OEM
OEM
White-label and private-label manufacturing solutions backed by Enzo's 40+ years of life science expertise and FDA-registered cGMP facility.
Your Products, Our Expertise
Enzo's OEM program enables diagnostics, pharmaceutical, and biotech companies to bring high-quality products to market under their own brand. We handle manufacturing, quality control, and regulatory documentation while you focus on your core business — serving your customers.
With over four decades of manufacturing experience and FDA-registered facilities, we provide the reliability and quality that your brand demands.
OEM Capabilities
End-to-end solutions for your branded products
Reagent Supply
Bulk reagents, antibodies, substrates, and buffers for integration into your kits and platforms. Available in custom concentrations and formats.
Kit Manufacturing
Complete kit assembly from component manufacturing through final packaging under your brand with lot-to-lot consistency.
Private Labeling
Your branding on our products with custom packaging, product inserts, certificates of analysis, and documentation.
Regulatory Support
Drug Master Files (DMFs), validation data, technical files, and documentation to support your regulatory submissions worldwide.
Quality Assurance
Full QC/QA under our ISO-certified quality system with Certificates of Analysis, stability studies, and release testing for every lot.
Supply Chain
Reliable supply with safety stock programs, demand forecasting, cold chain logistics, and flexible order quantities.
How Our OEM Program Works
Our streamlined OEM process ensures a smooth transition from initial inquiry to production:
- Initial consultation — Define your product requirements, volumes, and timelines
- Feasibility assessment — Our R&D team evaluates technical requirements and provides a detailed proposal
- Development & validation — Custom formulation, packaging design, and method validation
- Pilot production — Small-scale manufacturing run for your review and approval
- Scale-up & production — Full-scale manufacturing with ongoing quality monitoring
- Ongoing supply — Reliable delivery with dedicated account management and technical support
OEM Excellence — By the Numbers
Start Your OEM Partnership
Our business development team can create a customized OEM proposal based on your product requirements and volume needs.