GMP Reagents
GMP Reagents
cGMP-manufactured reagents and critical raw materials for pharmaceutical production — with full traceability, regulatory documentation, and change-notification programs.
ISO 13485 Certified Manufacturing
Enzo’s manufacturing facility operates under ISO 13485 quality management with full cGMP compliance. Every GMP reagent is manufactured with complete batch traceability, validated analytical methods, and comprehensive quality documentation to support your regulatory submissions.
- Drug Master Files (DMFs) available for key reagents
- Certificates of Analysis (CoAs) with full analytical characterization
- Change notification program (CNP) for proactive supply chain management
- Stability data and shelf-life documentation
- Regulatory support for FDA, EMA, and global filings
GMP Product Categories
Critical raw materials for pharmaceutical manufacturing
Biochemicals
GMP-grade substrates, cofactors, and small molecules for pharmaceutical formulation and manufacturing.
Enzymes
Validated enzyme preparations for biocatalysis, process chemistry, and quality control testing.
Buffers & Solutions
Pre-formulated and custom buffer solutions manufactured under cGMP conditions.
Reference Standards
Characterized reference materials and controls for assay calibration and method validation.
Excipients
Pharmaceutical-grade excipients with full analytical documentation and regulatory support.
Custom Manufacturing
Scale-up synthesis and custom formulation of GMP reagents to your specifications.
Need GMP-Grade Supply?
Our manufacturing team can provide custom GMP reagents with the documentation package your quality and regulatory teams require.