FLAMMA Announces The Successful CFDA Inspection Of Flamma Honkai

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 in November 2019

About Flamma
FLAMMA is a family owned & run, fully integrated CMO 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 three manufacturing facilities all with R&D labs. 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.

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 550 employees, see why Flamma should be your next contract manufacturer. FLAMMA - THE THINKING CDMO. For more information, visit www.flammagroup.com.