Tulathromycin 217500-96-4 — China API Manufacturer | Veterinary API R&D to Production

China Manufacturing Landscape for Tulathromycin

Tulathromycin (CAS 217500-96-4) is a semi-synthetic triamilide macrolide antibiotic developed specifically for veterinary use, primarily for the treatment and prevention of bovine and swine respiratory disease. Marketed as Draxxin, Tulathromycin is characterized by its extended tissue half-life enabling single-dose treatment protocols, making it a preferred choice for livestock producers worldwide. Chinese API manufacturers have developed efficient semi-synthetic production routes for Tulathromycin, establishing China as a competitive supply base for this high-value veterinary antibiotic API.

Our production facility combines China’s well-established macrolide chemistry expertise with dedicated veterinary API manufacturing capabilities to produce pharmaceutical-grade Tulathromycin for export to veterinary pharmaceutical formulators globally. The domestic availability of macrolide fermentation infrastructure for producing erythromycin-derived starting materials provides a substantial cost and supply chain advantage for Chinese Tulathromycin manufacturers.

Manufacturing Process & Facility

Tulathromycin synthesis starts from a macrolide precursor obtained through fermentation of erythromycin-producing Saccharopolyspora erythraea strains, followed by a series of semi-synthetic chemical transformations including reductive amination to introduce the three amine functionalities that define the triamilide structural class. The synthesis involves selective N-alkylation, Beckmann rearrangement or related ring expansion chemistry, and careful protection/deprotection strategies to achieve regioselective modification of the macrolide ring system.

The manufacturing facility integrates both fermentation capacity for starting material production and chemical synthesis suites for semi-synthetic modification, providing full vertical integration. Equipment includes stainless steel fermenters up to 50,000 L, glass-lined chemical reactors from 200 L to 5,000 L, preparative chromatography systems, and controlled crystallization equipment. The facility operates under NMPA veterinary certification with current annual Tulathromycin production capacity of 1,000 kg, supported by quality control laboratories equipped with HPLC-MS/MS, preparative HPLC, and comprehensive microbiology testing capabilities.

Quality Standards & Multi-Pharmacopeial Compliance

Tulathromycin API is produced to veterinary pharmacopeial quality standards aligned with the specifications established for the innovator product. HPLC purity exceeds 95.0% for the combined A-isomer content (regioisomers Tulathromycin A1 and A2), with the ratio of A-isomers to B-isomer maintained within the specified range that defines the commercially acceptable composition. Related substance levels are controlled below specified limits through optimized synthesis and purification conditions.

Quality testing protocols include HPLC assay and isomer ratio analysis, related substances profiling by gradient HPLC, residual solvent analysis by headspace GC, water content by Karl Fischer, elemental impurities by ICP-MS, microbial limits testing, and specific optical rotation. Identity confirmation is performed by IR spectroscopy and mass spectrometry. Stability studies under ICH-aligned conditions demonstrate a 24-month retest period when stored under recommended conditions.

Regulatory Documentation

Comprehensive regulatory documentation is provided to support veterinary pharmaceutical registration applications globally. Documentation packages include Veterinary Drug Master Files in CTD-V format, detailed manufacturing process descriptions with flow diagrams and critical process parameter identification, analytical method validation reports per VICH guidelines, five-batch analysis data, forced degradation study results, and stability data under long-term and accelerated conditions. quality certificates, quality system documentation, environmental monitoring data, and starting material qualification packages are included. Our regulatory team provides direct support to customers during the registration process, including preparation of responses to regulatory authority questions.

Packaging & Logistics

Tulathromycin API is packaged in pharmaceutical-grade HDPE containers or double PE bag-lined fiber drums, available in 500 g, 1 kg, 5 kg, and 25 kg units. Light-protective secondary packaging is employed as standard. Shipments are arranged via temperature-controlled air freight for international delivery within 5-12 business days. For bulk orders exceeding 100 kg, sea freight options are available with transit times of 20-35 days to major international ports. Full export documentation including CoA, MSDS, veterinary health certificates, and customs classification support is provided with every shipment.

Competitive Pricing & Supply Reliability

Competitive pricing for Tulathromycin is structured to be competitive with alternative global sources while reflecting our commitment to consistent quality and regulatory compliance. Volume-based pricing tiers are available from development quantities through multi-hundred kilogram annual supply commitments. Standard production lead times are 6-8 weeks for confirmed orders, with expedited scheduling available for established customers with urgent requirements. Our integrated fermentation and chemical synthesis operations provide production planning flexibility, and we maintain intermediate inventory sufficient to support rapid response to unexpected demand increases.

Tulathromycin Specifications