Teicoplanin API Manufacturer in India

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Teicoplanin API Manufacturer in India

Teicoplanin is a glycopeptide antibiotic produced by fermentation of Actinoplanes teichomyceticus. It consists of several closely related glycopeptide components, including major teicoplanin A2 components and A3 components. Its antibacterial activity results from inhibition of bacterial cell-wall synthesis.

Teicoplanin is primarily used for the treatment of serious infections caused by susceptible Gram-positive bacteria. It is administered parenterally because it has very limited gastrointestinal absorption.

Teicoplanin API Overview

Teicoplanin is identified by CAS No. 61036-62-2. Unlike conventional APIs with one fixed molecular formula, teicoplanin is a complex mixture of related glycopeptides. PubChem describes five major teicoplanin A2 components and four minor components, all sharing a common glycopeptide core but differing in their side chains.

The Japanese Pharmacopoeia defines teicoplanin as a mixture of glycopeptide substances having antibacterial activity produced by Actinoplanes teichomyceticus. Its potency is expressed as mass of teicoplanin per milligram on an anhydrous, de-sodium-chloride and de-residual-solvents basis.

PubChem reports a representative teicoplanin component at 1879.7 g/mol but specifically notes that commercial teicoplanin is a mixture.

Pharmaceutical Applications

Teicoplanin is used as a glycopeptide antibacterial for serious infections caused by susceptible Gram-positive organisms. It inhibits bacterial cell-wall synthesis by interfering with peptidoglycan formation.

Pharmaceutical applications include formulations for infections such as:

  • Serious Gram-positive bacterial infections
  • Complicated skin and soft-tissue infections
  • Bone and joint infections
  • Septicaemia
  • Endocarditis
  • Certain hospital-acquired infections

The exact approved indications vary by country and product authorization.

Quality and Analytical Testing

Teicoplanin requires specialized quality control because it is a complex fermentation-derived antibiotic mixture.

The Japanese Pharmacopoeia includes controls for:

  • Identification
  • pH
  • A2-group content
  • A3-group content
  • Other component content
  • Sodium chloride
  • Heavy metals
  • Arsenic
  • Residual solvents
  • Water
  • Bacterial endotoxins
  • Potency/activity

The JP monograph specifies a minimum potency of 900 μg/mg, calculated on an anhydrous, de-sodium-chloride and de-residual-solvents basis.

Teicoplanin API Manufacturer in India

Swapnroop supports pharmaceutical API requirements with quality-focused analytical testing, technical documentation and supply support for pharmaceutical development and manufacturing.

Teicoplanin API can be supported with appropriate specifications, potency testing and batch-specific quality documentation according to the intended pharmaceutical application.

Packaging and Storage

Teicoplanin should be protected from moisture and inappropriate environmental conditions. Packaging should provide suitable protection against contamination and degradation.

Storage conditions should follow the applicable approved API specification and stability data for the supplied batch.

Documentation

Documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Safety Data Sheet (SDS/MSDS)
  • Potency/assay report
  • HPLC composition profile
  • Residual-solvent report
  • Water-content report
  • Endotoxin report
  • Microbial testing, where applicable
  • Stability information
  • Regulatory documentation, where applicable

Why Choose Teicoplanin API from Swapnroop?

Swapnroop focuses on quality-oriented pharmaceutical API solutions supported by analytical testing and technical documentation. Teicoplanin can be supplied according to agreed specifications and customer requirements for pharmaceutical development and manufacturing.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Heavy Metals 50 ppm
pH (1% Solution) 6.3–7.7
Total Impurities NMT 0.2%
Water Content NMT 15.0%
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