Regional Regulatory Filings

Regulatory Filings

Drug Master File (FDA): 

UltraGRO™-PURE GI, UltraGRO™-PURE, and UltraGRO™-Advanced each have a Type II Drug Master File (DMF) with the FDA. Please contact sales@atcbiomed.com for further information.

 

European Pharmacopoeia General Chapter 5.2.12.4 (EMA): 

UltraGRO™-PURE GI and UltraGRO™-Advanced GI have been manufactured under GMP in compliance with European Pharmacopoeia General Chapter 5.2.12.4 guidance.

 

Pharmaceuticals and Medical Devices Agency (PMDA):

UltraGRO™-PURE GI and UltraGRO™-Advanced GI have received a Japan PMDA Certificate.