Flamma SpA, a contract development and manufacturing organization (CDMO) that develops, manufactures, and commercializes small molecule active pharmaceutical ingredients (APIs) for the pharmaceutical industry, said 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 Flamma’s fully integrated supply chain.
 
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.
 
“This is a strategic and important milestone for Flamma Honkai and Flamma,” said Gian Paolo Negrisoli, president and chief executive officer, Flamma. “The efforts made over the past several years have been exceptional.”
 
Kenneth Drew, senior director of North America sales and business development, Flamm, said, “Flamma has been listening to its customers and their need to have a trusted supplier in China. 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.