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

 

Your CDMO Partner for Complex, Long-Acting Dosage Forms

ProMed Pharma is your distinguished development partner in long-acting injectable and implantable dosage forms. With nearly 20 years of operational history, we have honed our expertise in polymer-based dosage forms, achieving mastery in extended-release dosing. Our proficiency spans molding, extrusion, and microencapsulation techniques, leveraging a diverse spectrum of polymeric excipients encompassing silicones, thermoplastics, and biodegradables. At ProMed Pharma, our commitment to rapid project execution is underpinned by a steadfast dedication to scientific inquiry and technical finesse. Whether you represent an emerging biotech venture or a global pharmaceutical entity, entrust us as your CDMO partner, as we diligently translate scientific concepts into finished dosage forms.

Markets & Applications

Key markets for our services include women’s health, ophthalmology, oncology, and ENT.  Representative drug-device applications include steroid-eluting pacing and defibrillation leads, implantable sensors, antimicrobial eluting devices, and sinus stents.  ProMed also supports pharmaceutical companies developing extended-release formulations utilizing subcutaneous implants, intratumoral pellets, intrauterine devices, intravaginal rings, and ophthalmic inserts. We have over 10 years of history developing and manufacturing PLGA microspheres.

Drug Product Capabilities & Facilities

• Plastic injection molding and hot melt extrusion – bio-material options such as EVA, TPU, PLGA and other biodegradable polymers
• Silicone molding: transfer, liquid injection, insert and compression molding
• Formulation of drug-loaded PLGA microspheres (typically 2-50 micron with excellent size control)
• Experience with steroids, hormones, antibiotics, microbicides, and prostaglandins
• Small molecules, peptides, macromolecules (mAbs, siRNA)
• Micro molding and extrusion of parts as small as 0.1mg, minimum shot size of 100mg
• Design assistance, tooling, molding and assembly, final packaging, and sterilization
• Class 10,000 clean rooms, Class 5 isolators
• More than 10,000 square feet of available manufacturing space for new pharma operations

Quality Control & Quality Assurance

ProMed utilizes both in-house testing and partnerships with state-of-the-art analytical facilities to ensure that drug content, drug elution, purity, mechanical strength, and dimensional specifications are consistently met. The Quality System is compliant to 21 CFR 210/211 and 820 and is ISO13485 certified. ProMed Pharma is registered with the FDA with over 15 years of inspection history.