盐酸吉西 他滨 API
CAS Number: 122111-03-9
About 盐酸吉西 他滨 API
Therapeutic Category
Anti-Cancer/ Oncology
API Technology
High Potent
Dose Form
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, Brazil DMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF
作用机制
Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (self-potentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.适应症
Gemzar® is a nucleoside metabolic inhibitor indicated:
- In combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum- based therapy.
- In combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
- In combination with cisplatin for the treatment of non-small cell lung cancer.
- As a single agent for the treatment of pancreatic cancer.
Dr. Reddy's的专长
Dr. Reddy's总部位于印度海得拉巴，是全球领先的活性药物成分（API）供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。
Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API（如类固醇，多肽，复杂长链分子和高效API（HPAPI /肿瘤药物））方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准，从而为这一专业知识提供补充。 Dr. Reddy's博士 盐酸吉西 他滨 API是研发，知识产权和监管方面广泛专业知识的结果。
帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量，安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化，从而避免短缺并满足需求的突然激增。
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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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免责声明
本網站上的任何信息，包括對任何產品或服務的任何提及，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得提供或供應用於商業用途。但是，在某些情況下，雷迪博士可自行決定並根據當地法律要求，在存在此類監管豁免的任何地方，提供此類產品的研究數量，以根據《印度專利法》第 107A 條（Bolar 豁免）進行監管提交。購買者應對其各自市場的產品或服務（包括專利情況）進行獨立評估，並對所有與專利相關的責任負責。 Dr. Reddy's 不承擔任何明示或暗示的保證，包括但不限於適銷性、適用於特定用途和非侵權的保證。