Ethinylestradiol Tablets (0.05 mg / 1 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, high-containment women’s health, and palliative oncology therapeutics. We provide ultra-high-purity, kinetically precise Ethinylestradiol Film-Coated Tablets (0.05 mg / 1 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 5) steroidal oral solid dosage facilities. This “High-Potency Synthetic Estrogen” is a targeted, specialized export to endocrine clinics, palliative oncology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as a highly potent intervention for severe estrogen deficiency, female hypogonadism, and the palliative management of advanced, inoperable prostate and breast carcinomas.
Product Overview
This highly advanced formulation operates as a profound, systemic endocrine manipulator. Ethinylestradiol is structurally engineered with an ethinyl group at the C17 position, making it massively more potent and resistant to liver metabolism than natural estradiol. It floods the body with estrogenic signals, fundamentally altering tissue growth and shutting down endogenous hormone production loops.
The “Potent ER Agonist & Gonadotropin Suppressor” Specialist:
- Mechanism 1 (The Estrogen Receptor Agonism): Ethinylestradiol diffuses passively into target cells and violently binds to intracellular Estrogen Receptors (ER alpha and beta). The receptor-hormone complex enters the nucleus and binds to specific DNA sequences (Estrogen Response Elements), triggering massive genomic transcription. This restores vital estrogenic functions in women suffering from severe ovarian failure, regulating bone density, lipid profiles, and the maintenance of the female reproductive tract.
- Mechanism 2 (The Palliative Oncology Loophole – Prostate Cancer): In men with advanced, inoperable prostate cancer, massive doses of estrogen act as a chemical castration agent. The synthetic estrogen exerts profound negative feedback on the hypothalamus and pituitary gland, instantly shutting down the release of Luteinizing Hormone (LH). Without LH, the testicles completely stop producing testosterone, starving the androgen-dependent prostate cancer cells of their fuel.
- The “Hepatic First-Pass” Supremacy: Natural estrogens are almost completely destroyed by the liver when taken orally. The ethinyl substitution in Ethinylestradiol creates an impenetrable chemical shield, allowing it to survive the liver’s “first-pass” metabolism. This results in extreme oral bioavailability and potency—requiring microscopic doses (mcg) for systemic effects.
Product Composition & Strength
We supply this product as a Precision-Blended, Hazard-Shielded 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 synthetic steroidal API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Ethinylestradiol USP/Ph.Eur. | 0.05 mg (50 mcg) | The Endocrinology Standard: The definitive micro-dose engineered specifically for female hypogonadism, primary ovarian failure, and strictly monitored estrogen replacement. |
| Ethinylestradiol USP/Ph.Eur. | 1 mg | The Palliative Oncology Macrodose: Massive therapeutic payload utilized strictly for the aggressive hormonal suppression of advanced, inoperable prostate or breast cancer. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K-30 / Magnesium Stearate / Premium Polymeric Film | Diluent / Binder / Superdisintegrant / Lubricant / Heavy Film-Coating (Engineered specifically to form an impenetrable physical barrier over the tablet core. This completely seals the potent steroidal API, ensuring absolute safety for handlers and guaranteeing zero cross-contamination in the facility) |
*Pack Sizes: 10×10 Blisters or Bottles of 100 (Optimized specifically for strict chronic endocrine and oncology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.39.00 (Medicaments containing hormones – Synthetic Estrogens) |
| CAS Number | 57-63-6 (Ethinylestradiol) |
| 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 across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- OEB 5 Absolute Containment (CRITICAL COMPLIANCE): Ethinylestradiol is one of the most potent synthetic hormones in existence. If standard generic facilities attempt to press this drug, airborne dust will cause severe feminization in male factory workers and catastrophically contaminate other pharmaceutical batches. Our production takes place in dedicated, negative-pressure maximum-containment suites (OEB 5) utilizing closed-loop material transfer and terminal HEPA filtration. We guarantee absolute worker safety and flawless 0.05mg content uniformity.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of profound estrogen deficiency and endocrine-responsive malignancies:
- Female Hypogonadism & Ovarian Failure: Replacement therapy in conditions where the ovaries fail to produce endogenous estrogen (e.g., Turner syndrome, primary ovarian insufficiency).
- Palliative Oncology (Prostate Cancer): Palliation of advanced, inoperable prostate cancer in men by chemically suppressing testicular androgen production.
- Palliative Oncology (Breast Cancer): Palliation of appropriately selected cases of inoperable, progressing breast cancer in postmenopausal women.
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist / Oncologist Guidelines):
- Hypogonadism (Female): Typically 0.05 mg one to three times daily during the first two weeks of a theoretical menstrual cycle, followed by the addition of a progestin for the last half of the cycle.
- Palliative Prostate Cancer (Male): Typically 0.15 mg to 2.0 mg daily, given in divided doses.
- Palliative Breast Cancer (Female): Typically 1 mg three times daily for chronic palliation.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Endometrial Cancer Risk): The use of unopposed estrogen (Ethinylestradiol without a balancing progestin) in a woman with an intact uterus massively increases the risk of endometrial cancer. A progestin must ALWAYS be co-prescribed to induce shedding of the uterine lining.
- Severe Venous Thromboembolism (FATAL WARNING): Synthetic estrogens violently alter the liver’s production of clotting factors. This drug massively increases the risk of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Myocardial Infarction, and Ischemic Stroke, especially in heavy smokers or patients with a history of clotting disorders.
- Hypercalcemia in Breast Cancer: In patients with breast cancer and bone metastases, severe, potentially fatal hypercalcemia (calcium spikes) can occur.
- Hepatic Adenomas & Toxicity: High doses are heavily metabolized by the liver and can cause benign hepatic adenomas, which may rupture and cause fatal intra-abdominal hemorrhage.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Endocrinology/Oncology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Synthetic Hormones, Palliative Antineoplastics, and OEB 5 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for oncology wards in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.