Epirubicin Hydrochloride for Injection 10mg

Epirubicin Hydrochloride for Injection 10mg Technical Specification:

Epirubicin Hydrochloride for Injection 10mg Manufacturers, Suppliers in India:

Taj Pharmaceuticals is the prominent Epirubicin Hydrochloride for Injection 10mg Manufacturers in India bring the best-quality products. Our company Taj Pharma has rich experience in the manufacturing of Epirubicin Hydrochloride for Injection 10mg.

Epirubicin is used in combination with other medications to treat breast cancer in patients who have had surgery to remove the tumor. Epirubicin is in a class of medications called anthracyclines. It works by slowing or stopping the growth of cancer cells in your body.

Taj Pharmaceuticals is a reputed manufacturer and Epirubicin Hydrochloride for Injection 10mg Suppliers in India prefer Taj Pharma is best known for the top standards and consistent quality of its products.

Taj Pharma is well-known Epirubicin Hydrochloride for Injection 10mg Manufacturer in India gives the assurance of high- quality and high standard. The strict quality control ensures that every batch of medicine brings a harmonious standard.

Epirubicin Hydrochloride for Injection 10mg manufactured at Taj Pharma follows IHS/USP/BP (In-House Specifications / United States Pharmacopeia / British Pharmacopeia); i.e. the product is manufactured to comply IHS quality standards which is considered Best in the world. Further, Taj Pharma uses Epirubicin Hydrochloride for Injection 10mg IHS grade best active ingredient to manufacture its Injections to comply with international standards of European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

• Epirubicin Hydrochloride for Injection 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

• Epirubicin Hydrochloride for Injection 10mg
  Each vial contains:
  Epirubicin hydrochloride…………10mg
  Methylparaben……………………….2mg
  Lactose………………..………………. q.s.

THERAPEUTIC INDICATION:

Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.

DIRECTION OF USE:

For Intravenous infusion only. 

Reconstitution for 10mg: Reconstituted with 5ml Sterile Water for Injection resulting in a final concentration of 2mg/ml. Shake vigorously. It may take up to 4 minutes to completely dissolve. Discard unused portion.

See package insert for details.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.

Cytotoxic special handling procedures see insert.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.

Dosage: As directed by an Oncologist.

As Epirubicin Hydrochloride for Injection 10mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Epirubicin Injection 10mg product in Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Epirubicin Hydrochloride for Injection 10mg Regulatory Documents:

Certificate of Analysis (COA)
Method of Analysis (MOA)
Stability Data (Accelerated stability / Long-term stability / Zone 4b)
CTD Dossier / ACTD Dossiers / eCTD Dossiers
Certificate of Pharmaceuticals Product (COPP)
Free Sale Certificate (FSC)