Description
Exemestane Film-Coated Tablets (25 mg)
Healthy Inc is a specialized global supplier and exporter of advanced high-containment oncology, endocrinology, and targeted antineoplastic therapeutics. We provide ultra-high-purity, kinetically precise Exemestane Film-Coated Tablets (25 mg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) steroidal oral solid dosage facilities. This “Irreversible Steroidal Aromatase Inactivator” is a massive-volume, highly critical export to breast cancer centers, oncological surgery networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, foundational adjuvant and advanced-stage intervention for Estrogen Receptor-Positive (ER+) Breast Cancer in postmenopausal women.
Product Overview
This highly advanced formulation operates as a devastating, targeted biochemical assassin. It does not merely block the enzyme responsible for creating estrogen; it chemically disguises itself, permanently binds to the enzyme, and destroys it, completely starving the breast cancer tumor of the hormones it needs to survive.
The “Suicide Inhibitor & Estrogen Depletion” Specialist:
- Mechanism 1 (The Irreversible Aromatase Inactivation): In postmenopausal women, the ovaries no longer produce estrogen. Instead, an enzyme called aromatase converts adrenal androgens (like androstenedione) into estrogen in the peripheral tissues and fat cells. Exemestane is a steroidal molecule structurally identical to the enzyme’s natural target. The aromatase enzyme mistakenly binds to Exemestane, which then triggers a chemical reaction that permanently and irreversibly destroys the enzyme (suicide inhibition).
- Mechanism 2 (Profound Systemic Estrogen Crash): Because the enzyme is destroyed, the body’s estrogen production plummets by up to 98% within days. The ER+ breast cancer cells, which rely entirely on estrogen to grow and multiply, are violently starved of their fuel source, forcing massive tumor regression and preventing microscopic cancer cells from triggering a relapse.
- The “Steroidal” Cross-Resistance Advantage: When a breast cancer tumor becomes resistant to standard non-steroidal AIs (like Letrozole), oncologists immediately pivot to Exemestane. Because Exemestane has a completely different steroidal structure, the tumor lacks cross-resistance. It is the ultimate backup weapon for maintaining cancer remission.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the potent steroidal antineoplastic agent.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Exemestane USP/Ph.Eur. | 25 mg | Global Adult Oncology Standard: The definitive daily maintenance dose required to maintain absolute, continuous destruction of peripheral aromatase enzymes and keep estrogen levels crashed. |
| Excipients | Mannitol / Copovidone / Crospovidone / Sodium Starch Glycolate / Magnesium Stearate / Premium Polymeric Film | Diluent / High-Shear Binder / Superdisintegrant / Surfactant / Heavy Film-Coating (Engineered specifically to lock the highly potent, teratogenic steroidal API safely inside the tablet, completely preventing handler and pharmacist exposure to the hazardous dust) |
*Pack Sizes: 10×10 Blisters or Bottles of 30 (Optimized specifically for strict 30-day chronic oncology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antineoplastics / Hormonal Therapies) |
| CAS Number | 107868-30-4 (Exemestane) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Ensures the physical integrity of the highly potent tablet and protects the steroidal formulation from degradation in Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- OEB 4 High-Containment & Steroidal Segregation (CRITICAL COMPLIANCE): Exemestane is a highly potent steroidal antineoplastic agent. Manufacturing this compound in standard generic facilities is strictly prohibited due to the severe risk of endocrine disruption in factory workers and the threat of cross-contaminating other drugs. Our production takes place in dedicated, negative-pressure High-Containment Isolator blocks (OEB 4) equipped with terminal HEPA filtration. We guarantee identical pharmacokinetic bioequivalence to the originator brand, ensuring that breast cancer patients maintain the exact plasma levels required for survival.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of hormone-dependent malignancies:
- Adjuvant Treatment of Early Breast Cancer: For postmenopausal women with estrogen-receptor positive (ER+) early breast cancer who have received two to three years of tamoxifen and are switched to Exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy.
- Advanced Breast Cancer: Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following antiestrogen therapy.
Dosage & Administration
Recommended Dosage (Strictly as per Oncologist Guidelines):
- Standard Adult Dosing: 25 mg taken orally once daily. Therapy is continued until tumor progression is evident (in advanced disease) or for the specified adjuvant duration (usually 2-3 years).
- Administration (The Mealtime Rule): Tablets MUST be administered after a meal. Plasma levels of Exemestane are increased by roughly 40% when the drug is taken after a high-fat meal compared to a fasting state, drastically improving clinical efficacy.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Osteoporosis & Severe Bone Fractures: By profoundly crashing estrogen levels, Exemestane violently accelerates bone density loss. Patients are at a highly elevated risk of severe osteoporosis and spontaneous fractures. Baseline bone mineral density (DEXA) scans and calcium/Vitamin D supplementation are mandatory.
- Premenopausal Contraindication (The Hormonal Paradox): Exemestane is strictly contraindicated in premenopausal women with functioning ovaries. If given to a premenopausal woman, the brain detects the lack of estrogen and triggers a massive counter-regulatory surge of gonadotropins, which will force the ovaries to produce even more estrogen, aggressively feeding the tumor.
- Pregnancy Category X (Absolute Contraindication): FATAL WARNING: Exemestane causes severe fetal harm. It must never be taken by women who are or may become pregnant.
- Severe Vasomotor Symptoms: The profound drop in estrogen will trigger severe, debilitating hot flashes, night sweats, and vaginal dryness in a massive percentage of patients.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antineoplastics, Steroidal Aromatase Inhibitors, and OEB 4 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for national breast cancer programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.








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