customers are apprehensive when considering the placement of a project overseas. Flamma understands this and feels that this will be a good option for those wanting to initially start a project close to home,” said Kenneth Drew, Ph.D., Sr. Director of North America Sales and Business Development.

“This facility will be a welcome addition to Flamma’s current customer base as well. Having a US cGMP facility provides further flexibility and options to customers as Flamma continues to grow its R&D teams. Using our unique model of Flamma Academy, we will be able to have R&D chemists from both Italy and China to spend time in the Philly area labs and understand what customers want a first hand. It also helps to bring the entire company together by pairing Italian, Chinese and American scientists together. Flamma is the Thinking CDMO.”

GianMarco Negrisoli, President of Flamma Innovation (the R&D unit within the Flamma Group), noted, “This is another example of the strategic vision for Flamma. The goal is to be recognized by customers as a strategic partner that is ready to invest when and where customers need us to.”

40,000 sq. ft. the facility is in close proximity to Boston/Cambridge (1.5 h flight) as well as the greater New York/New Jersey area (1.5 h drive). Affectionately being dubbed “Flamma-delphia” for now, this extremely well built lab and manufacturing site possesses  a cGMP Pilot Plant with hydrogenation capabilities as well as wet-milling, 6 standard cGMP kilo lab suites, 1 cGMP HPAPI kilo lab suite with isolators that have been classified 3b (Roche) or band 4 (Safebridge), 22 fume hoods, an analytical development lab as well as a QC lab, and additional space for future expansion for any necessary analytical, chemistry, and/or  warehouse needs. Also, the site previously handled controlled drug substances (Schedule II to IV) and Flamma looks forward to reactivating the necessary licenses.

This site will be to be initially dedicated to the development and, production of APIs ranging from pre-clinical/clinical (Phases 1 to 3) and up to commercial phase (after future FDA inspection) with the scale being dependent on the forecasted quantities. Flamma plans to grow the site to 60 employees by 2023 and looks forward to attracting talented personnel

As part of the growing demands of the industry, Flamma has carefully examined various options over the past few years for growth. Flamma felt it was best to start a laboratory operation from the ground floor than try to incorporate an already existing business. By doing this, Flamma can continue to impart its unique culture to its employees from day one and bring value to customers knowing that the same family owned and run culture permeates the new site. This site will be able to quickly accommodate fast-tracked molecules and respond to the constantly growing analytical needs of today’s projects.

This milestone complements the Flamma 2020 Plan to bring value to customers who are looking for a home for their projects and have numerous options to move it forward at the right time. These options include moving projects later on to Flamma’s cGMP facilities in Italy, its cGMP facility in Dalian, China, or taking advantage of both by back integrating the project appropriately. 

This acquisition comes on the heels of the addition of a cGMP workshop at Flamma Honkai and the recent receipt of a cGMP drug manufacturing license from the Chinese FDA. Flamma’s Italian sites also recently added a new cGMP kilo lab as well as a high containment lab to handle genotoxic materials. Flamma intends to invest ~$10M USD to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters soon.

To learn more about Flamma, they will be present at numerous upcoming industry events to discuss its plans. The next event will be CPhI Worldwide in Frankfurt in November 2019.

Contact Flamma

Kenneth Drew, Ph.D., Sr. Director, North America Sales and Business Development

1-617-515-0975

Chignolo D’Isola, Bergamo, Italy – March 20, 2019 – 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, is proud to announce that it has completed the construction of its first cGMP Kilo Lab at its Chignolo D’Isola Headquarters in Italy.

The cGMP Kilo Lab is currently being used for an internal Flamma project in conjunction with its Flow Chemistry Pilot Unit. Meanwhile, customers with projects are reserving production slots for later in 2019.

This investment is part of the Flamma 2020 Plan to bring improvement across its network of manufacturing sites. This addition to the Chignolo site adds another option when working with Flamma’s API site.

GianMarco Negrisoli, Corporate Development Manager at Flamma and CEO of Flamma Innovation, remarked: “The opening of a cGMP kilo lab not only increases capabilities of our facility but also allows our customers greater flexibility in working with Flamma. The ability to place projects in Italy or China and knowing that Flamma is actively managing all our sites is comforting to our customer base.”

Flamma will also begin construction of its new R&D building at our headquarters in Chignolo later this year. “This will quadruple our R&D space thus allowing to continue to grow our staff of researchers to serve the pharma industry and the demands of our current customers as well as future customers,” noted Kenneth Drew, Ph.D., Sr. Director North America Sales and Business Development. “The additional benefit of this addition is the ability to have a fully dedicated analytical building for our growing quality team.”

“Flamma continues to differentiate ourselves from others with our transparency and long-term vision with customers. We are proud to be family owned and run since 1950 since we do not have to answer to demands made from shareholders, private equity groups, or venture capital firms” notes Drew.

To learn more about Flamma, they will be present at numerous upcoming 2019 industry events to discuss its plans. These events include DCAT in New York City in March 2019, CPhI North America in Chicago in April/May 2019 as well as CPhI Worldwide in Frankfurt on November 2019.

Contact: Kenneth Drew, Ph.D.,

Sr. Director, North America Sales and Business Development

Tel: 1-617-515-0975

Chignolo D’Isola, Bergamo, Italy – March 20, 2019 – 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, is proud to announce that Flamma Honkai has passed its first Chinese FDA (CFDA) inspection that took place in December 2018. Part of the Flamma Group, Flamma Honkai is a 100% owned and managed facility in Dalian, China, that is part of the fully integrated supply chain that Flamma can offer customers.

Flamma Honkai opened its new cGMP workshop in June 2017 to continue to address customer desires for more options when it comes to selecting a CDMO that they can trust especially when working overseas in Asia.

This milestone is part of the Flamma 2020 Plan to bring improvement across its network of manufacturing sites. This certification of the Flamma Honkai facility adds another customer option when working with the Flamma Group.

Dr. Gian Paolo Negrisoli, President and CEO of Flamma noted, “This is a strategic and important milestone for Flamma Honkai and Flamma. The efforts made over the past several years have been exceptional.”

“Flamma has been listening to its customers and their need to have a trusted supplier in China,” said Kenneth Drew, Ph.D., Sr. Director of North America Sales and Business Development. “Flamma is unique in our industry by having the ability to provide customers manufacturing of APIs, RSMs, and advanced intermediates from both Europe and China while being led by one management team. Also, with all the consolidation of the CMO industry, being a family-owned, privately held and managed company still brings significant value to our customers. Having that long-term vision continues to differentiate Flamma from other CMOs and CDMOs.”

The Flamma Honkai site comprises two production workshops, supported by a pilot plant, kilo-scale plant and development and analytical laboratories.

Flamma continues to reinvest in itself for the future. In the next two years, Flamma will increase the amount of investments in its three sites. Compared to Flamma’s 2018 Capital Expenditures (CAPEX) which were $15M USD, Flamma intends to invest $20M USD including $9M USD to expand its R&D capabilities with the addition of a new R&D building at its Chignolo d’Isola headquarters.

To learn more about Flamma, they will be present at numerous upcoming 2019 industry events to discuss its plans. These events include DCAT in New York City in March 2019, CPhI North America in Chicago in April/May 2019 as well as CPhI Worldwide in Frankfurt on November 2019.

Contact Flamma

Kenneth Drew, Ph.D., Sr. Director, North America Sales and Business Development

1-617-515-0975

Chignolo D’Isola, Bergamo, Italy – March 9, 2018 – Flamma SpA (“Flamma”), a preeminent Contact Manufacturing Organization (CDMO) that develops, manufactures, and commercializes small-molecule active pharmaceutical ingredients (APIs) for the pharmaceutical industry, is proud to announce that it has been once again awarded the maximum number of available CDMO Leadership Awards for 2018.

Flamma was recognized as a Top Performer for the 3^rd straight year in all 6 CDMO Core Award Categories: Expertise, Reliability, Capabilities, Quality, Service and Compatibility. Flamma averaged a ranking within the top 3 of the 110 contract manufacturers evaluated.

Flamma was also been recognized as a Top Performer in all 7 Specialty Award Categories for the 3^rd straight year. Those specialty categories are: Accessible Senior Management, State-of-the-Art, Innovation, On-Time Delivery, Right the First Time, Strength of Science, and Reputation.

“Flamma has been extremely grateful to be able to work with such a large number of vibrant customers. The entire Flamma team is thankful to be recognized by those who have worked with us and experienced the Flamma difference,” noted Kenneth Drew, Ph.D., Sr. Director North America Sales and Business Development. “Flamma continues to differentiate ourselves from others with our transparency and long term vision with customers. We are proud to be family owned and run since 1950. We do not have to answer to demands made from shareholders, private equity groups, or venture capital firms.”

Dr. Gian Paolo Negrisoli, President and CEO of Flamma remarked, “Flamma has continued to reinvest into ourselves. After the opening of our cGMP workshop at Flamma Honkai, we are also expanding at our Italian sites. We are focusing on containment and the improvement of occupational. We anticipate that later this year we will begin construction of our new R&D building at our headquarters in Chignolo. This will expand our R&D capabilities as well as allow for a dedicated analytical building. We also recently acquired additional land in Dalian that will allow us to build a new state of the art facility at Flamma Honkai.”

Life Science Leader started the CDMO Leadership Awards seven years ago. Industry Standard Research (ISR) conducts the research for Life Science Leader’s CDMO Awards. For the 2018 CDMO Awards data, more than 110 contract manufacturers were evaluated on 23 different performance metrics. Research participants were recruited from pharmaceutical companies of all sizes and were screened for decision-making influence and authority when it comes to working with CDMOs. Respondents only evaluate companies with which they have worked on an outsourced project within the past 18 months. This level of qualification ensures that quality ratings come from actual involvement with a business and that companies identified as leaders are backed by experiential data. This validates these awards to be true and legitimate unlike others. This is the only legitimate industry award based on real data from real decision makers.

Flamma will proudly accept its CDMO Leadership Awards on March 21, 2018 at the reception and ceremony held at the W Hotel in New York City.

Contact: Kenneth Drew, Ph.D.,

Sr. Director, North America Sales and Business Development

Tel: 1-617-515-0975

Chemical and Engineering News (C&EN) did a feature on Flamma that told the story of Flamma and Flamma’s Dalian, China facility- Flamma Honkai.

You can read this article here.