3P Biopharmaceuticals Receives FDA approval

3P Biopharmaceuticals is a contract development and manufacturing organization (CDMO) specializing in biologic process development and GMP manufacturing. It has received FDA approval after completing a pre-approval Inspection (PAI) at the 3P drug substance manufacturing facility. This approval was completed after the completion of the 3P facility inspection in January 2019.

"To achieve the final approval of the FDA is a great success for a company based in Spain, positioning us at the level of the most distinguished CDMOs in the world," said Dámaso Molero, general manager, 3P Biopharmaceuticals. "This achievement settles a very important breakthrough in the history of 3P and confirms our capacity to tackle the most demanding markets. This certification proves that we are moving forward in the right direction and strengthens our presence in the U.S. market."
 
The U.S. Food and Drug Administration approved 3P Biopharmaceuticals in support of the Calcivis Imaging System PMA P170029 for photoprotein manufacture. The PMA application for the Calcivis Imaging System itself is currently under review by FDA.

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