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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 both nationally and internationally.

McGuff Pharmaceuticals, Inc. (MPI) has announced FDA approval for its cGMP manufacturing facility located in Santa Ana, California. The approval marks a significant milestone for the company, enabling expanded contract manufacturing and development capabilities. The state-of-the-art, 86,000-square-foot facility is designed for sterile fill-and-finish pharmaceutical manufacturing.

Enhanced Manufacturing Capabilities

The FDA's decision opens new avenues for MPI in both the Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) sectors. As a CMO/CDMO, MPI supports pharmaceutical companies in bringing novel products and formulations to market by providing comprehensive, end-to-end drug development and manufacturing services. These services include formulation development, product stability testing, regulatory compliance, clinical trial support, and quality assurance.

Production Expansion

The newly approved facility is equipped to produce MPI's NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial materials. Capabilities include sterile fill-and-finish pharmaceutical manufacturing, compounding for solutions, emulsions, and suspensions, and the handling of both sterile and hazardous drugs in vial sizes ranging from 5mL to 100mL. The facility also offers analytical testing and DSCSA-compliant packaging.

Focus on Ascorbic Acid Injection

Ronald M. McGuff, President of MPI, stated that the approval will allow the company to increase production of ASCOR, its FDA-approved Ascorbic Acid Injection (vitamin C injection). This expansion aims to satisfy the escalating demands of customers in both domestic and international markets. McGuff also expressed gratitude to the employees involved in the project for their dedication and hard work.
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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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