Aptar CSP Technologies provides regulatory compliance and support to meet the needs of our customers in the pharmaceutical, medical device, diagnostics, and food products industries with strict adherence to regulatory guidelines. We provide comprehensive regulatory support, to ensure our solutions comply with regulatory requirements.
Aptar CSP Technologies manufacturing plants meet requirements set forth by the U.S. Food and Drug Administration (FDA) and are compliant with the FDA’s Current Good Manufacturing Practice (cGMP) regulations. Our proprietary three-phase Activ-PolymerTM formulations are included in a Drug Master File (DMF #14789). Aptar CSP’s plants only use materials for manufacturing products that are Generally Recognized as Safe (GRAS). Production is completed under Good Manufacturing Practices (GMPs).