PRODUCTS & SERVICES
ProRx Pharma
503B Compounding Pharmacy and Outsourcing Facility
Our Committment
At ProRx, we hold ourselves to the highest standards of quality, safety, and regulatory compliance. From sourcing pharmaceutical-grade ingredients to rigorous batch testing and meticulous documentation, every product is crafted with patient safety and clinical performance at its core. ProRx stands out in the market for its personalized, evidence-based approach to healthcare, particularly in the areas of health, wellness and preventative care.
Why Choose ProRx?
Broad Health and Wellness Product Line
We are dedicated to providing premium compounded medications formulated to support optimal health, wellness, performance, and preventative care. Our offerings are available with bulk shipping to 26 states from our facility and direct-to-patient shipping in all 50 states through ProRx partners.
Comprehensive Quality Assurance
Each compound is tested for sterility, endotoxins, and potency. We maintain rigorous documentation and traceability for every batch and enhanced operational processes that strengthens compliance with compounding lab Standard Operating Procedures (SOPs) and the FDA.
Pharmaceutical-Grade Ingredients
We source only USP-compliant raw materials from FDA-registered suppliers to ensure purity and potency.
Sterile & Non-Sterile Compounding
Our state-of-the-art 6,888-square-foot facility meets or exceeds USP <795> and <797>, for sterile, non-sterile, and hazardous compounding. (<800> pending DEA approval)
Regulatory
Excellence
ProRx operates with full transparency and adheres to all state and federal regulatory guidelines, including FDA, Board of Pharmacy, and State Board of Health protocols
Formulation development
We possess state-of-the-art facilities and extensive expertise to support a wide range of new product development initiatives, ensuring innovative and high-quality outcomes. Our consulting services guide you through every stage of product development, offering strategic insights and technical support. We provide specialized materials for clinical studies, ensuring accurate and reliable trial results. We supply essential materials for physician practices, enhancing patient care and treatment efficacy.
We manufacture a variety of solid dosage forms, including:
- Tablets: Our tablet production capabilities range from immediate-release to controlled-release formulations, ensuring precise dosage and consistency.
- Capsules: We produce both hard and soft gelatin capsules, tailored to meet specific dissolution and release requirements.
- Powders: Our expertise includes the development of bulk powders for reconstitution and direct administration, ensuring optimal stability and efficacy.
Our expertise in disperse systems allows us to produce a wide array of semi-solid products, including:
- Gels: We formulate and manufacture both hydrophilic and hydrophobic gels, optimized for various therapeutic applications and enhanced patient compliance.
- Creams: Our cream formulations are designed for effective delivery of active ingredients, with superior texture and absorption properties.
- Lotions: We develop lotions that provide a balanced delivery of active ingredients while maintaining excellent spreadability and patient comfort.
We are equipped to produce a range of sterile products in various formats:
- Vials: Our vial production includes both single-dose and multi-dose formats, ensuring sterility and stability for injectable medications.
- Bags: We supply sterile IV bags for hospital and clinical use, designed for safe and effective drug delivery.
- Pre-Filled Syringes: Our pre-filled syringe production ensures precision dosing and convenience for both healthcare providers and patients.
We supply placebos for all product types, essential for clinical trials and research studies:
- Tablets, Capsules, and Powders: Matching the appearance and physical properties of active products to ensure blinding in studies.
- Gels, Creams, and Lotions: Formulated to mimic the texture and sensory characteristics of active formulations.
- Sterile Placebos: Provided in vials, bags, and pre-filled syringes, ensuring identical presentation and use conditions to the active products.
Clinical supplies
Providing clinical supplies for phase I-IV is our core strength. We can provide sterile and non-sterile products including tablets, capsules, gels, creams, lotions, injectable, vials, pre-filled syringes, placebo, controlled and extended release formulations in any batch size. All our products are manufactured in compliance with USP specifications and USFDA cGMP requirements and comply with testing requirements for Beyond Use Date labeling.
- Sterile Products: Includes injectables, vials, and pre-filled syringes.
- Non-Sterile Products: Encompasses tablets, capsules, gels, creams, and lotions.
- Specialty Formulations: Availability of placebos, controlled, and extended-release formulations.
- Batch Sizes: We accommodate any batch size, ensuring we meet the specific needs of your clinical trials, whether small-scale or large-scale production.
- USP Specifications: All products are manufactured following the stringent guidelines of the United States Pharmacopeia (USP).
- USFDA cGMP Requirements: Our manufacturing processes comply with the current Good Manufacturing Practice (cGMP) requirements set by the U.S. Food and Drug Administration (USFDA), guaranteeing the highest standards of quality, safety, and efficacy.
- Beyond Use Date Labeling: Our products meet all testing requirements for Beyond Use Date labeling, providing accurate and reliable information on product stability and shelf life.
Clinical trial FDA documentation
Our team is familiar with the information needed for the chemistry and formulation section of clinical trial documents. We can write full protocols for the supply section of clinical trial applications.
Products on drug shortage
Our facility and formulate sterile and non-sterile products currently listed on the USFDA list of drug shortages. This includes a wide range of products based on client needs and market demand.
Enquire Now
We have facility and expertise for a wide range of new product development, consulting for product development, clinical studies materials, and materials for physician practices and pharmaceutical companies.