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Country of origin : Switzerland

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epirubicin

Solution for injection 10 mg/5 ml, 50 mg/25 ml, 20 mg/10 ml, 100 mg/50 ml, 200 mg/100 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Switzerland
GMP approvals
EU GMP
Unavailable markets
Germany , Macao , United Kingdom , Vietnam
Available for
Distribution only
Comments
Ref. Pharmorubicin
Manufacturer #269
A pharmaceutical manufacturer based in the EU that is active in 100+ countries selling its products in Europe, North America, Africa, the Middle East, and Asia for 40+ years. Main therapeutic areas include CNS, cardiovascular medication, and anti-infectives. The company's production lines are EU GMP-compliant. Key production lines are Rx and OTC. The company owns 20+ branches in Europe, Africa, and Asia.

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Epirubicin

Epirubicin used for chemotherapy is an anthracycline drug. It can be used to treat breast cancer, who already had surgery to remove the tumor. Epirubicin primarily treats breast and ovarian cancer, gastric cancer, lung cancer, and lymphomas. Like all anthracyclines, Epirubicin intercalates DNA strands resulting in complex formation. This complex inhibits DNA and RNA synthesis. Epirubicin kicks off DNA cleavage by topoisomerase II, which results in a mechanism leading to cell death. It is thought that it works by binding to the cell membranes and plasma proteins in the compound's cytotoxic effects. But it generates free radicals that cause DNA and cell damage. In some chemotherapies, it is favored over Doxorubicin, the most popular anthracycline because it has fewer side effects. Epirubicins different spatial orientation caused by hydroxyl group with opposite chirality accounts for its faster elimination and lower toxicity. Pfizer sells Epirubicin under the brand name Ellence, Pharmorubicin, or Epirubicin Ebewe in the USA and around the world. Upjohn applied for FDA approval for its node-positive breast cancer in 1984 but was turned down due to of lack of data. However, the first trials of Epirubicin in humans started and was published in the early 80s. In 1999 Pharmacia who by then merged with Upjohn, received FDA approval for the use as a component of adjuvant therapy in node-positive patients, however, this Patent protection expired in 2007.

Dosage and administration

Epirubicin is sold as a solution for injection. It is given through the intravenous injection route by placing the needle directly into the tube of a flowing IV solution, that goes into a vein or central line. Epirubicin is a vesicant and can cause extensive tissue damage and blistering if it escapes from the vein. Therefore it is critical that, it is administered by a nurse trained to gives this drug. Any signs of inflammation around the injected area call for immediate medical intervention.

The cost of Epirubicin

In the USA, the cost for an intravenous solution containing 2 mg is around $50 for a supply of 5 milliliters. Whereas in India, a supply of 10 Mg costs only USD 7.5.

How does Epirubicin Work?

Epirubicin, an antitumor antibiotic is made from natural products of species of the soil fungus Streptomyces. They are involved in actions during the multiple phases of the cell cycle and are considered cell-cycle specific. Chemotherapy that works well when cells are dividing is called cell-cycle specific therapies. The scheduling of injection is subject to the type of cells, the rate at which it divides, and the time when it is likely to have the most impact.

Finding Epirubicin Manufacturers and Suppliers:

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