ProRx Pharma, a cGMP-certified 503B outsourcing facility, has announced a significant expansion of its manufacturing operations to address the growing demand for essential compounded medications. The expansion project will double the company's existing facility size to 6,888 square feet, enabling a threefold increase in manufacturing capabilities.
Strategic Facility Expansion and Enhanced Compliance
The enlarged facility represents a major step forward in ProRx's commitment to addressing critical drug shortages. The additional production space will not only increase output but also enhance operational processes, strengthening compliance with compounding lab Standard Operating Procedures (SOPs) and FDA requirements.
Leadership Enhancement and Quality Focus
As part of its strategic rebranding initiative, ProRx has made significant additions to its executive team. The company has appointed a new Vice President of Clinical Operations, bringing 40 years of comprehensive compounding experience across both 503A and 503B sectors. Additionally, a new head of Quality Assurance has been installed to oversee compliance and product safety measures.
To further strengthen its regulatory compliance framework, ProRx has established a partnership with an FDA compliance consulting firm that brings over 25 years of specialized industry experience in FDA interactions.
Expanding Market Presence and Services
Currently, ProRx maintains licenses to provide compounded medications in 25 states, with plans for rapid expansion. The company's service portfolio extends beyond manufacturing drugs on the FDA shortage list to include:
- Pharmaceutical testing
- Formulation development
- Clinical supplies
- Clinical trial FDA documentation
Kurt Lunkwitz, Chief Operating Officer at ProRx, emphasized the company's critical role in healthcare: "Compounding pharmacies play a critical role in the healthcare ecosystem in terms of meeting patients' demands for more accessible and affordable medications." He added, "The new leadership team at ProRx not only has a wealth of industry experience, but also a shared vision for the company's future. The addition of these talented professionals means we will continue to be a 'disruptor' and redefine what it means to be a leader in the 503B pharmaceutical sector while staying firmly committed to exceeding the standards that are set by our industry."
