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.
