Zinc Oxide Pharma GMP EP/USP (API Track)

API supported zinc oxide for API applications

High purity zinc oxide produced under GMP conditions, compliant with Ph. Eur. / USP monographs and aligned with ICH Q7, supporting pharmaceutical applications through an open DMF approach.

Positioning

Designed for pharmaceutical applications requiring GMP-controlled production and full regulatory transparency.
Supports API registration via an open DMF structure, enabling direct customer access and faster dossier integration.

Technical Specifications

Purity Range

99.0 – 100.5 % (Ph. Eur. / USP)

GMP

GMP manufactured under controlled conditions

Compliant

EP / USP compliant zinc oxide

Suitable

Suitable for API development

Regelatory

API pathway compatibility (EDQM)

Typical Use

Used in pharmaceutical formulations, dermatological preparations and other regulated healthcare applications where high purity, traceability and compliance are essential.