Etrasimod API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Etrasimod API Manufacturer & Supplier in India

Etrasimod is an orally active, selective sphingosine-1-phosphate (S1P) receptor modulator and active pharmaceutical ingredient (API). It is designed to modulate lymphocyte trafficking and is used therapeutically in certain immune-mediated inflammatory diseases.

Etrasimod selectively targets S1P receptor subtypes and reduces the circulation of certain lymphocytes, thereby modulating immune responses.

What is Etrasimod?

Etrasimod is a synthetic small-molecule immunomodulatory agent administered orally. It has activity primarily at S1P receptor subtypes 1, 4 and 5 (S1P₁, S1P₄ and S1P₅).

CAS Number: 1206123-37-6
Molecular Formula: C₂₆H₂₆F₃N₅O₃
Molecular Weight: 513.52 g/mol

Mechanism of Action

Etrasimod acts as a selective modulator of S1P receptors, particularly S1P₁, S1P₄ and S1P₅.

Its immunological effects include:

  • Modulation of S1P receptor signaling
  • Reduction of circulating lymphocytes
  • Alteration of lymphocyte trafficking
  • Reduction of lymphocyte migration into inflamed tissues
  • Modulation of immune-mediated inflammatory responses

Pharmaceutical Applications

Etrasimod is used in approved pharmaceutical formulations for:

  • Ulcerative colitis
  • Treatment of adults with moderately to severely active ulcerative colitis who meet applicable treatment criteria

The exact therapeutic application depends on the approved formulation, country and applicable regulatory labeling.

Etrasimod API

Etrasimod is a small-molecule immunomodulatory API with defined chemical and physicochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances, stereochemical purity and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Chiral purity / stereochemical purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Etrasimod should comply with the applicable approved specification and relevant regulatory requirements.

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Store Etrasimod in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
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