Description

Gemcitabine Hydrochloride Injection

Healthy Inc is a specialized global supplier and exporter of high-potency antimetabolite chemotherapies. We provide high-purity Gemcitabine Hydrochloride Injection (200 mg / 1 g / 1.4 g), sourced from WHO–GMP certified sterile cytotoxic facilities. This “First-Line Standard” is a top export to oncology institutes, hepatobiliary centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the absolute gold standard for Pancreatic Cancer and a cornerstone therapy for Non-Small Cell Lung Cancer (NSCLC).

Product Overview

This formulation contains Gemcitabine Hydrochloride, a nucleoside metabolic inhibitor that exhibits antitumor activity.

The “Masked Terminator” Specialist:

• Mechanism (The “Trojan Horse”): Gemcitabine mimics the structure of the nucleoside deoxycytidine. Once inside the cell, it is converted into active metabolites (dFdCDP and dFdCTP) that are incorporated into DNA. It allows one more nucleotide to be added after it (“Masked Chain Termination”), which tricks the DNA repair enzymes into thinking everything is fine until it is too late to fix the break. This triggers apoptosis (cell suicide).
• Pancreatic Cancer Standard: It is the primary drug approved for locally advanced or metastatic adenocarcinoma of the pancreas, offering survival benefits and pain relief where other drugs fail.
• Synergy with Platinum: It is highly synergistic with Cisplatin or Carboplatin, making the “Gem-Plat” doublet a standard regimen for Lung and Bladder cancers.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder for Injection in glass vials.

*Pack Sizes: Tray of 1 Vial. (Cytotoxic Packaging).

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.

• Solubility Engineering: Gemcitabine has incomplete solubility in certain pH ranges. Our formulation uses precise buffering (Sodium Acetate) to ensure the powder dissolves completely in 0.9% Sodium Chloride without precipitation, even at high concentrations (up to 40 mg/ml).
• Crystal Prevention: Unlike many other drugs, Gemcitabine solutions must be kept at room temperature. Our packaging explicitly warns against refrigeration to prevent pharmacy errors that lead to crystal formation and wasted product.

Therapeutic Indications (Human Use)

Indicated for the treatment of advanced or metastatic solid tumors:

• Pancreatic Cancer: First-line treatment for locally advanced or metastatic adenocarcinoma.
• Non-Small Cell Lung Cancer (NSCLC): First-line treatment (in combination with Cisplatin).
• Bladder Cancer: Treatment of advanced or metastatic bladder cancer (with Cisplatin).
• Breast Cancer: Metastatic breast cancer (with Paclitaxel) after failure of anthracycline.
• Ovarian Cancer: Relapsed ovarian cancer (with Carboplatin).

Dosage & Administration

Recommended Dosage (Strictly as per Oncologist):

• Route: Intravenous (IV) Infusion ONLY.
• Pancreatic Cancer: 1000 mg/m² infused over 30 minutes once weekly for up to 7 weeks (then 3 weeks on, 1 week off).
• NSCLC / Bladder: 1000 mg/m² on days 1, 8, and 15 of a 28-day cycle.
• Infusion Time (CRITICAL): Strictly 30 minutes. Prolonging infusion beyond 60 minutes significantly increases toxicity (severe myelosuppression and hypotension).
• Reconstitution: Add 5ml (for 200mg) or 25ml (for 1g) of 0.9% Sodium Chloride. Shake to dissolve.

Safety Warnings (CRITICAL):

• Myelosuppression: Severe leukopenia, thrombocytopenia, and anemia. Dose modification required if Absolute Neutrophil Count (ANC) < 1000.
• Pulmonary Toxicity: Can cause severe pulmonary edema, pneumonitis, or ARDS. Discontinue if unexplained dyspnea occurs.
• Hemolytic Uremic Syndrome (HUS): Rare but fatal kidney failure with microangiopathic hemolytic anemia. Monitor renal function closely.
• Liver Toxicity: Transient elevation of liver enzymes is common.

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 Sterile 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.