Description
Norethisterone Tablets (5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced gynecological, endocrine, and reproductive health therapeutics. We provide ultra-high-purity, kinetically precise Norethisterone Uncoated / Film-Coated Tablets (5 mg), manufactured in WHO–GMP certified, highly segregated hormonal oral solid dosage facilities. This “Potent Synthetic Progestin” is a massive-volume, highly lucrative export to gynecology centers, family planning NGOs, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally trusted intervention for Dysfunctional Uterine Bleeding (DUB), Endometriosis, and severe Menorrhagia.
Product Overview
This highly advanced formulation contains Norethisterone (also known as Norethindrone), a powerful, first-generation synthetic progestogen that fundamentally regulates and stabilizes the female reproductive cycle, providing profound relief from erratic, heavy, and painful menstruation.
The “Endometrial Stabilizer & Cycle Regulator” Specialist:
Mechanism 1 (The Endometrial Transformation): In conditions like Dysfunctional Uterine Bleeding, a woman’s endometrium (uterine lining) grows excessively thick due to unopposed estrogen, leading to sudden, massive, and prolonged bleeding. Norethisterone violently interrupts this cycle. It binds directly to progesterone receptors, forcing the excessively grown (proliferative) endometrium to transition into a stable, non-growing (secretory) state. This physically halts the severe bleeding within 24 to 48 hours.
Mechanism 2 (The Withdrawal Reset): Once the patient completes the prescribed 10-to-14 day course of Norethisterone, the sudden drop in hormone levels triggers a controlled “withdrawal bleed.” This mimics a normal period, effectively shedding the old, erratic lining and completely resetting the patient’s menstrual cycle to a healthy baseline.
Mechanism 3 (The Endometriosis Suppressor): For patients with endometriosis (where uterine tissue grows agonizingly outside the uterus), high-dose, continuous Norethisterone suppresses the pituitary gland from releasing gonadotropins (FSH and LH). This shuts down ovarian estrogen production, starving the ectopic endometrial lesions, shrinking them, and providing profound, long-term pain relief.
Product Composition & Strength
We supply this product as a Precision-Blended Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the highly potent steroid hormone.
| Active Ingredient | Strength | Primary Clinical Function |
| Norethisterone Ph.Eur./USP | 5 mg | Global Gynecology Standard: High-dose therapeutic unit for acute hemorrhage cessation, endometriosis suppression, and menstrual cycle manipulation. |
| Excipients | Lactose Monohydrate / Maize Starch / Magnesium Stearate / Povidone K30 | Diluent / Binder / Lubricant (Engineered specifically for rapid gastric dissolution to halt acute uterine bleeding within 24-48 hours of the first dose) |
Pack Sizes: 10×10 Blisters or 3×10 Calendar Packs (Optimized specifically for strict cyclical gynecology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Gynecology Distributors, and Hospital Procurement Boards.
| Specification | Detail |
| HS Code | 3004.39.00 (Medicaments containing hormones but not antibiotics – Gynecology/Progestogens) |
| CAS Number | 68-22-4 (Norethisterone / Norethindrone) |
| Dosage Form | Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental degradation and ensures exact cyclical dosing across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Light and Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
Dedicated Hormonal Containment Engineering (CRITICAL COMPLIANCE): Steroid hormones are incredibly potent; even a microscopic fraction of a milligram can drastically alter human physiology. Standard pharmaceutical facilities cannot legally or safely manufacture them. Our production occurs in entirely segregated, multi-million-dollar Hormonal Blocks. We utilize strict negative-pressure cleanrooms, closed-loop powder transfer systems, and advanced multi-stage HEPA filtration. This absolutely guarantees zero cross-contamination with general medicines and provides complete occupational safety for our facility operators.
Therapeutic Indications (Human Use)
Indicated for the comprehensive, targeted management of severe female reproductive and menstrual dysfunction:
Dysfunctional Uterine Bleeding (DUB) & Menorrhagia: Rapid cessation of severe, prolonged, and erratic menstrual hemorrhage.
Endometriosis: Continuous therapy to suppress ovarian function, shrink ectopic endometrial tissue, and alleviate severe pelvic pain.
Primary Dysmenorrhea: Relief of severe, incapacitating menstrual cramps.
Postponement of Menstruation: Temporary delay of the menstrual cycle for surgical, athletic, or critical lifestyle necessities.
Premenstrual Syndrome (PMS): Management of severe cyclical physical and mood-based symptoms.
Dosage & Administration
Recommended Dosage (Strictly as per Gynecologist Guidelines):
Acute Uterine Bleeding: Typically 5 mg taken three times daily for 10 days. Bleeding usually stops within 24 to 48 hours. A withdrawal bleed will occur 2-4 days after completing the course.
Endometriosis: Initially 10 mg to 15 mg daily, continuously for 4 to 6 months to maintain absolute amenorrhea (absence of periods).
Postponement of Menstruation: 5 mg three times daily, starting strictly 3 days before the expected onset of menstruation.
Administration: Tablets must be swallowed whole with water, preferably at the exact same time each day to maintain stable hormone blood levels.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
Venous Thromboembolism (VTE) Risk: Like all systemic sex hormones, high-dose Norethisterone significantly increases the risk of dangerous blood clots, deep vein thrombosis (DVT), pulmonary embolism, and stroke. It is contraindicated in patients with a history of severe thrombotic disorders or severe uncontrolled hypertension.
Severe Hepatic Dysfunction: Contraindicated in patients with active liver disease, a history of severe hepatic adenomas, or severe pruritus (itching) during a previous pregnancy, as steroid hormones are heavily metabolized by and place significant strain on the liver.
Pregnancy (Absolute Contraindication): Must NEVER be used during suspected or confirmed pregnancy. High doses of synthetic progestins are heavily teratogenic and can cause severe masculinization (virilization) of a female fetus.
Sudden Vision Loss: Medication must be discontinued immediately if the patient experiences sudden partial or complete loss of vision, proptosis, or migraine with focal neurological symptoms.
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 Women’s Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gynecological and Hormonal Formulations. Whether you are looking for a reliable Government Tender Supplier for family planning clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly regulated, WHO-GMP certified products.









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