Description

Mitomycin Injection (Mitomycin C)

Healthy Inc is a specialized global supplier and exporter of high-potency cytotoxic antibiotics. We provide high-purity Mitomycin Injection (2 mg / 10 mg / 40 mg), manufactured in WHO–GMP certified oncology containment facilities. This “Multifunctional Alkylator” is a top export to oncology centers, urology clinics, ophthalmology units, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical agent for bladder cancer instillation, GI cancers, and specialized eye surgeries.

Product Overview

This formulation contains Mitomycin (also known as Mitomycin C), an antineoplastic antibiotic isolated from the broth of Streptomyces caespitosus.

The “Bioreductive” Specialist:

• Mechanism (The DNA Cross-Linker): Mitomycin is a “bioreductive alkylating agent.” It is activated by enzymes inside the cell to form reactive intermediates that cross-link DNA strands (specifically at the N-6 position of adenine and O-6/N-7 of guanine). This “zipping” of DNA prevents replication and transcription, causing cell death.
• Intravesical Standard: It is widely used as a “bladder wash” (intravesical instillation) immediately after TURBT surgery to prevent the recurrence of superficial bladder cancer.
• Ophthalmic Utility: Surgeons use it topically during Pterygium and Glaucoma filtration surgery to prevent scarring (fibrosis) by inhibiting fibroblast proliferation.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder (Purple/Blue Cake) in amber glass vials.

*Pack Sizes: Single Vial. (Must be handled with cytotoxic precautions).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Distributors.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Cytotoxic Containment: Manufactured in a dedicated isolator line to prevent cross-contamination and protect operators. Mitomycin is a potent vesicant and carcinogen; our packaging ensures zero external residue on vials.
• Lyophilization Cycle: Mitomycin is heat-sensitive. Our specialized freeze-drying cycle ensures a porous cake that reconstitutes instantly without foam, which is critical for accurate dosing in eye surgeries.

Therapeutic Indications (Human Use)

Indicated for the palliative treatment of disseminated adenocarcinoma:

• Systemic (IV): Stomach (Gastric) Cancer and Pancreatic Cancer (often in combination with 5-FU and Doxorubicin).
• Intravesical (Bladder): Prevention of recurrence of superficial bladder tumors after transurethral resection.
• Ophthalmic (Topical – Off Label): Adjunct in ab externo glaucoma surgery and pterygium excision to prevent haze/recurrence.
• Anal Cancer: In combination with 5-FU and radiation.

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist/Surgeon):

• Route: Intravenous (IV) or Intravesical ONLY.
• Systemic Dose: 20 mg/m² IV as a single dose every 6-8 weeks.
• Bladder Instillation: 20 mg to 40 mg diluted in 20-40 ml water/saline, retained in the bladder for 1-2 hours.
• Administration (IV): MUST be given via a running IV line to avoid extravasation.

Safety Warnings (CRITICAL):

• Extravasation Hazard: EXTREME VESICANT. Leakage into surrounding tissue causes severe necrosis (tissue death), ulceration, and sloughing. If extravasation occurs, stop immediately.
• Bone Marrow Suppression: Cumulative myelosuppression (Thrombocytopenia/Leukopenia) is the dose-limiting toxicity. Monitor blood counts for weeks after therapy.
• Hemolytic Uremic Syndrome (HUS): A serious complication involving kidney failure and hemolytic anemia.
• Pulmonary Toxicity: Can cause interstitial pneumonitis.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Oncology Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.