Applicable sections of 21 CFR 210 & 211
Exceptional inspection history
COLLABERATION. INTEGRIRTY. OPENESS.
These are the qualities we believe in and practice every day. The result is a commitment to our consumers that delivers effective and superior services. Every day. For Life.
The ProMed Pharma Story
Leveraging historical expertise in a molded implantable components, ProMed Pharma develops and manufactures polymer-based drug-releasing implants and combination device components. Working with both established and early-stage medical device and pharmaceutical companies, we develop robust processes and platforms for controlled release of drugs from a variety of materials.
DRUG PRODUCT CAPABILITIES AND FACILITIES
- Silicone molding – transfer, liquid injection, insert, and compression molding
- Plastic injection molding – materials include ethylene vinyl acetate (EVA), polyurethane (PU), and poly (lactide co-glycolide) (PLGA)
- Experience with steroids, hormones, antibiotics, microbicides, and postaglandins
- Micro molding of parts as small as .001g, minimum short size of .05g
- Dedicated presses and mizing equipment for pharmaceutical products
- Class 10,000 clean rooms, Class 5 isolators
- More than 10,000 square feet of available manufacturing space for new pharma operations
- ProMed has state-of-the-art analytical facilities for:
- Drug assay, impurities, and content uniformity
- In vito drug release
- Mechanical testing and surface/dimensional characterization
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