McGuff Pharmaceuticals Achieves FDA Approval for New Santa Ana Facility

/ News, Orange County / By

In a significant development for the pharmaceutical industry, McGuff Pharmaceuticals, Inc. (MPI) has received FDA approval for its new state-of-the-art facility located in Santa Ana, California. This 86,000-square-foot sterile fill-and-finish manufacturing plant is set to enhance the company’s production capabilities and expand its presence in the Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) markets.

A Boost for Local Pharmaceutical Manufacturing

The approval of the Santa Ana facility represents a major achievement for MPI, which has been committed to expanding its capacity and maintaining high standards of quality. The facility, located at 4040 West Carriage Drive, is designed to meet the growing demand for sterile pharmaceutical products. It will manufacture a wide range of injectable solutions, including MPI’s FDA-approved ASCOR® (Ascorbic Acid Injection), catering to both national and international markets.

Advanced Capabilities and Technology

The Santa Ana facility is equipped with cutting-edge technology, meeting the Current Good Manufacturing Practices (cGMP) standards required by the FDA. Key features include:

  • Isolator technology: Ensuring the highest levels of sterility for compounding solutions, emulsions, and suspensions.
  • Analytical testing: Providing in-house testing capabilities to maintain quality control.
  • DSCSA-compliant packaging line: Supporting compliance with the Drug Supply Chain Security Act, ensuring the safety and traceability of pharmaceutical products.

This investment demonstrates MPI’s commitment to quality and innovation, which has been a cornerstone of the company’s operations for over 50 years. By expanding its capabilities in Orange County, MPI is poised to address both current and future needs of healthcare providers, offering scalable solutions to support clinical trials, regulatory compliance, and commercial production.

Expanding Opportunities in the CMO/CDMO Markets

The new facility not only increases MPI’s capacity but also opens new opportunities in the CMO/CDMO sectors. By providing end-to-end drug development and manufacturing solutions, MPI enables pharmaceutical companies to bring new products to market without the need for additional infrastructure. From formulation development to quality assurance, the company offers a comprehensive range of services designed to support pharmaceutical innovation.

What This Means for Orange County

For Santa Ana and the surrounding areas, this FDA approval signifies more than just an increase in manufacturing capabilities. It represents job creation, economic growth, and an expansion of the local healthcare sector. As MPI grows, it will likely bring more skilled jobs to Orange County, reinforcing the region’s position as a hub for healthcare and pharmaceutical innovation.

A Vision for the Future

Ronald M. McGuff, President of MPI, expressed his gratitude for the efforts of his team, stating, “With this approval, we will increase our production of ASCOR® and meet the growing demands of our customers, both nationally and internationally.” The achievement marks another milestone for McGuff Pharmaceuticals and sets the stage for future growth.

As MPI looks ahead, the Santa Ana facility serves as a foundation for continued expansion and excellence in pharmaceutical manufacturing, providing essential products that contribute to healthcare advancements across the U.S. and beyond.

To learn more about McGuff Pharmaceuticals and its new facility, visit McGuff Pharmaceuticals.

/