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Epirubicin hydrochloride manufacturers

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Country of origin : Mexico

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epirubicin hydrochloride

Injection 10 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Mexico
GMP approvals
COFEPRIS
Manufacturer #18807
It is a company formed exclusively for the manufacture of highly specialized drugs. The company has the vision to become a worldwide leader based on technical and economic growth, based on the value of our products, technologies, and services. It ensures the supply, availability, and affordability of their products.

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EPIRUBICIN HYDROCHLORIDE

Epirubicin is an anthracycline in chemotherapy-related to breast cancer. It is often used with other medications to treat breast cancer, especially in patients who have had surgery to remove the tumor or had ovarian, gastric, lung cancers and lymphomas. Epirubicin Hydrochloride is the hydrochloride salt of the anthracycline antineoplastic antibiotic called doxorubicin. Its role is to intercalate into DNA and inhibit topoisomerase II. This further inhibits DNA replication and ultimately, interferes with RNA and protein synthesis. DNA and RNA synthesis is a result of Intercalating complexes. The mechanisms leading to cell death by triggering DNA cleavage by topoisomerase II. Is postulated, that the underlying mechanism could be binding to cell membranes and plasma proteins delivering the compound's cytotoxic effects. Epirubicin also generates cell and DNA damage-causing free radicals. Epirubicin Hydrochloride is sold under the brand names Ellence, Pharmorubicin and Epirubicin Ebewe amongst others. Upjohn file for FDA approval for their node-positive breast cancer in 1984. However, the research in the area was first published in 1980. Later in 1999, Pharmacia, by now part of Upjohn was granted FDA approval as a component of adjuvant therapy in node-positive patients.

Dosage and administration

Epirubicin Hydrochloride is sold as Injection, intended for intravenous administration in 50 mg or 25 mL, 200 mg or 100 mL clear red solution in a single-dose vial. It should not be injected through the intramuscular or subcutaneous route. The recommended adult dose is 100 to 120 mg/m2 administered as an intravenous bolus. Those getting this medication are advised to take prophylactic antibiotic therapy.

The price of Epirubicin Hydrochloride

In the USA, the consumers have to pay around $50 for a supply of 25 milliliters of Epirubicin intravenous solution containing 2 mg/ml. In India, the cost of the 500ml injection is USD 28USD.

How does Epirubicin Hydrochloride Work?

Epirubicin Hydrochloride actions inhibit DNA and RNA synthesis. It achieves this steric obstruction as it intercalates between DNA base pairs triggering DNA cleavage. This is done by topoisomerase ii. Epirubicin Hydrochloride generates cytotoxic free radicals while inhibiting DNA helicase. It is rapidly and extensively distributed into body tissues.

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