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About Capecitabine API

Product
  • Therapeutic Category抗がん/腫瘍

  • API Technology

    High Potent

  • Dose Form

    Oral Solid/Tablets

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Russia DMF, Korea DMF, China DMF

Mechanism of Action

Enzymes convert capecitabine to 5-fluorouracil (5-FU) in vivo. Both normal and tumor cells metabolize 5-FU to 5-fluoro-2’-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms. First, FdUMP and the folate cofactor, N5-10-methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2’-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division. Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.

Indication

XELODA (capecitabine) is a nucleoside metabolic inhibitor with antineoplastic activity indicated for:

  • Adjuvant Colon Cancer
  • Patients with Dukes’ C colon cancer
  • Metastatic Colorectal Cancer
  • First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred
  • Metastatic Breast Cancer
  • In combination with docetaxel after failure of prior anthracycline-containing therapy
  • As monotherapy in patients resistant to both paclitaxel and anthracycline containing regimen

Dr. Reddy’sの専門知識・技術

ハイデラバード(インド)に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬(API)供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API(HPAPI /腫瘍学薬)など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。

RFQ Form

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FAQs

What is CAPECITABINE API used to treat?
  • It is used to treat Breast cancer, gastric cancer and colorectal cancer.

What are the dosage strengths available for CAPECITABINE API?
  • Available in oral tablet form - 150mg & 500 mg

What drug class is CAPECITABINE API?
  • Capecitabine belongs to the group of medicines called antineoplastics (cancer medicines).

What should be monitored while taking CAPECITABINE API?
  • Allergy to 5-fluorouracil or. Kidney disease, severe or. Shortage of an enzyme called dihydropyrimidine dehydrogenase (DPD) that your body needs.

What is the process available for ordering CAPECITABINE API ?
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.