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About Lenvatinib Mesylate ( MIBK Solvate) API

Product
  • Therapeutic CategoryAnti-Cancer/ Oncology

  • API Technology

    Prostaglandins

  • Dose Form

    Oral Solid/Capsules

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, Brazil DMF, Canada DMF, Korea DMF

Mechanism of Action

Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET

Indication

envatinib is indicated for the treatment of the following cancerous conditions:5

Differentiated Thyroid Cancer (DTC)

  • Treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer

Renal Cell Carcinoma (RCC)

  • First-line treatment, in combination with pembrolizumab, in adult patients with advanced renal cell carcinoma (RCC)
  • Treatment of advanced renal cell carcinoma, in combination with everolimus, in adult patients who have previously tried ≥1 anti-angiogenic therapy

Hepatocellular Carcinoma (HCC)

  • First-line treatment of patients with unresectable hepatocellular carcinoma

Endometrial Carcinoma

  • Treatment of advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), in combination with pembrolizumab, in patients who have experienced disease progression following prior systemic therapy and are not candidates for curative surgery or radiation

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Lenvatinib Mesylate ( MIBK Solvate) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Lenvatinib Mesylate ( MIBK Solvate) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.