McGuff Pharmaceutical, Inc. Achieves FDA Approval of New Facility
McGuff Pharmaceuticals, Inc. (MPI) is thrilled to announce its recent FDA approval of a new technologically advanced facility at 4040 West Carriage Drive in Santa Ana, Calif. This facility is a state-of-the-art, 86,000-square-foot sterile fill-and-finish pharmaceutical manufacturing plant, which will allow MPI to meet the growing demands of its customers.
Ronald M. McGuff, President of MPI, has been committed to making this a reality. The FDA approval is the result of the dedicated efforts of its employees to acquire, design, construct and validate. It marks another milestone for the company and 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 without investing in additional infrastructure to support it. MPI provides end-to-end, fully integrated drug development and manufacturing solutions and services, including formulation development, product stability, regulatory compliance, clinical trials, quality assurance, and more.
This new facility is designed to meet customer demand for:
- MPI NDA and ANDA labeled injectable products
- Contract manufactured products
- Clinical trial products
“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 McGuff. “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.”
Highlights of the MPI Facility
- Address: 4040 West Carriage Drive, Santa Ana, Calif., 92704
- 86,000 square foot plant
- Sterile fill-and-finish pharmaceutical manufacturing
- Compounding for solutions, emulsions and suspensions
- Current Good Manufacturing Practices (cGMP)
- Sterile and hazardous drugs in 5mL through 100mL vials
- Developed to manufacture high-quality sterile pharmaceuticals in small and large quantities using isolator technology
- Significant Utility capability
- Analytical testing capability
- DSCSA-compliant packaging line
About McGuff Pharmaceuticals, Inc.
McGuff Pharmaceuticals, Inc. (MPI), a division of McGuff Company, Inc. is a family and veteran-owned company based in Santa Ana, Calif. It is an FDA-approved sterile fill manufacturer that maintains a tradition of quality and core competency with current Good Manufacturing Practices.
The McGuff Family of Companies has an over 50-year history of excellence in the pharmaceutical and medical product markets.
About ASCOR® (Ascorbic Acid Injection, USP)
ASCOR® is McGuff Pharmaceuticals Inc.'s branded formula of ascorbic acid injection, USP and is the only FDA-approved formula on the market.
Learn more: www.mcguffpharmaceuticals.com | www.mcguff.com/ASCOR | (800) 854-7220 | pharmaceuticalanswers@mcguff.com.
