China Manufacturing Landscape for Mirtazapine (CAS 85650-52-8)
Mirtazapine, the tetracyclic antidepressant acting as a noradrenergic and specific serotonergic agent (NaSSA), is manufactured at scale across several Chinese production facilities. Our cproduction plant in Shandong Province is one of the largest dedicated Mirtazapine API producers in China, with a track record of supplying major generic pharmaceutical companies across the EU, North America, and Asia-Pacific regions. As a direct manufacturer, we offer transparent supply chain visibility and competitive pricing.
The Chinese pharmaceutical API industry has matured significantly in quality infrastructure, and our facility reflects this evolution. Successful regulatory inspections by the EU QP system, Korea MFDS, and multiple WHO prequalification audits validate our manufacturing standards. Our Mirtazapine production benefits from established supply chains for starting materials and intermediates, with multiple qualified sources for each critical input.
Manufacturing Process & Facility
Our Mirtazapine synthesis follows a validated multi-step chemical process starting from 2-chloronicotinic acid derivatives. The synthesis route features a key ring-closure step forming the characteristic piperazino-azepine core structure, followed by catalytic hydrogenation and final purification through recrystallization. The racemic mixture is produced to pharmacopeial specifications with controlled impurity profiles.
Facility specifications:
- 25,000 m² total facility with 8,000 m² dedicated quality-controlled production area
- Glass-lined reactors from 500L to 6,000L with automated temperature and pressure control
- Dedicated hydrogenation suite with fixed-bed catalytic reactors and hydrogen safety systems
- ISO Class 8 processing and ISO Class 7 packaging cleanroom environments
- Annual production capacity: 50 metric tons of Mirtazapine API
- Fully automated DCS (Distributed Control System) for all production operations
Continuous process improvement initiatives have increased our overall yield by 15% over the past three years while simultaneously reducing solvent consumption per kilogram of API produced.
Quality Standards & Multi-Pharmacopeial Compliance
Our Mirtazapine API is manufactured and tested to simultaneously meet USP, EP, and BP monograph requirements:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to creamy white powder | Visual |
| Identification | Positive by IR, HPLC, melting point | IR/HPLC/DSC |
| Assay (dried basis) | 99.0–101.0% | HPLC |
| Related Substances (total) | ≤0.5% | HPLC |
| Any Single Impurity | ≤0.10% | HPLC |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Elemental Impurities | Meets ICH Q3D | ICP-MS |
| Loss on Drying | ≤0.5% | 105°C, 2h |
| Sulphated Ash | ≤0.1% | Gravimetric |
| Particle Size (D90) | Per customer spec (micronized available) | Laser diffraction |
Regulatory Documentation
Our Mirtazapine regulatory portfolio supports customer registrations globally:
- US FDA Drug Master File (Type II) — active, with Letters of Authorization provided within 3 business days
- EU CEP (Certificate of Suitability) — granted and current
- Korea MFDS registration
- WHO Prequalification Programme compliance
- China NMPA registration
- Complete ICH Q1A stability data with 60-month long-term results
- Nitrosamine risk assessment completed per latest FDA/EMA guidance
- Mutagenic impurity assessment per ICH M7
Our regulatory team maintains all filings current and provides rapid responses to customer and agency technical queries.
Packaging & Logistics
Standard packaging configurations for Mirtazapine API:
- Primary: Double polyethylene bags with tamper-evident ties
- Secondary: Fiber drums (25 kg net) with HDPE liner, or aluminum-lined boxes (1 kg, 5 kg)
- UN-certified packaging available for hazardous goods classification where applicable
- Storage: Below 25°C, protected from light and moisture
- Shelf life: 48 months from date of manufacture
We export through Qingdao and Shanghai ports with transit times of 20-30 days to European ports and 15-20 days to Southeast Asian destinations. FOB, CIF, and DDP Incoterms are available.
Competitive Pricing & Supply Reliability
Our Mirtazapine pricing is among the most competitive globally, underpinned by:
- Large-scale production achieving significant economies of scale
- Optimized synthetic route with high atom economy and minimal waste
- In-house intermediate production eliminating supply chain markups
- Efficient solvent recovery and catalyst recycling programs
We maintain strategic inventory to support rapid fulfillment, with standard lead times of 2-3 weeks for quantities up to 500 kg. Annual supply agreements with guaranteed pricing and allocation are available for qualified customers. Contact our CNS API sales team for competitive quotations and sample arrangements.