Description

Abiraterone Acetate Tablets (250 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced oncology, urology, and targeted high-containment therapeutics. We provide ultra-high-purity, kinetically optimized Abiraterone Acetate Tablets, manufactured in WHO–GMP certified, strictly segregated high-containment oncology facilities. This “Selective CYP17 Enzyme Inhibitor” is a premium strategic export to cancer research hospitals, specialized urology clinics, and government health ministries, serving as the globally mandated intervention for Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Product Overview

This formulation operates as a “Chemical Shutdown System.” Prostate cancer cells usually “feed” on testosterone. Abiraterone blocks the body’s ability to make this fuel, even in the smallest amounts.

• Mechanism 1 (Irreversible CYP17 Inhibition): Abiraterone irreversibly inhibits the enzyme $17\alpha$-hydroxylase/C17,20-lyase (CYP17). This enzyme is required for the synthesis of androgens (testosterone) in the body.

• Mechanism 2 (Triple-Source Blockade): Unlike surgical castration or LH-RH analogs that only affect the testes, Abiraterone stops androgen production in the Testes, Adrenal Glands, and the Prostate Tumor itself.

• Mechanism 3 (Metastatic Control): By reducing serum testosterone to undetectable levels, it physically shrinks the tumor and slows the progression of bone metastases, significantly improving overall survival rates.

 Technical & Logistics Specifications

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

• CAS Number: 154229-18-2 (Abiraterone Acetate)

• Dosage Form: Uncoated or Film-Coated Tablet

• Packaging: High-Density Polyethylene (HDPE) Bottles with child-resistant caps or Alu-Alu Blisters. Our moisture-lock packaging ensures 24-month stability in Zone IVb tropical climates.

Manufacturing Authority & Compliance

• OEB 5 High-Containment: Abiraterone is a highly potent hormonal agent. Our facility utilizes Dedicated Oncology Blocks with isolator technology and negative pressure to ensure zero cross-contamination.

• Micronization Precision: To ensure consistent clinical results, we utilize Jet-Milling Micronization to achieve a specific particle size distribution, which is critical for the drug’s absorption and efficacy.

Primary Indications

• Oncology: Treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have received prior chemotherapy.

• Urology: Treatment of newly diagnosed high-risk metastatic castration-sensitive prostate cancer (mCSPC).

• Combination Therapy: Strictly indicated for use in combination with Prednisolone or Prednisone.

  Dosage & Administration

• Standard Adult Dosing: 1,000 mg (two 500 mg tablets or four 250 mg tablets) once daily.

• Administration: Must be taken on an empty stomach. No food should be consumed for at least 2 hours before and at least 1 hour after the dose. Taking it with food can cause a 10-fold increase in absorption, leading to toxicity.

Safety Warning: Mineralocorticoid Excess. Blocking CYP17 can cause high blood pressure, fluid retention, and low potassium. MANDATORY: Must be taken with a corticosteroid (Prednisone) to prevent these effects. Monitor Liver Function Tests (LFTs) every two weeks for the first three months of treatment.

Global Export & Contract Manufacturing

Healthy Inc is a premier Oncology Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end targeted hormonal therapies. Whether you are a National Cancer Program in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.