Provepharm Life Solutions obtains FDA authorization to produce its active ingredients for the United States

Marseille, France, November 29, 2021 – Provepharm Life Solutions, a French private pharmaceutical company that finds new applications for well-known molecules, today announces that it has been granted FDA (Food and Drug Administration) authorization to produce its own Active Pharmaceutical Ingredients (APIs) in order to manufacture drugs for the US market.

Shortly after opening its production plant in 2019, following an inspection by the French National Agency for the Safety of Medicines and Health Products (ANSM), Provepharm was awarded GMP (Good Manufacturing Practice) certification to produce its own active ingredients for European countries. The plant is located at the Château-Gombert technopole in Marseille, France.

In line with its Horizon 2025 strategic plan, Provepharm has also now obtained authorization from the US authorities. This is further evidence of the safety, compliance and excellence of production at Provepharm and will enable the company to produce its first clinical batches more rapidly.

“This FDA authorization allows us to advance a key part of our strategy, which is to increase our independence by taking control of our production. The COVID-19 pandemic has shown how crucial this is, not only for French industry, but on a global scale. By controlling all parts of our supply chain we can now take on our full responsibility as a pharmaceutical company. We are delighted to welcome Damien Holly to support this new stage in our development, which will be crucial to our growth,” said Michel Feraud, CEO of Provepharm Life Solutions.

In summer 2021, Provepharm appointed Damien Holly as Chief Operations and Quality Officer to support the company’s international industrial development. Holly, an Irish chemist, specializes in supply chain management and has run the day-to-day operations at over 40 facilities for companies such as Novartis, Pfizer and Eli Lilly.

“It’s a real honor for me to join Provepharm. I completely subscribe to the project that has been presented to me and I’m certain that my expertise in technical and operational production roles, together with my international experience, puts me in a position to help the group achieve its ambitions for growth,” said Damien Holly.

Provepharm now has the capacity to develop and validate its APIs synthesis. The approved process can then be transferred under license to its industrial partners. The production plant has been operating around the clock for over a year, with highly qualified staff working at the production plant facility to meet increasing client demands.

Provepharm continues to internally develop its product portfolio and is planning a further external growth project in the near future, as it progresses forward on its roadmap.

About Provepharm Life Solutions

Provepharm Life Solutions is a French private pharmaceutical company. With more than 20 years of experience, the company finds new uses for well-known, mature molecules, in particular antidotes and surgical dyes. The company’s historic expertise in fine chemicals provides a platform for redefining purity requirements for active ingredients and maximizing their therapeutic potential, allowing it to explore new and untouched indications. Provepharm’s strategy first bore fruit with the development of a new and patented method for synthesizing methylene blue. This new active ingredient enabled the company to obtain marketing authorizations in over 30 countries and to pursue its expansion internationally.

Founded in 1998 and based in Marseille (France) and Philadelphia (USA), Provepharm Life Solutions has over 90 staff. The company recorded turnover of €48.5 million ($57.5M) in 2020. After raising €42.5 million ($49.8M) in 2019, it received a further investment of €120 million ($142.3M) in September 2021 from Tikehau Capital, which joined its group of historical banking investors, including Société Générale, BNP Paribas, Banque Populaire Méditerranée, Crédit Agricole Alpes Provence and Bpifrance.

www.provepharm.com