Description

Tamoxifen Citrate 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, pharmacopeially validated Tamoxifen Citrate Tablets (10 mg / 20 mg), manufactured in WHO–GMP certified, strictly dedicated 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 and specialized gynecological protocols.

Product Overview

This formulation contains Tamoxifen Citrate, the highly stable, globally standardized salt form of the non-steroidal antiestrogen. It acts as a targeted hormone therapy, depriving hormone-receptor-positive breast cancer cells of the estrogen they require for tumor proliferation.

The “ER+ Breast Cancer & SERM” Specialist:

• Mechanism (The SERM Blockade): Tamoxifen Citrate is a Selective Estrogen Receptor Modulator. In breast tissue, it acts as a strict antagonist, forcefully binding to the estrogen receptors on the cancer cells. This physical shield blocks endogenous estrogen from attaching to the cell, arresting the tumor cell cycle in the G0/G1 phase and halting tumor progression.
• The Citrate Salt Advantage: Formulating Tamoxifen as a citrate salt ensures superior gastrointestinal solubility and reliable systemic absorption compared to the free base. Once absorbed, the liver converts it into its highly potent active metabolites (primarily endoxifen), which possess up to 100 times greater affinity for the estrogen receptor than Tamoxifen itself.
• The Agonist Paradox (Bone & Lipid Benefits): While it blocks estrogen in the breast, Tamoxifen Citrate uniquely acts as an estrogen agonist (mimicking estrogen) in other tissues. It actively helps prevent bone mineral density loss (osteoporosis) and lowers total cholesterol levels in postmenopausal women during long-term maintenance therapy.

Product Composition & Strength

We supply this product as a Precision-Blended 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.

*Pack Sizes: 10×10 Blisters or HDPE Bottles of 30/100 (Optimized specifically for strict, 5-to-10-year oncology adherence regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Oncology Distributors, and Women’s Health NGOs.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Dedicated Hormonal Containment (CRITICAL COMPLIANCE): Because Tamoxifen Citrate is a potent hormonal modulator, 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 conditions:

• 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 Gynecology (Ovulation Induction): Frequently utilized by fertility specialists to induce ovulation in women with anovulatory disorders (such as PCOS) as a highly effective alternative to Clomiphene.

Dosage & Administration

Recommended Dosage (Strictly as per Board-Certified Oncologist/Gynecologist):

• Standard Adult Oncology 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 potentially fatal uterine malignancies (endometrial cancer or uterine sarcoma). Women must be rigorously monitored for abnormal vaginal bleeding.
• BLACK BOX WARNING (Thromboembolic Events): Tamoxifen Citrate 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): Co-administration with strong CYP2D6 inhibitors—specifically common antidepressants like Fluoxetine, Paroxetine, or Bupropion—will block the liver from converting Tamoxifen into its active metabolite, 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.