China Manufacturing Landscape for Moxidectin (CAS 113507-06-5)
Moxidectin, the second-generation macrocyclic lactone antiparasitic, has gained significant global traction in both veterinary medicine and, more recently, human health applications for onchocerciasis treatment. Our GMP-certified facility in Hebei Province is a leading Chinese manufacturer of Moxidectin API, combining advanced fermentation and semi-synthetic chemistry capabilities to produce this complex molecule at commercial scale. We supply veterinary and human pharmaceutical formulators directly from our factory.
China’s expertise in macrocyclic lactone manufacturing — built upon decades of avermectin and milbemycin production — provides the ideal foundation for Moxidectin synthesis. Our facility leverages this accumulated technical knowledge, specialized equipment, and trained workforce to deliver consistent, high-quality Moxidectin API at globally competitive prices.
Manufacturing Process & Facility
Moxidectin is produced through a semi-synthetic process starting from nemadectin, a natural product obtained by fermentation of Streptomyces cyaneogriseus. The fermentation-derived nemadectin undergoes selective chemical modification including oximation and methoxime formation to yield Moxidectin. Our process development team has optimized both the fermentation stage (achieving high nemadectin titers) and the semi-synthetic conversion (with yields exceeding 80%).
Facility highlights:
- Fermentation facility with bioreactors up to 30,000L for nemadectin production
- Dedicated semi-synthesis suites for chemical modification steps
- Multi-column chromatography systems for high-resolution purification
- ISO Class 7 cleanroom environments for final processing and packaging
- Annual production capacity: 5 metric tons of Moxidectin API
- In-house nemadectin intermediate production ensuring supply chain control
All critical process parameters are monitored through automated systems with deviation alerts, and comprehensive in-process controls ensure consistent product quality at every manufacturing stage.
Quality Standards & Multi-Pharmacopeial Compliance
Our Moxidectin API meets or exceeds USP and EP specifications, with additional quality attributes for human pharmaceutical applications:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to yellowish-white powder | Visual |
| Identification | Positive by IR, HPLC, MS | IR/HPLC/MS |
| Assay (anhydrous basis) | ≥96.0% | HPLC |
| Related Substances (total) | ≤2.0% | HPLC |
| Any Single Impurity | ≤0.5% | HPLC |
| Nemadectin (starting material) | ≤0.5% | HPLC |
| Water Content | ≤1.0% | Karl Fischer |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Heavy Metals | ≤10 ppm | ICP-MS |
| Microbial Limits | TAMC ≤1000 CFU/g, TYMC ≤100 CFU/g | USP <61>/<62> |
Regulatory Documentation
Our Moxidectin regulatory support package covers both veterinary and human pharmaceutical applications:
- US FDA Drug Master File (Type II) — active for both CVM and CDER reference
- EU ASMF available for veterinary and human medicinal product applications
- China NMPA GMP certificate
- Process validation reports for three consecutive commercial-scale batches
- ICH/VICH stability data with 36-month long-term results
- TSE/BSE compliance statement
- Complete impurity characterization and qualification package
- WHO prequalification supporting documentation (for human onchocerciasis application)
Our regulatory team actively monitors evolving requirements for Moxidectin in both veterinary and human health sectors, maintaining our dossiers current with all applicable guidelines.
Packaging & Logistics
Moxidectin packaging is designed for stability and compliance with international shipping standards:
- Primary: Double polyethylene bags, heat-sealed, with desiccant
- Secondary: Fiber drums (5 kg, 10 kg, 25 kg) or HDPE containers (500g, 1 kg)
- Light-protective outer packaging for photosensitive compound
- Storage: Below 25°C, protected from light and moisture
- Shelf life: 36 months from date of manufacture
Global shipping through established logistics partners with FOB, CIF, and DDP Incoterms. Lead time is typically 15-20 business days from order confirmation for standard quantities.
Competitive Pricing & Supply Reliability
Our vertically integrated production — from fermentation through final API — provides significant cost advantages:
- In-house nemadectin production eliminating intermediate procurement costs
- Proprietary high-yield fermentation strains
- Optimized semi-synthetic process with efficient solvent recovery
- Flexible production scheduling accommodating both veterinary bulk orders and smaller human pharma quantities
We support the full range of commercial needs from 50g evaluation samples to multi-ton annual contracts. Special pricing consideration is available for organizations involved in neglected tropical disease programs. Contact our antiparasitic API division for current pricing and technical documentation.