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Tech Sheet: Gemcitabine API

Gemcitabine Hydrochloride is an analog of the antimetabolite nucleoside deoxycytidine with antineoplastic activity. Gemcitabine is converted intracellularly to the active metabolites difluorodeoxycytidine di-and triphosphate (dFdCDP and dFdCTP)

  • dFdCDP - Inhibits ribonucleotide reductase, decreasing the deoxynucleotide pool available for DNA synthesis.
  • dFdCTP - Incorporates into the DNA, resulting in DNA strand termination and apoptosis.

The timelines of USFDA approval of Gemcitabine Hydrochloride across indications are as follows:

  1. U.S. Food and Drug Administration (USFDA) approved Gemcitabine Hydrochloride to treat non-small cell lung cancer in 1998 and for treating metastatic cancer in 2004.
  2. The U.S. Food and Drug Administration (USFDA) has approved Gemzar® (Gemcitabine Hydrochloride), in combination with Taxol® (paclitaxel), providing a new option in first-line therapy for women battling metastatic breast cancer in 2004. In addition to the United States, Gemzar has been approved for metastatic breast cancer in 32 countries today.
  3. Gemzar is approved in more than 90 countries and is the worldwide standard of care for pancreatic cancer and non-small cell lung, bladder, and breast cancers in many parts of the world.

To know more about our API offerings , please read the technical sheet on Gemcitabine HCL by filling the contact from below.

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本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。

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