Strukmyer, LLC

Strukmyer, a cutting-edge medical manufacturing firm, specializes exclusively in contract manufacturing of Converting (Primary, Secondary & Advanced Wound Dressings), Compounding (liquids, powders, creams & Gels), & Collagen (medical, surgical & dental) products. Renowned for its expertise in high-volume custom production runs, patented products, and FDA 510K required items, Strukmyer offers a comprehensive range of services from R&D, design, engineering, and global sourcing to packaging, sterilization, and regulatory compliance. With FDA Drug and Device registration, ISO 13485:2016 certification, DEA and FDA registration for drug compounding (503b), and adherence to cGMP standards, Strukmyer ensures the highest quality standards are met. Equipped with Controlled Manufacturing Environments (CME) and ISO Class 7 and Class 8 clean rooms, the company excels in pharmaceutical compounding, converting, packaging, and filling operations. Established in 1980 under the name Struckmeyer Corporation, Strukmyer boasts ownership of several 510k products, demonstrating its commitment to rapid and safe product development. With a deep understanding of FDA regulatory requirements and a focus on patient safety, Strukmyer serves as a trusted partner for clients across various sectors, including hospital, OTC, nutritional, and consumer industries.