Licensed by the Drug Enforcement Agency (DEA) to handle Schedule I through V drug substances, Mikart has been manufacturing and packaging controlled drug products for over 45 years. The highly regulated controlled substance manufacturing space demands uniquely stringent processes and standards, and our experienced experts help you navigate the exacting controlled substance FDA e-submission.
Our robust facilities are equipped with state-of-the-art security technology and feature over 100,000 cu. ft. of CII vault space, along with cages for CIII-V products — we go above and beyond to ensure the safety and compliance of your controlled substance project.