Tamoxifen Tablets (10 mg / 20 mg)
Healthy Inc is a specialized global supplier and exporter of advanced oncology, women’s health, and antineoplastic therapeutics. We provide ultra-high-purity, kinetically precise Tamoxifen Citrate Tablets (10 mg / 20 mg), manufactured in WHO–GMP certified, strictly isolated hormonal and oncology oral solid dosage facilities. This “Selective Estrogen Receptor Modulator (SERM)” is a massive-volume, high-priority export to comprehensive cancer centers, breast cancer NGOs, outpatient oncology networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, life-saving intervention for ER-positive breast cancer.
Product Overview
This formulation contains Tamoxifen (as Tamoxifen Citrate), a groundbreaking non-steroidal antiestrogen that acts as a targeted hormone therapy, depriving hormone-receptor-positive breast cancer cells of the estrogen they need to grow and multiply.
The “ER+ Breast Cancer Eradicator” Specialist:
- Mechanism (The SERM Blockade): Tamoxifen is a Selective Estrogen Receptor Modulator. In breast tissue, it acts as a strict antagonist. It forcefully binds to the estrogen receptors on the cancer cells, creating a physical shield. When the body’s natural estrogen tries to attach to the cell to signal it to divide and grow, it is blocked. Starved of this growth signal, the tumor cell cycle is arrested in the G0/G1 phase, halting tumor progression.
- The 5-to-10 Year Maintenance Standard: For women who have undergone surgery, radiation, or chemotherapy for early-stage ER+ breast cancer, taking daily oral Tamoxifen for 5 to 10 years is the globally mandated adjuvant therapy. It drastically reduces the risk of the cancer returning (recurrence) and massively improves long-term survival rates.
- The Agonist Paradox (Bone & Lipid Benefits): While it blocks estrogen in the breast, it uniquely acts as an estrogen agonist (mimicking estrogen) in other parts of the body. It actively helps prevent bone loss (osteoporosis) and lowers cholesterol levels in postmenopausal women, providing significant secondary health benefits during long-term therapy.
Product Composition & Strength
We supply this product as a Precision-Blended Uncoated or Film-Coated Tablet, packed in highly secure, moisture-resistant Alu-PVC or opaque Alu-Alu blister strips to preserve the integrity of the highly sensitive hormonal API.
| Active Ingredient | Strength | Primary Clinical Use |
|---|---|---|
| Tamoxifen Citrate USP/Ph.Eur. | 10 mg | Standard divided-dose therapy and specific risk-reduction protocols. |
| Tamoxifen Citrate USP/Ph.Eur. | 20 mg | Global Standard: Target once-daily adult maintenance dose for ER+ breast cancer. |
| Excipients | Mannitol / Maize Starch / Magnesium Stearate / Croscarmellose Sodium | Diluent / Superdisintegrant (Engineered for immediate gastric dispersion and reliable absorption) |
*Pack Sizes: 10×10 Blisters or Bottles of 30/100 (Optimized specifically for strict, multi-year oncology adherence regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Oncology Distributors, and Women’s Health NGOs.
| HS Code | 3004.90.99 / 3004.39.00 (Medicaments containing hormones/antineoplastic agents) |
| CAS Number | 54965-24-1 (Tamoxifen Citrate) |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | Alu-PVC or Alu-Alu Blisters. Protects the formulation from light and humidity, ensuring a stable, multi-year shelf life. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dedicated Hormonal Containment (CRITICAL COMPLIANCE): Because Tamoxifen is a potent hormonal modulator and antineoplastic agent, its manufacturing must never occur on standard generic production lines. Our manufacturing is executed within strictly segregated, highly controlled hormonal blocks operating under negative pressure with multi-stage HEPA filtration, fully satisfying the stringent requirements of international health ministries to prevent cross-contamination.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management and prevention of hormone-dependent malignancies:
- Breast Cancer Treatment: Adjuvant treatment of node-positive and node-negative estrogen receptor-positive (ER+) breast cancer in women and men. Treatment of metastatic breast cancer.
- Breast Cancer Risk Reduction: Prophylactic reduction in the incidence of breast cancer in women at high risk for the disease.
- Off-Label Use: Frequently used in gynecology and fertility clinics to induce ovulation in women with anovulatory disorders (similar to Clomiphene).
Dosage & Administration
Recommended Dosage (Strictly as per Board-Certified Oncologist):
- Standard Adult Dosing: For breast cancer patients, the recommended daily dose is 20 mg. Doses greater than 20 mg per day should be given in divided doses (e.g., 10 mg twice daily).
- Administration: Must be taken orally. Can be taken with or without food.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Uterine Malignancies): Because Tamoxifen acts as an estrogen agonist in the uterus, it significantly increases the risk of endometrial changes, including hyperplasia, polyps, and potentially fatal uterine malignancies (endometrial cancer or uterine sarcoma). Women must be rigorously monitored for abnormal vaginal bleeding.
- BLACK BOX WARNING (Thromboembolic Events): Tamoxifen significantly increases the risk of serious and potentially fatal blood clots, including Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and stroke. It is strictly contraindicated in women who require concurrent coumarin-type anticoagulant therapy or who have a history of DVT/PE.
- CYP2D6 Interaction (CRITICAL): Tamoxifen is a “prodrug” that must be converted by the liver enzyme CYP2D6 into its active form (endoxifen). Co-administration with strong CYP2D6 inhibitors—specifically common antidepressants like Fluoxetine, Paroxetine, or Bupropion—will block this activation, rendering the breast cancer treatment completely ineffective.
- Teratogenicity: Can cause fetal harm. Women of childbearing potential must use highly effective, non-hormonal contraception during therapy and for 2 months after stopping the drug.
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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Oncology and Hormonal Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for breast cancer initiatives 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.