Why is tylosin classified as a macrolide and how does it compare to other macrolides?

Tylosin is a 16-membered macrolide lactone, structurally distinct from 14-membered macrolides like erythromycin. The 16-membered ring confers stability against acid degradation in the stomach and reduces the likelihood of inducing macrolide resistance through erm gene methylation. Tylosin retains excellent activity against Mycoplasma species and Lawsonia intracellularis, where some newer macrolides show reduced potency.

What regulatory restrictions apply to tylosin phosphate as a feed additive?

Regulatory status varies by country. The EU banned tylosin as a growth promoter in 2006 under Regulation (EC) No 1831/2003 but retained it for therapeutic use. The US permits tylosin in feed under VFD (Veterinary Feed Directive) since 2017, requiring veterinary oversight. China, Brazil, India, and most Asian, Latin American, and African markets continue to permit tylosin phosphate for both therapeutic feed medication and growth promotion. Always verify local regulations before importing.

Tylosin Phosphate | CAS 1405-53-4 | Veterinary API Supplier China

Name: Tylosin Phosphate
SKU: 1405-53-4
Availability: InStock

Quick Facts

CAS Number	1405-53-4
Molecular Formula	C₄₆H₈₀NO₂₁P
Molecular Weight	1014.106
Pharmacopoeia	CVP
Packaging	25 KG/DRUM

GMP Certified

Product Overview

Tylosin was discovered in 1961 by researchers at Eli Lilly and Company from a soil sample containing Streptomyces fradiae collected in Thailand — the name "tylosin" derives from ty (Thai) + los (Lilly) + -in (suffix for antibiotics). It is a 16-membered macrolide lactone, structurally distinct from 14-membered macrolides like erythromycin. The 16-membered ring confers superior acid stability in the gastrointestinal tract and lower cross-resistance induction through erm gene methylation compared to 14-membered macrolides.

Tylosin Phosphate is the phosphate salt form specifically designed for feed incorporation. Unlike the water-soluble tartrate salt used for drinking water medication, the phosphate salt has lower water solubility and is formulated as a premix for uniform blending into animal feed. This delivery method is ideal for prophylactic programs, growth promotion, and long-duration administration in large flocks and herds where individual animal dosing is impractical.

Tylosin acts by binding to the 50S ribosomal subunit of susceptible bacteria, inhibiting protein synthesis through blockade of peptide bond formation and translocation. Its spectrum covers Gram-positive bacteria (Staphylococcus, Streptococcus, Clostridium), mycoplasma species (Mycoplasma gallisepticum, M. synoviae, M. hyopneumoniae), and certain Gram-negative organisms including Lawsonia intracellularis, the causative agent of porcine proliferative enteropathy (ileitis). Beyond direct antibacterial activity, tylosin demonstrates immunomodulatory effects, reducing inflammatory cytokine production and neutrophil infiltration in respiratory and enteric infections.

As of mid-2026, global tylosin phosphate demand is driven by expanding poultry and swine production across Southeast Asia, Latin America, and Africa. China dominates global API production, with manufacturing concentrated in Ningxia, Inner Mongolia, and Shandong provinces. Regulatory landscapes vary by market — the EU restricts tylosin to therapeutic use only, while most Asian, African, and Latin American markets permit both therapeutic and growth-promoting applications. KingWish supplies GMP-certified tylosin phosphate meeting CVP standards, supporting feed premix manufacturers and veterinary pharmaceutical companies in over 100 countries.

Quality Specifications

Potency (Assay)	≥ 900 IU/mg, per CVP monograph
pH (1% suspension)	5.0-7.5, per CVP
Loss on Drying	≤ 5.0%
Heavy Metals	≤ 20 ppm; arsenic ≤ 2 ppm
Residual Solvents	Compliant with ICH Q3C
GMP Status	Manufactured under ICH Q7 GMP conditions

Veterinary Applications

Soluble Powder (Poultry)

Feed additive for control of chronic respiratory disease (CRD) in broilers and layers. Reduces Mycoplasma gallisepticum transmission and severity.

Swine Feed Additive

Growth promotion and prevention of swine dysentery and mycoplasmal pneumonia. Mixed into complete feed at therapeutic or subtherapeutic levels.

Therapeutic Areas

Poultry: Chronic respiratory disease (CRD), mycoplasma infections
Swine: Swine dysentery, mycoplasmal pneumonia, growth promotion
Livestock: Mycoplasma infections, feed additive for growth promotion

Sourcing Tylosin Phosphate: Key Checks

Documentation

Request batch-specific CoA with potency assay (IU/mg), loss on drying, and pH data. For feed-grade product, verify compliance with CVP standards. GMP certificate confirming ICH Q7 manufacturing conditions is essential for regulated markets. DrugBank reference

Red Flags

Low potency assay (below 850 IU/mg), inconsistent color or odor between batches, reluctance to share CoA before purchase order, missing residual solvent statement, and suppliers who cannot differentiate between phosphate and tartrate salt specifications.

Packaging & Logistics

Standard packaging: 25 KG/DRUM with PE liner. Store at room temperature, protected from light and moisture. Shelf life typically 24-36 months when properly stored. Custom packaging available for premix manufacturers requiring specific drum sizes.

Market Context

Global tylosin market projected to grow through 2035 driven by expanding poultry production in Southeast Asia and Africa. China accounts for >60% of global API supply. Regulatory divergence between EU (therapeutic only) and developing markets (dual-use) creates distinct sourcing tiers — verify that your supplier's product profile matches your target market's regulatory requirements.

Frequently Asked Questions

Tylosin phosphate is designed for feed incorporation — it is less water-soluble and formulated as a premix for oral administration via medicated feed. Tylosin tartrate is the water-soluble salt used for drinking water medication and injectable formulations. Phosphate is the preferred form for growth promotion and prophylactic feed programs where consistent daily intake via feed is the goal. Tartrate is used for therapeutic treatment of active infections requiring rapid onset via drinking water.

In broilers and layers, tylosin phosphate is mixed into complete feed at 50-110 g/ton for chronic respiratory disease (CRD) prevention and 22-55 g/ton for growth promotion. It reduces Mycoplasma gallisepticum colonization, improves feed conversion ratio, and decreases mortality associated with respiratory disease. Treatment is typically administered for 5-7 consecutive days in feed. Withdrawal period before slaughter is generally 5 days for broilers.

Tylosin is a 16-membered macrolide lactone, structurally distinct from 14-membered macrolides like erythromycin. The larger ring confers several advantages: (1) superior acid stability in the stomach, reducing degradation during oral administration; (2) reduced likelihood of inducing macrolide-lincosamide-streptogramin B (MLSB) resistance through erm gene methylation; (3) excellent activity against Mycoplasma species and Lawsonia intracellularis, where some 14-membered macrolides show reduced potency. Tylosin also has documented immunomodulatory and anti-inflammatory effects beyond direct antibacterial activity.

Regulatory status varies significantly by country. The EU banned tylosin as a growth promoter in 2006 under Regulation (EC) No 1831/2003 but retained it for therapeutic use via medicated feed. The US regulates tylosin in feed under the Veterinary Feed Directive (VFD) since 2017, requiring veterinary oversight. China, Brazil, India, and most Asian, Latin American, and African markets continue to permit tylosin phosphate for both therapeutic feed medication and growth promotion. Always verify your target market's current regulations before importing — KingWish can assist with the necessary documentation for each jurisdiction.

Standards: CVP | CAS: 1405-53-4 | Quality data verified against pharmacopoeia monograph COA and MSDS available | DrugBank | July 2026