Active Pharmaceutical Ingredient

Tylosin Tartrate API Manufacturer & Supplier in India

Also known as: Tylan; Tylosin tartrate salt

CAS: 1405-54-5Macrolide Antibiotic APIIP / BP / EP / USPGMP CertifiedAurangabad, Maharashtra, India
Tylosin Tartrate API — Mediocon Inc
Tylosin Tartrate — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 1405-54-5  |  MF: C₄₆H₇₇NO₁₇·C₄H₆O₆  |  MW: 1069.21 g/mol

Tylosin Tartrate is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Tylosin Tartrate is the tartrate salt of tylosin, a macrolide antibiotic produced by Streptomyces fradiae. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit and is primarily used in veterinary medicine for the treatment and prevention of respiratory, enteric, and other bacterial infections in livestock and poultry.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Veterinary bacterial infection treatment
  • Mycoplasma infections in livestock
  • Swine respiratory disease management
  • Poultry and cattle antibiotic therapy

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameTylosin Tartrate
Also Known AsTylan; Tylosin tartrate salt
CAS Number1405-54-5
Molecular FormulaC₄₆H₇₇NO₁₇·C₄H₆O₆
Molecular Weight1069.21 g/mol
CategoryMacrolide Antibiotic (Veterinary)
AppearanceWhite to off-white powder
SolubilityFreely soluble in water; soluble in methanol and ethanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.TPF/24033034
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Tylosin Tartrate (CAS 1405-54-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Tylosin Tartrate is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Tylosin Tartrate API

What is the minimum order quantity for Tylosin Tartrate API?
Mediocon Inc supplies Tylosin Tartrate with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Tylosin Tartrate does Mediocon supply?
We supply Tylosin Tartrate conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Tylosin Tartrate API?
Every shipment of Tylosin Tartrate comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Tylosin Tartrate bulk orders?
Standard lead time for Tylosin Tartrate is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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