Bicalutamide Tablets

Description

Bicalutamide Film-Coated Tablets (50 mg / 150 mg)

Healthy Inc is a specialized global supplier and exporter of advanced oncology, urology, and targeted high-containment endocrine therapeutics. We provide ultra-high-purity, kinetically optimized Bicalutamide Tablets, manufactured in WHO–GMP certified, strictly segregated high-containment oncology facilities. This “Non-Steroidal Anti-Androgen” is a massive-volume strategic export to urology hospitals, cancer centers, and government health ministries, serving as the globally mandated intervention for Metastatic Prostate Cancer and locally advanced disease.

Product Overview

This formulation operates as a biochemical “Androgen Shield.” Since prostate cancer cells are often “fed” by testosterone, Bicalutamide is engineered to physically block the fuel source, slowing or stopping the growth of the tumor.

• Mechanism 1 (Competitive Receptor Blockade): Bicalutamide binds with high affinity to the Androgen Receptors (AR) on the surface of prostate cancer cells. By occupying these sites, it prevents natural hormones like Testosterone and Dihydrotestosterone (DHT) from binding and triggering cell growth.

• Mechanism 2 (Inhibition of Gene Expression): Once bound to the receptor, Bicalutamide prevents the receptor from moving into the cell nucleus. This halts the “transcription” of genes that promote cancer cell division and survival.

• Mechanism 3 (The Kinetic Advantage): Bicalutamide has a long half-life (approx. 6 days), which ensures a stable, steady-state concentration in the blood with simple Once-Daily Dosing, improving patient compliance in long-term therapy.

Product Composition & Strength

We supply this product as a Precision-Blended, Cytotoxic Tablet, packed in high-barrier Alu-Alu blister strips to ensure the stability of the active API.

Technical & Logistics Specifications

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

• CAS Number: 90357-06-5 (Bicalutamide)

   

• Dosage Form: Film-Coated Tablet

   

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

Manufacturing Authority & Compliance

• OEB 4 High-Containment: Bicalutamide is a potent hormonal antineoplastic. Our facility utilizes Dedicated Oncology Blocks with negative pressure environments and primary containment to ensure zero cross-contamination and maximum safety for the production team.

• Polymorph Stability: We monitor the crystalline form of Bicalutamide during manufacturing to ensure the most stable polymorph is used, guaranteeing predictable dissolution and 100% bioequivalence to the innovator brand (Casodex).

Primary Indications

• Urology/Oncology: Treatment of advanced (metastatic) prostate cancer in combination with surgical or chemical castration.

• Monotherapy: Management of locally advanced prostate cancer as an alternative to radical surgery or radiotherapy.

   

Dosage & Administration

• Standard Dosing: 50 mg or 150 mg once daily, taken at the same time every day.

   

• Administration: Can be taken with or without food.

Safety Warning: Hepatotoxicity Risk. Periodic liver function tests (LFTs) are mandatory during treatment. Potential side effects include gynecomastia (breast enlargement) and hot flashes due to the androgen blockade. Strictly contraindicated in females and children.

 

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-end Oncology Therapeutics. Whether you are a Urology Specialist Network in Africa or a B2B Pharma Marketplace partner in the CIS, we ensure secure, WHO-GMP compliant delivery.