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Pharma GMP Grade EP/USP (API Track)
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
- Pharma GMP zinc oxide (EP / USP compliant)
- API suitability
- Suitable for API development
- Regulatory pathway
- DMF available for direct customer reference, supporting global API registrations
- Regulatory framework
- European Pharmacopoeia alignment
- Pharmaceutical-grade
- Pharmaceutical-grade impurity control
- Regulatory flexibility
- No dependency on CEP-only structures, enabling broader market access
Typical Use
Used in pharmaceutical formulations and active pharmaceutical ingredient (API) applications requiring high purity, traceability and compliance with pharmacopoeia standards.
