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Gemcitabine Hydrochloride

Gemcitabine Hydrochloride
CAS Number: 122111-03-9

Gemcitabine Hydrochloride

Therapeutic Category
Anti-Cancer/ Oncology
API Technology
High Potent
Dose From
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
USA
Canada
CEP
China
Japan
Korea
Singapore
Taiwan
Russia
Brazil
Innovator Brand (USA)
Gemzar

Mechanism of Action

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.

Indication

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 Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) suppliers globally. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea and 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 Gemcitabine Hydrochloride 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.

We are here to help, if you have any country specific requirements.

Contact Us

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Email us: api@drreddys.com |   +91 40 49002253

Disclaimer

Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes patent infringement. Availability may be restricted to certain markets or countries. Please Contact Us for more information on availability and product suitability.

All product information, including that with regard to active pharmaceutical ingredients (API), the indication, and possible mechanism(s) of action, is based on publicly available product label.

  Email us: api@drreddys.com |   +91 40 49002253