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15 products found

epirubicin hydrochloride

Injection 10 mg, 50 mg, 100 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, WHO
Manufacturer #1356
The company, established in 2005, focuses on generic pharmaceuticals, particularly in niche segments like oncology, CNS, gastroenterology, and anti-diabetics. Specializing in the development of finished formulations and product dossiers, the company prepares for upcoming patent expirations to expand its market presence. With state-of-the-art, WHO-GMP certified manufacturing facilities across the country, the company supplies high-quality formulations globally under its own license and through contract manufacturing. Committed to improving quality of life, the company emphasizes innovation and consistency in its product offerings, aiming to meet the specific needs of diverse markets worldwide.

Manufacturer usually replies in 10 days

epirubicin hydrochloride

Injection 10 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #21110

This CTD dossier owner and manufacturer focuses on providing high-quality oncology drugs to over 20 countries worldwide. With more than two decades of experience, they specialize in manufacturing sterile oncology dosage forms, including liquid vials, lyophilized formulations, and complex NDDS-based products. Their product portfolio includes over 35 products targeting various solid tumors and hematological malignancies, with a commitment to palliative care formulations as well. They prioritize research and development, particularly in advanced lyophilized, liposomal, and nanoparticle-based drug delivery systems. Their manufacturing facilities adhere to strict GMP certifications, ensuring product quality and safety. Key therapy areas include oncology, with a focus on solid tumors and hematological malignancies. Principal dosage forms include liquid vials, lyophilized formulations, and complex NDDS (New Drug Delivery Systems) based products. The company emphasizes partnerships with academia, healthcare institutions, and the local community to drive research and development efforts.

Manufacturer usually replies in 8 days

epirubicin hydrochloride

Injection 10 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20801

This CTD dossier owner and manufacturer specializes in producing a wide range of medications across various dosage forms, including tablets, capsules, injections, and syrups. Their focus is on delivering high-quality formulations for human health, evident in their commitment to using state-of-the-art technology and machinery. The company exports its products to several key regions globally, such as Africa, the CIS countries, Central and Latin America, Southeast Asia, and the Pacific. While they haven't specified particular therapy areas, their mission statement emphasizes a dedication to becoming a dominant player in both domestic and international markets. They prioritize maintaining the highest quality standards through rigorous quality control measures and emphasize safe, stable packaging for all products.

Manufacturer usually replies in 13 days

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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.

Finding Epirubicin Hydrochloride Manufacturers and Suppliers

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