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Epirubicin hydrochloride manufacturers

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Country of origin : India

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16 products found

epirubicin hydrochloride

Injection 10 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #19783
This pharmaceutical company specializes in the development and production of a wide range of generic and branded medications. Their manufacturing facility, located in an excise-free zone, is WHO-GMP certified and adheres to MHRA UK and TGA standards. They offer various dosage forms, including tablets, capsules, oral liquids, dry syrups, parenterals, MDIs, powders, and ointments. The company focuses on several key therapy areas such as antibiotics, anti-inflammatories, cardiovascular medications, anti-diabetic drugs, oncology products, and vitamins. They export their products to regions including Central Asia and the Caucasus.

Manufacturer usually replies in 2 days

epirubicin hydrochloride

Vials, lyophilized injection 10 mg, 50 mg, 100 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #30013
The company, established in 2016 and later restructured as a private limited entity in 2018, specializes in manufacturing APIs, advanced intermediates, and finished dosage forms. With robust relationships in the pharmaceutical industry, it has built a strong customer base of over 50 clients and achieved an annual turnover exceeding 200 crore. The company operates extensive facilities capable of scaling from lab-scale development to bulk production, supporting its global expansion strategy. Committed to ethical practices and social responsibility, the company aims to make healthcare affordable and accessible worldwide, with export markets across Asia, Latin America, and Africa.

Manufacturer usually replies in 2 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 6 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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