Marbofloxacin 115550-35-1 — China API Manufacturer | EP USP Veterinary Grade R&D to Production

China Manufacturing Landscape for Marbofloxacin

Marbofloxacin (CAS 115550-35-1) is a third-generation fluoroquinolone antibiotic developed exclusively for veterinary use, with broad-spectrum bactericidal activity against both Gram-positive and Gram-negative pathogens. It is widely used in companion animal medicine for the treatment of skin infections, urinary tract infections, and respiratory infections in dogs and cats, as well as in livestock for various bacterial diseases. China has established itself as a major manufacturing hub for veterinary fluoroquinolone APIs, and our production facility produces Marbofloxacin at commercial scale for veterinary pharmaceutical companies worldwide.

The Chinese veterinary API manufacturing sector has undergone significant modernization, with facilities now incorporating advanced synthesis technology, rigorous quality management systems, and complete environmental controls. Our Marbofloxacin production benefits from deep expertise in fluoroquinolone chemistry accumulated across our broader quinolone product portfolio, enabling efficient production with consistent pharmacopeial quality at competitive pricing.

Manufacturing Process & Facility Overview

Marbofloxacin production at our facility employs a multi-step chemical synthesis involving construction of the fluorinated quinolone core structure, followed by introduction of the cyclopropyl group at N-1, the oxadiazine ring system, and the methylamino piperazine side chain. The synthesis requires careful control of fluorination chemistry, cyclopropanation conditions, and heterocyclic ring formation to ensure high yield and isomeric purity.

The production facility features dedicated fluoroquinolone synthesis suites with corrosion-resistant reactor systems, high-temperature reaction capability for key cyclization steps, advanced chromatographic purification equipment, and controlled crystallization systems for consistent crystal form production. The facility operates under veterinary quality standards with validated HVAC systems, environmental monitoring, and complete waste treatment including specialized handling of fluorine-containing waste streams. Annual production capacity exceeds 30 metric tons of finished Marbofloxacin API.

Quality Standards & Multi-Pharmacopeial Compliance

Our Marbofloxacin API is manufactured and tested in compliance with European Pharmacopoeia (EP) and United States Pharmacopeia (USP) veterinary monograph specifications. The complete quality control program includes assay by validated HPLC method (purity ≥99.0%), identification by IR spectroscopy, UV spectroscopy, and HPLC retention time, related substances profiling including fluoroquinolone synthesis by-products, water content by Karl Fischer titration, residue on ignition, heavy metals determination, and residual solvent analysis per ICH Q3C guidelines.

Crystal form is confirmed by powder X-ray diffraction analysis to ensure consistency with pharmacopeial reference standards. Our QC laboratory maintains validated analytical methods specifically developed for fluoroquinolone characterization, with demonstrated specificity for all pharmacopeially listed impurities. The quality management system is certified to ISO 9001:2015, and the facility holds valid veterinary drug manufacturing licenses from Chinese regulatory authorities.

Regulatory Documentation & Export Support

We provide complete regulatory documentation to support customer veterinary drug registration activities globally. Available documentation includes Drug Master File (DMF) references for veterinary use, batch-specific Certificates of Analysis, Certificates of Quality Compliance, MSDS/SDS in GHS format, stability study data under ICH conditions, and detailed manufacturing process descriptions. Our regulatory team has experience supporting registrations with veterinary drug authorities including FDA-CVM, EMA-CVMP, and national veterinary regulatory bodies across Asia-Pacific, Latin America, the Middle East, and Africa.

We maintain active veterinary API export licenses and provide all necessary export documentation including Certificates of Pharmaceutical Product (CPP) in WHO format, free sale certificates, and market-specific regulatory documents as required by destination country authorities.

Packaging & Global Logistics

Marbofloxacin API is packaged in double-layer polyethylene bags within fiber drums, with standard net weights of 25 kg per drum. Smaller packaging units of 1 kg, 5 kg, and 10 kg are available for development quantities and smaller-scale production. All packaging provides light protection and is sealed under controlled conditions with complete GHS-compliant labeling and lot traceability coding linked to our ERP system.

International shipping is coordinated through established logistics partnerships with options for FOB, CIF, and DDP Incoterms. Marbofloxacin is shipped under ambient temperature conditions with standard packaging protection. Ocean freight transit times average 18-25 days to European destinations and 20-30 days to Latin American ports. Air freight is available for urgent requirements with delivery within 5-7 business days globally.

Competitive Pricing & Supply Reliability

As a large-scale fluoroquinolone manufacturer with integrated raw material and intermediate production capabilities, we offer Marbofloxacin at highly competitive competitive pricing. Our pricing structure includes volume-based tiered discounts, annual contract pricing with stability guarantees, and preferential terms for long-term supply partnerships. The combination of Chinese manufacturing cost advantages and our operational efficiency delivers significant savings compared to alternative sourcing options.

Supply reliability is underpinned by substantial production capacity, efficient inventory management with maintained safety stock, and diversified raw material sourcing to mitigate supply chain risks. Our track record demonstrates consistent on-time delivery performance exceeding 97% across all international veterinary API accounts, supported by dedicated account management and responsive customer service.

Marbofloxacin Technical Specifications