3P Biopharmaceuticals, a contract development and manufacturing organization (CDMO) specialized in process development and GMP manufacturing of biologics, has received FDA
approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility. This approval comes after completing the inspection conducted at 3P facilities during 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.