Capecitabine Tablets

Healthy Inc is a specialized global supplier and exporter of advanced oncology, internal medicine, and targeted high-containment cytotoxic therapeutics. We provide ultra-high-purity, kinetically stabilized Capecitabine Tablets (150 mg / 500 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 5) oncology oral solid dosage facilities. This “Oral Fluoropyrimidine Carbamate Prodrug” is a massive-volume, highly strategic export to oncology hospitals, colorectal cancer networks, and government health ministries, serving as the globally mandated intervention for Colorectal, Breast, and Gastric cancers.

Product Overview

This formulation operates as a sophisticated “Trojan Horse.” Capecitabine itself is non-cytotoxic, but it undergoes a unique three-step enzymatic conversion process that culminates inside the tumor tissue, where it transforms into the active cancer-killing agent, 5-Fluorouracil (5-FU)

 

  • Mechanism 1 (Tumor-Selective Activation): The final step of conversion is catalyzed by the enzyme Thymidine Phosphorylase (TP). Since TP levels are significantly higher in tumor tissues than in healthy tissues, the active drug is concentrated within the cancer cells, minimizing systemic “Total Body” toxicity.

  • Mechanism 2 (Thymidylate Synthase Inhibition): Once active, the drug’s metabolite binds to the enzyme Thymidylate Synthase (TS). This physically blocks the synthesis of thymidine triphosphate, an essential building block for DNA replication.

  • Mechanism 3 (RNA & DNA Sabotage): The metabolites are also mistakenly incorporated into RNA and DNA strands. This “structural fraud” triggers cellular error-response mechanisms that lead to programmed cell death (Apoptosis) of the malignant cell.

Technical & Logistics Specifications

  • HS Code: 3004.90.99 (Medicaments containing other active substances – Oncology/Antineoplastics)

  • CAS Number: 154361-50-9 (Capecitabine)

  • Dosage Form: Film-Coated Tablet (Immediate Release)

  • Packaging: Alu-Alu Blisters. Protects the sensitive API from light and environmental humidity across Zone IVb tropical climates.


Manufacturing Authority & Compliance

  • OEB 5 High-Containment: Capecitabine is a potent cytotoxic agent. Our facility utilizes Negative Pressure Isolators and Dedicated Oncology Lines to prevent cross-contamination and ensure the highest safety for our production team and the environment.

  • Solubility Mastery: We utilize advanced granulation techniques to manage the massive 500mg payload, ensuring rapid disintegration and consistent absorption to match the innovator brand’s pharmacokinetic profile.

Dosage & Administration

  • Standard Dosing: Typically $1250 \text{ mg/m}^2$ administered orally twice daily (morning and evening) for 14 days, followed by a 7-day rest period.

  • The “30-Minute Rule” (CRITICAL): Tablets MUST be swallowed with water within 30 minutes after a meal. Food is essential to modulate the absorption and reduce gastrointestinal irritation.

  • Do Not Crush: Tablets must be swallowed whole. Breaking or crushing tablets creates a hazardous cytotoxic dust risk for caregivers.

Safety Warning: Strictly contraindicated in patients with known DPD (Dihydropyrimidine Dehydrogenase) deficiency, as this can lead to life-threatening toxicity. Monitor for Hand-Foot Syndrome (redness/swelling of palms and soles) and severe diarrhea.


Global Export & Contract Manufacturing

Healthy Inc is a premier Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-containment Antineoplastics. Whether you are a Government Tender Supplier for oncology programs in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.

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