3P Biopharmaceuticals receives FDA approval

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.

GMP manufacturing of biologics

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.

Our dedicated team of specialists will be happy to discuss any of your CDMO supply chain needs. Contact us on +34 948 346 480 or email withinus@3pbio.com

Related Content

3P Biopharmaceuticals lands in the United States.

Published: 8th June 2023
The Navarre biological CDMO inaugurates its first commercial office in Boston, supported by Keensight Capital.
Read more

3P Biopharmaceuticals continues its collaboration with U.S. biotech Zhittya for the treatment of Parkinson’s disease.

Published: 2nd May 2023
The process transfer and GMP supply of the FGF-1 candidate have been achieved successfully by both companies.
Read more

The Regional Minister for Economic and Business Development Mikel Irujo meets with the management of 3P Biopharmaceuticals and its majority shareholder Keensight Capital.

Published: 23rd March 2023
During the meeting, attendees evaluated 3P's trajectory and its investment plan for the next five years.
Read more

Get in touch

Let’s discuss your biologics journey.

Discover more about our people, our passion, and how we can work together to improve lives.