The FDA classified 3P facilities as acceptable for the manufacture of the target molecule, and appropriate for its commercialization in the US market, once the product is authorized.
3P Biopharmaceuticals a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
The U.S. Food and Drug Administration (FDA) is the agency responsible for protecting and promoting Public Health. According to high-quality standards, the FDA approves a drug after evaluating whether the methods and facilities used for its manufacturing are adequate to ensure and preserve the drug’s identity, strength, quality, and purity. This approval comes after completing the inspection conducted at 3P facilities during January 2019.
Therefore, in the opinion of Dámaso Molero, General Manager at 3P Biopharmaceuticals, this is a significant milestone for the company and “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. This achievement settles a very important breakthrough in the history of 3P and confirms our capacity to tackle the most demanding markets”.
He also added, “this certification proves that we are moving forward in the right direction and strengthens our presence in the USA market, which allows us to accomplish one of our strategic company goals.”
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.