Edge Pharma produces a wide variety of compounded medications for hospitals, surgery centers, and clinics. Formulations run the gamut from low volume, niche products to high volume medications used by nearly every hospital. As an FDA registered and inspected 503B Outsourcing facility, Edge has the ability to react quickly to customer requirements and deliver cost effective solutions.
USP 795 Nonsterile Compounding
As the 503B leader in USP 795 compliant nonsterile medications, Edge has an entire team devoted solely to these products. Nonsterile formulations from Edge include creams, ointments, gels, solutions, and capsules.
USP 797 Sterile Compounding
Edge Pharma produces sterile compounded medications for a wide array of medical specialties including dermatology, ophthalmology, urology, pulmonology, anesthesiology, allergy, ENT, OB/GYN, and several others. Edge specializes in developing unique and creative solutions to solve compliance challenges.
Within the Edge Pharma facilities, USP 797 and CGMP requirements form the foundation upon which safe production is achieved. Edge helps meet the demands placed on your institution to ensure your medications are in stock when you need them. Safety is built into our processes, giving you confidence that you are providing the best option for patients.
- Edge Pharma follows USP 797 standards and meets CGMP requirements utilizing FDA approved and USP grade components and sterile containers.
- World-class team of scientists, pharmacists, engineers, technicians, and support staff ensure every step of the process, from component intake through final quality check, meets both internal and regulatory standards.
- Full chemistry and microbiology labs, staffed by PhD level scientists, provide support through both the product development process, as well as routine batch testing, for example sterility, potency, and endotoxin.
- Ready-to-use unit doses mean your organization can feel comfortable that safety is the top priority.
- Many of our products are sealed with tamper-evident caps, UV-resistant safety over-wrap bags, and proprietary shrink sleeves for added protection
USP 800 Hazardous Compounding
Edge Pharma specializes in hazardous medications, and in particular develops creative solutions to many of the USP 800 compliance challenges people throughout healthcare are trying to solve. With multiple patent pending products being used by facilities and practitioners across the United States every day, and many more in the pipeline, Edge helps organizations overcome both the preparation and administration components of the regulations. This includes prefilled syringes with pre-attached closed system transfer devices (CSTD), innovative packaging, extended BUD, and consistent supply.
The Emergency Gynecologic Methotrexate injection (mtx injection) from Edge Pharma solves a major issue affecting hospitals and OB/GYN clinics. In facilities without a USP 800 compliant hazardous cleanroom, preparation and administration of Methotrexate is a challenge. With the EmGyn Emergency Gynecologic Methotrexate Kit, any hospital or clinic can now confidently administer adjustable patient-specific body surface area based doses of Methotrexate up to 125mg.
Edge Pharma offers compounded Mitomycin bladder instillation syringe kits that include a 40mg/40mL pre-filled unit-dose syringe of Mitomycin, a closed system transfer device (CSTD), and catheter tip. The CSTD is attached by Edge in an ISO 5 environment according to CGMP. This solution solves the USP 800 hazardous compounding challenge many hospitals and clinics now face when trying to administer Mitomycin. Since the product comes ready-to-administer, you do not need to compound a hazardous drug in your facility.
In addition, Edge Pharma offers compounded Gemcitabine Bladder Instillation Syringe kits. It includes a 1g / 50mL pre-filled unit-dose syringe of Gemcitabine, a closed system transfer device (CSTD), and catheter tip. The CSTD is attached by Edge in an ISO 5 environment according to cGMP. This solution solves the USP 800 hazardous compounding challenge many hospitals and clinics now face when trying to administer Gemcitabine.
Edge Pharma specializes in compounding discontinued, back-ordered, or otherwise unavailable drugs to meet the needs of physicians and patients.
We offer responsive service as we assist you with all of your compounding needs. Our staff is dedicated to excellence and committed to providing you with the highest quality product. It is our goal to create an experience that is always personable and as convenient as possible. Click here for the latest information on drug shortages, as updated by the FDA. Please contact us for more information on how we can help provide many of these vital medications.