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FDA classified 3P facilities as acceptable for manufacture of target molecule, and appropriate for commercialization in the US once product is authorized
September 18, 2019
By: Tim Wright
Editor-in-Chief, Contract Pharma
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...
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