Custom Synthesis & CMO Services: Scaling Fine Chemicals and APIs from Lab to 6,300L Commercial Batches
At Zhejiang Haizhou Pharmaceutical Co., Ltd. (Established 1970), we support global pharmaceutical and fine chemical companies with custom synthesis, process optimization, and scalable cGMP/non-GMP contract manufacturing.
Operating from our production base in Zhejiang, China, we bridge the gap between initial bench-scale routes and multi-ton commercial production. We combine flexible multi-purpose reactor trains, advanced process safety screening, and a mature global regulatory framework (US FDA, EDQM, NMPA inspections).
Technical Infrastructure & Operational Limits
Our manufacturing site utilizes multi-purpose synthesis shops equipped with stainless steel (316L), glass-lined, and Hastelloy reactors. Below are our standard verified operating windows:
|
Parameter |
Operational Capability |
Facility Details & Equipment |
|
API Reactor Capacity |
50 L to 6,300 L |
Dedicated cGMP lines with closed-system drying and isolation |
|
Intermediate Reactor Capacity |
500 L to 6,300 L |
High-volume glass-lined and stainless steel vessels |
|
Operating Temperature |
-80°C to +250°C |
Cryo-coolers, liquid nitrogen loops, high-temperature thermal oil systems |
|
Operating Pressure |
50 Pa to 5.0 MPa (50 bar) |
High-vacuum fractional distillation columns & pressure reaction vessels |
|
Inert Gas Supply |
~200 m³/h continuous |
High-purity N₂ piping for purging, air-sensitive transfers, and blanketing |
|
Manufacturing Standards |
cGMP and Non-GMP |
Dedicated plant segregation for regulatory and non-regulatory campaigns |
|
In-House Quality Control |
Full analytical suite |
HPLC, GC, Titration, LC-MS, GC-MS, and High-Field NMR |
Specialized Chemical Reaction Capabilities
Rather than using generic synthesis routes, our technical team regularly executes complex, hazardous, or non-standard chemical transformations, including:
Cryogenic Reactions (-80°C)
Organometallic reactions, selective lithiations, and asymmetric reductions.
High-Pressure Gas Chemistry (up to 5 MPa)
Catalytic hydrogenations, carbonylation, and high-pressure amination.
Corrosive & Thermal Reactions (up to 250°C)
High-temperature cyclizations, halogenations, and acid-catalyzed condensed chemistry.
High-Vacuum Fractional Distillation (down to 50 Pa)
Separation of thermally labile intermediates and close-boiling isomer mixtures.
From Tech Transfer to Commercial Execution
Every custom synthesis campaign undergoes rigorous engineering, thermal risk evaluation, and quality planning before entering production.
Process Safety Assessment & Route Review
Before introducing a compound to plant equipment, our lab screens the chemistry using Differential Scanning Calorimetry (DSC) and reaction calorimetry (RC1). We establish heat-accumulation profiles, gas evolution rates, and runaway reaction thresholds to ensure plant-scale safety.
Process Optimization & Solvent Recycling
We refine bench-scale procedures to increase volumetric productivity and eliminate plant bottlenecks:
- Replacing hazardous or toxic reagents with greener, commercially viable alternatives.
- Establishing optimal crystallizing parameters (seed addition rates, cooling curves) to control particle size distribution (PSD).
- Designing solvent recovery loops directly into the batch process to lower raw material expenditure.
Engineering Scale-Up & Pilot Campaigns
Scale-up is managed through our intermediate-scale reactor train (50 L to 500 L). Engineers calculate mass transfer rates, agitation dynamics, heat transfer surface areas, and solid-liquid isolation behavior to prevent yield drops during full-scale transfers.
Commercial Manufacturing & Quality Release
Commercial campaigns (up to 6,300 L) run under fully traceable Master Batch Records (MBR). In-Process Controls (IPC) track conversions at every key stage, followed by thorough quality control release testing.
Quality Assurance & Global Regulatory Compliance
Securing international commercial filings requires full compliance transparency. Haizhou Pharma's quality management systems are designed to support target market registrations in Europe, North America, and Asia.
Regulatory Audits & Compliance
Production processes operate aligned with cGMP guidance. Our site maintains an audit history supporting inspections and documentation for the US FDA, EDQM, and NMPA.
System Certifications
ISO 9001:2015 (Quality) and ISO 14001:2015 (Environmental Management).
Filing & Regulatory Support
We provide comprehensive documentation packages, including Drug Master File (DMF) technical packages, stability data (ICH conditions), process validation reports, and full Certificates of Analysis (CoA).
Analytical Development & Quality Control Operations
Quality control is integrated into every step of process development and manufacturing. Our on-site analytical laboratories utilize:
HPLC & GC
Purity determination, related substance profiling, and residual solvent quantification (Headspace GC).
LC-MS & GC-MS
Impurity identification, structural elucidation, and degradant isolation.
High-Field NMR
Direct structural verification for novel intermediates and key synthetic steps.
Wet Chemistry & Physical Testing
Titrations, Karl Fischer moisture measurement, loss on drying, particle size analysis, and residue on ignition.
Project Governance & Data Confidentiality
Protecting customer Intellectual Property (IP) is a fundamental condition of our business.
Bilateral NDAs
Mutual non-disclosure agreements are established before sharing synthetic routes, target structures, or operational specifications.
Dedicated Project Management
A dedicated technical project manager serves as a single point of contact, providing weekly batch progress reports, IPC data trends, and updated production schedules.
Technical Information Required for Inquiry Evaluation
To assist our R&D and engineering teams in providing a fast, accurate technical feasibility review and cost estimate, please provide the following details:
Target Molecule
CAS number, chemical structure, molecular weight, or IUPAC name.
Material Specifications
Target purity (HPLC/GC), allowable impurity profile, particle size requirements, and physical form.
Volume & Timeline
Initial pilot volume requirement, expected annual commercial demand, and target delivery dates.
Technical FAQ
Ready to evaluate your compound for scale-up?
Submit your technical specifications or route details to our technical team for a preliminary feasibility assessment under NDA.
[Submit Your Project] [Talk to Our Technical Team]