ProRx Pharma, a cGMP, 503B outsourcing facility focused on providing essential compounded medications, has expanded its operations to help meet the demand for critical medications.

The company specializes in manufacturing products on the FDA’s drug shortage list, offering medications to clinical centers, hospitals and pharmaceutical companies. ProRx is currently expanding its operations to a total of 6,888 sq.-ft., doubling its existing pharmaceutical and manufacturing facility. The new facility with more production space will allow ProRx to triple its manufacturing capabilities and enhance operational processes that will further strengthen compliance with compounding lab Standard Operating Procedures (SOPs) and the FDA.

As part of its strategic rebranding and expansion under new leadership, ProRx has made additions to its operations team, including a new Vice President of Clinical Operations, with 40 years of compounding experience across both 503A and 503B sectors, and a new head of its Quality Assurance unit, with expertise in compliance and product safety. 

Additionally, ProRx has partnered with an FDA compliance consulting firm, bringing more than 25 years of proprietary industry experience working directly with the FDA. 

ProRx is an FDA-registered cGMP facility and is currently licensed to provide compounded medications in 25 states and rapidly expanding coverage. In addition to manufacturing drugs on the FDA shortage list, the company offers pharmaceutical testing, formulation development, clinical supplies, and clinical trial FDA documentation.

“Compounding pharmacies play a critical role in the healthcare ecosystem in terms of meeting patients’ demands for more accessible and affordable medications,” said Kurt Lunkwitz, Chief Operating Officer at ProRx. “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.”