Entrectinib API Manufacturer & Supplier in India

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

Entrectinib API

Entrectinib is a synthetic, orally active tyrosine kinase inhibitor (TKI) developed for targeted cancer treatment. It inhibits the tropomyosin receptor kinase (TRK) A, B and C proteins, as well as ROS1 and ALK kinases. It is used in precision oncology for tumors driven by specific molecular alterations.

Entrectinib is particularly associated with treatment of NTRK gene fusion-positive solid tumors and ROS1-positive non-small cell lung cancer (NSCLC). Its ability to target TRK and ROS1 signaling makes it an important pharmaceutical ingredient in targeted oncology.

What is Entrectinib?

Entrectinib is a small-molecule kinase inhibitor that blocks signaling from TRKA, TRKB, TRKC, ROS1 and ALK. These kinases can contribute to abnormal cellular proliferation and tumor survival when activated by gene fusions or other molecular alterations.

Entrectinib has the molecular formula C₃₁H₃₄F₂N₆O₂ and a molecular weight of approximately 560.65 g/mol.

Entrectinib API Manufacturer & Supplier

Swapnroop Drugs and Pharmaceuticals provides Entrectinib API for qualified pharmaceutical manufacturing, formulation development, oncology research and pharmaceutical sourcing requirements.

Entrectinib is a specialized targeted oncology API relevant to NTRK fusion-positive and ROS1-positive cancer drug development.

Mechanism of Action

Entrectinib inhibits the kinase activity of TRKA, TRKB and TRKC, encoded by the NTRK1, NTRK2 and NTRK3 genes. It also inhibits ROS1 and ALK.

Blocking these signaling pathways can inhibit downstream signaling involved in tumor-cell proliferation, survival and migration.

Pharmaceutical Applications

Entrectinib is associated with:

  • NTRK fusion-positive solid tumors
  • ROS1-positive NSCLC
  • Targeted oncology
  • TRK inhibitor drug development
  • ROS1 inhibitor research
  • Precision cancer medicine
  • Oncology pharmaceutical formulation development

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 150°C – 154°C
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