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3P Biopharmaceuticals receives FDA approval

3P Biopharmaceuticals

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

[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), 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.

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About 3P Biopharmaceuticals

3P Biopharmaceuticals is a leading CDMO specialized in process development and GMP manufacturing of biologics and cell therapy products. 3P offers solutions at all stages of biologics development, from initial process and analytics development to preclinical and clinical phases and commercial production. Its extensive experience, flexibility, and adaptation, as well as its innovative technology and qualified team, have made 3P an example for the international market.

Further information: http://www.3pbio.com/

About CALCIVIS

CALCIVIS is an innovative medical devices company focused on revolutionising the management of dental caries or ‘tooth decay’. CALCIVIS brings together novel biotechnology approaches and world-class device development expertise and is at the forefront of applying biotechnology to dentistry. The CALCIVIS imaging system will, for the first time, allow the real-time detection and visualisation of calcium ions released by demineralising caries lesions in routine dental practice. CALCIVIS began operations in 2012 and is based in Edinburgh, Scotland.

Further information: http://www.calcivis.com/

About FDA

FDA stands for the Food and Drug Administration, the USA government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products, and tobacco products being sold or manufactured in the United States. The FDA also inspects and enforces regulations related to these industries.

Further information: https://www.fda.gov/

3P Biopharmaceuticals press contact:
Isabel García
Communications and Marketing Responsible at 3P Biopharmaceuticals
Tlf: + 34 948 346 480
email: igarcia@3pbio.com
web https://www.3pbio.com/
 
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