Provepharm obtains FDA approval to supply APIs in the US

30-Nov-2021

The development follows recent authorisation from the ANSM to provide active ingredients in European countries

Image credit: Provepharm

Provepharm Life Solutions, a French private pharmaceutical company, has been granted FDA (Food and Drug Administration) authorisation to produce its own 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), the company was awarded GMP certification to produce active ingredients for European countries. The plant is located at the Château-Gombert technopole in Marseille, France.

The company has now also obtained authorisation from the US authorities, which it says is further evidence of the safety and compliance of production at the facility.

“This FDA authorisation 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 specialises in supply chain management and has run the day-to-day operations at more than 40 facilities for companies such as Novartis, Pfizer and Eli Lilly.

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“It’s a real honour 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.

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