ProRx Pharma

ProRx Pharma is a leading FDA-registered cGMP facility specialising in pharmaceutical outsourcing and testing services.

Situated in Exton, Pennsylvania, ProRx Pharma is strategically located near clinical centres, hospitals, and pharmaceutical companies. The company is dedicated to supplying high-quality clinical trial materials and addressing the demand for medications listed on the FDA drug shortage list. Additionally, ProRx offers customised products and formulations tailored for institutions and physician offices.

Key Products and Services:

• Pharmaceutical Testing: Comprehensive testing services for products from pharmacies, hospital Investigational Drug Services (IDS), and pharmaceutical companies, including formulation testing, certificates of analysis (COA), stability testing, Beyond Use Date (BUD) studies, and life-cycle extension.

• Formulation Development: Expertise in developing a wide range of products such as solid dosage forms (tablets, capsules, powders), disperse systems (gels, creams, lotions), sterile products (vials, bags, pre-filled syringes), and placebos. Capabilities also include lipid-based formulations and controlled-release systems.

• Clinical Supplies: Provision of sterile and non-sterile products for Phase I-IV clinical trials, including tablets, capsules, gels, creams, lotions, injectables, vials, pre-filled syringes, placebos, and controlled and extended-release formulations, accommodating any batch size. All products comply with USP specifications and USFDA cGMP requirements, meeting testing standards for Beyond Use Date labelling.

• Clinical Trial FDA Documentation: Assistance in preparing the chemistry and formulation sections of clinical trial documents, including drafting full protocols for the supply section of clinical trial applications.

• Products on Drug Shortage: Capability to formulate sterile and non-sterile products currently listed on the USFDA drug shortage list, addressing client needs and market demand.

With a mission to supply high-quality pharmaceutical products supporting drug shortages and clinical research, ProRx Pharma combines extensive knowledge in pharmaceutical compounding with experience in clinical study requirements. Their team of seasoned researchers, including members from academia, the pharmaceutical industry, and licensed pharmacists, is committed to delivering cost-effective solutions promptly, ensuring successful clinical trials and improved patient care.