Established in 1993, Powdersize is a privately held company with the vision to “set the benchmark” in the cGMP marketplace, Powdersize focuses on the micronization of active pharmaceutical ingredients (API’s) and excipients by providing processing suites with suitable cross contamination controls; jet mills of proprietary and sanitary design and robust quality and cleaning protocols.
Within the first year of company operation, the plant was registered and approved by the FDA to process pharmaceutical drug substances and food grade materials. Routine FDA audits approximately every 2 years since, have resulted in an exemplary record of regulatory compliance. This in turn provides our customers with confidence that the purity, identity and strength of their pharmaceutical powders will be maintained during our cGMP processing.
Over the years, micronization capacity has been expanded to include the ability to process all scales of product development (R&D/Clinical/Commercial). More recently, capabilities to process high potency compounds and controlled substances have been added to keep pace with the growing industry demand in these marketplaces.