Doramectin 117704-25-3 — China API Manufacturer | BP USP Veterinary Grade R&D to Production

China Manufacturing Landscape for Doramectin

Doramectin (CAS 117704-25-3) is a potent macrocyclic lactone antiparasitic agent belonging to the avermectin family, widely used in veterinary medicine for the treatment and prevention of internal and external parasites in cattle, swine, and other livestock. China has established itself as a dominant global supplier of Doramectin API, with multiple production facilities dedicated to avermectin-class compound production. Our facility uses fermentation-based biosynthesis technology combined with advanced downstream processing to deliver veterinary-grade Doramectin at globally competitive prices.

The Chinese veterinary API manufacturing sector has undergone significant modernization over the past decade, with facilities now rivaling international standards in process control, analytical capability, and environmental compliance. Our Doramectin production line benefits from this industry-wide elevation, incorporating state-of-the-art fermentation technology and purification systems that consistently produce material meeting the most demanding pharmacopeial specifications.

Manufacturing Process & Facility Overview

Doramectin production at our facility employs a semi-synthetic approach beginning with the fermentation of a mutant strain of Streptomyces avermitilis, followed by chemical modification to introduce the cyclohexyl group characteristic of Doramectin. The fermentation process is conducted in stainless steel bioreactors ranging from 5,000L to 50,000L capacity, with precise control of dissolved oxygen, pH, temperature, and nutrient feed rates via automated bioprocess control systems.

Downstream processing involves solvent extraction, chromatographic purification using preparative HPLC systems, crystallization, and controlled drying. The entire production sequence operates within quality-compliant facilities featuring segregated fermentation and chemical synthesis areas, clean-in-place (CIP) systems, and validated environmental monitoring programs. Annual production capacity exceeds 5 metric tons of finished Doramectin API.

Quality Standards & Multi-Pharmacopeial Compliance

Our Doramectin API is manufactured and tested in compliance with British Pharmacopoeia (BP) and United States Pharmacopeia (USP) monograph specifications. Complete quality control testing includes assay by HPLC (purity ≥95.0%), identification by UV spectroscopy and HPLC retention time comparison, related substances profiling with individual impurity limits, residual solvents by GC-HS per ICH Q3C, water content by Karl Fischer method, and microbial limit testing.

Our QC laboratory is equipped with Waters and Agilent HPLC platforms, validated for Doramectin analysis with method specificity, linearity, accuracy, and reliableness confirmed per ICH Q2(R1) guidelines. The facility operates under a complete quality management system with regular internal audits and has successfully passed inspections from multiple international regulatory authorities.

Regulatory Documentation & Export Support

We provide full regulatory documentation packages supporting veterinary drug registration across global markets. Standard documentation includes batch-specific Certificates of Analysis, Certificates of Quality Compliance, Drug Master File (DMF) documentation, MSDS/SDS in GHS format, and stability study reports conducted under ICH conditions. Our regulatory team has extensive experience supporting customer registrations with veterinary drug authorities including the FDA-CVM, EMA-CVMP, and equivalent agencies across Asia-Pacific, Latin America, and Africa.

We maintain active veterinary drug manufacturing licenses issued by the Chinese Ministry of Agriculture and Rural Affairs, and our export documentation is prepared in compliance with international trade requirements for veterinary pharmaceutical products.

Packaging & Global Logistics

Doramectin API is packaged in light-protected, moisture-barrier aluminum foil bags within HDPE drums, with standard packaging units of 5 kg and 25 kg. The product is packed under nitrogen atmosphere to prevent oxidative degradation. All packaging materials are pharmaceutical-grade and fully traceable through our ERP system. Custom packaging configurations are available upon request for specific customer requirements.

International shipments are coordinated through our experienced logistics team with options for FOB, CIF, and DDP Incoterms. Temperature-controlled shipping is available for destinations with extreme climate conditions. Standard ocean freight transit times are 18-25 days to major European ports and 22-30 days to South American destinations. Expedited air freight delivery is available within 5-7 business days worldwide.

Competitive Pricing & Supply Reliability

Our integrated manufacturing model, from fermentation through final API production, eliminates supply chain intermediaries and enables competitive pricing that delivers significant cost advantages to international buyers. We offer flexible pricing structures including spot pricing, quarterly contracts, and annual supply agreements with price-lock guarantees that protect customers from raw material market fluctuations.

Production planning is supported by rolling demand forecasting systems, and we maintain strategic finished goods inventory to support rapid order fulfillment. Our supply reliability record shows greater than 97% on-time delivery performance, backed by a dedicated international sales team providing responsive communication across multiple time zones.

Doramectin Technical Specifications