ProMed Pharma, LLC
15600 Medina Road
Minneapolis, MN 55447
T: (763) 331-3800
F: (763) 331-3888
E: info@ promedpharmallc.com
W: www.promedpharmallc.com

 

For over 20 years, ProMed Molded Products has specialized in the molding of small, intricately designed silicone components and sub-assemblies. In 2006, ProMed Pharma leveraged this expertise to begin production of polymer-based drug-releasing implants and combination device components. Working with both established and early stage medical device and pharmaceutical companies, ProMed develops robust manufacturing processes and platforms for controlled release of drugs from a variety of materials.

Key markets for our services include cardiovascular, neurology, and ophthalmology. Representative drug-device applications include steroid-eluting pacing leads, drug-eluting stents and balloons, and antimicrobial catheters.  ProMed also supports pharmaceutical companies developing extended release formulations utilizing subcutaneous implants, intrauterine devices, intravaginal rings, and ophthalmic implants.

Specific capabilities include:

– Silicone molding – transfer, liquid injection, insert and compression molding
– Plastic injection molding and extrusion – biomaterial options such as ethylene vinyl acetate (EVA), polyurethanes, and poly (lactide co-glycolide) (PLGA)
– Experience with steroids, hormones, antibiotics, and microbicides
– Micro molding of parts as small as 0.1 mg
– Design assistance, rapid prototype tooling, molding, and assembly
– Dedicated processing and mixing equipment for APIs
– Class 10,000 clean rooms, Class 5 isolator
– More than 10,000 square feet of available manufacturing space for new manufacturing operations

ProMed utilizes both in-house anlaytical testing and partnerships with state-of-the-art facilities to ensure that drug content, drug elution, purity, mechanical strength, and dimensional specifications are consistently met. ProMed Pharma’s Quality Assurance is dedicated to delivering drug-eluting components of the highest quality that can be used in implantable pharmaceutical products and life- sustaining medical devices. Our Quality System was designed using the 21 CFR 820 Quality System Model and supplemented with applicable sections of the Pharma cGMPs. ProMed Pharma is ISO13485 certified and FDA registered and inspected.