Custom Synthesis | Regulatory Support | Global Export
Chemzen International FZ LLC is a cGMP-certified contract development and
manufacturing organization (CDMO) specializing in the custom synthesis of:
- High-Purity APIs (ICH Q7 compliant, up to 99.9% purity)
- Advanced Intermediates (including chiral, halogenated, and heterocyclic
compounds) - Niche Specialty Chemicals (for catalysis, formulation, and drug delivery systems)
Our facilities are equipped for multi-kilogram to metric ton-scale production, supporting
clients from preclinical development to commercial supply.
Our Innovations
Technical Capabilities
API & Intermediate Manufacturing
- Therapeutic Focus: Oncology, CNS, Cardiovascular, Anti-infectives
- Chemical Expertise:
- Potent compounds (OEB 4-5, <1 μg/m³ exposure control)
- Highly hazardous chemistry (nitrations, azide, Grignard, etc.)
- Continuous flow chemistry for improved selectivity/yield
- Purification: Crystallization, chromatography (prep-HPLC), d
Specialty Chemical Synthesis
- Custom ligands, catalysts, and reagents (e.g., boronic acids, PEG derivatives)
- Isotope-labeled compounds (²H, ¹³C, ¹⁵N)
- High-energy materials (controlled conditions for peroxide/formers)
Analytical & Quality Control
- In-House Testing:
- HPLC/UPLC (ICH Q2(R1) validated methods)
- GC, LC-MS, NMR (¹H/¹³C)
- Karl Fischer, DSC, XRD for polymorph screening
- Specifications: Meets USP/EP/JP monographs or client-defined criteria
Scale-Up Expertise
- Pilot Plant: 50L–500L reactors (glass-lined, Hastelloy)
- Safety: ATEX-compliant facilities for hydrogenation/pyrophorics
- Process Optimization: DoE (Design of Experiments) for critical parameters
Regulatory Compliance
- Facility Standards:
- cGMP (FDA/EMA compliant)
- ISO 9001:2015 certified
- Schedule D & WHO-GMP for export markets
- Documentation Support:
- DMFs (Type II & III)
- CMC packages for ANDA/IND filings
- Impurity profiling (ICH M7, Q3A/B)
Industries Served
| Segment | Applications |
|---|---|
| Generic Pharma | Non-infringing API routes, patent bypass |
| Biotech | Preclinical candidates, orphan drugs |
| CROs | Reference standards, metabolites |
| Agrochem | Custom synthons for crop protection |
Why Partner With Us?
Flexible Synthesis Routes: >80% projects use novel, cost-efficient pathways
IP Protection: Secure data rooms, NDAs, and patent-aware chemists
Supply Chain Resilience: Dual sourcing, cold chain logistics (2–8°C, -20°C)
Turnaround Time: Lab-scale: 4–8 weeks
Commercial batches: 12–16 weeks (depending on complexity)
Looking for a technically audited supplier? OR Schedule a Facility Tour.
Email us - info@chemzeninternational.com
Required Details for RFQ
- Structure/CAS number
- Target quantity (mg to kg)
- Purity/impurity profile
- Regulatory needs (e.g., GMP, research-grade)