11/22/2019

FLAMMA CEO given Chinese Citizenship for business efforts in China

Chignolo D’Isola, Bergamo, Italy – November 21, 20...

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FLAMMA CEO given Chinese Citizenship for business efforts in China

11/22/2019

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 145th 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

07/01/2019

FLAMMA acquires Teva’s Philadelphia cGMP facility marking entry into the US marketplace with labs & pilot plant

Chignolo D’Isola, Bergamo, Italy – July 1, 2019 – ...

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FLAMMA acquires Teva’s Philadelphia cGMP facility marking entry into the US marketplace with labs & pilot plant

07/01/2019

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

03/20/2019

FLAMMA announces the successful CFDA inspection of Flamma Honkai

Chignolo D’Isola, Bergamo, Italy – March 20, 2019 ...

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FLAMMA announces the successful CFDA inspection of Flamma Honkai

06/19/2019

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

03/20/2019

FLAMMA Opens New cGMP Kilo Lab Suite in Italy and plans construction of new R&D building

Chignolo D’Isola, Bergamo, Italy – March 20, 2019 ...

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FLAMMA Opens New cGMP Kilo Lab Suite in Italy and plans construction of new R&D building

06/18/2019

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

12/02/2019

FLAMMA sweeps 2018 CDMO Leadership Awards for the 3rd year in a row

Chignolo D’Isola, Bergamo, Italy – March 9, 2018 –...

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FLAMMA sweeps 2018 CDMO Leadership Awards for the 3rd year in a row

06/18/2019

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 3rd 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 3rd 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