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FDA Approves McGuff Pharmaceuticals Facility in Santa Ana, CA

The 86,000-sq.-ft. sterile fill-and-finish manufacturing plant creates new business opportunities in both the CMO and CDMO markets.

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By: Kristin Brooks

Managing Editor, Contract Pharma

McGuff Pharmaceuticals, Inc. (MPI) has received FDA approval of its cGMP facility in Santa Ana, CA. This facility is a state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant.
 
The FDA approval creates new business opportunities in both the Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) marketplaces. 
 
As a CMO/CDMO, MPI helps pharmaceutical companies bring new products or formulas to market. MPI provides end-to-end, fully integrated drug development and manufacturing services, including formulation development, product stability, regulatory compliance, clinical trials, quality assurance, among others.  
 
This new facility is designed to provide MPI NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products, including sterile fill-and-finish pharmaceutical manufacturing, compounding for solutions, emulsions and suspensions, sterile and hazardous drugs in 5mL through 100mL vials, analytical testing, and
DSCSA-compliant packaging.
 
“With this approval, we will increase our production of ASCOR, our FDA-approved Ascorbic Acid Injection (vitamin C injection), ensuring that we meet the growing demands of our customers, both nationally and internationally,” said Ronald M. McGuff, President of MPI. “I wish to extend my heartfelt gratitude to everyone involved in this project for their hard work and commitment. Our employees’ efforts have made this achievement possible, and I am excited about the future it brings.”

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