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McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility

• McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA. • The FDA approval allows MPI to expand its capabilities as a CMO/CDMO, offering integrated drug development and manufacturing services to pharmaceutical companies. • The new facility will support the production of NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products, including sterile and hazardous drugs. • MPI plans to increase production of its FDA-approved Ascorbic Acid Injection (ASCOR) to meet growing customer demands following the facility's approval.

McGuff Pharmaceuticals, Inc. (MPI) has announced FDA approval of its current good manufacturing practice (cGMP) facility located in Santa Ana, California. The approval marks a significant milestone for the company, enabling expanded manufacturing capabilities and new business opportunities in the contract manufacturing organization (CMO) and contract development and manufacturing organization (CDMO) sectors.
The Santa Ana facility is an 86,000-square-foot, state-of-the-art plant designed for sterile fill-and-finish pharmaceutical manufacturing. This facility is equipped to handle a wide range of services, including formulation development, product stability testing, regulatory compliance, clinical trials support, and quality assurance.

Enhanced Manufacturing Capabilities

As a CMO/CDMO, MPI supports pharmaceutical companies in bringing new products to market. The newly approved facility will produce NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products. These include sterile fill-and-finish pharmaceutical manufacturing, compounding for solutions, emulsions, and suspensions, and the handling of both sterile and hazardous drugs in 5mL to 100mL vials. The facility also offers analytical testing and Drug Supply Chain Security Act (DSCSA)-compliant packaging.

Increased Production of ASCOR

"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. The company anticipates that the FDA approval will significantly boost its ability to meet market demands for its products.

Future Outlook

MPI views the FDA approval as a pivotal moment, highlighting the hard work and commitment of its employees. The company is optimistic about the future and the opportunities this approval creates for growth and innovation in pharmaceutical manufacturing.
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Reference News

[1]
FDA Approves McGuff Pharmaceuticals Facility In Santa Ana, CA | Contract Pharma
contractpharma.com · Oct 31, 2024

McGuff Pharmaceuticals, Inc. (MPI) received FDA approval for its 86,000-sq.-ft. sterile fill-and-finish facility in Sant...

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