Dienogest Film-Coated Tablets (2 mg)
Healthy Inc is a specialized global supplier and exporter of advanced women’s health, reproductive endocrinology, and targeted high-containment fertility therapeutics. We provide ultra-high-purity, kinetically precise Dienogest Film-Coated Tablets (2 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 4/5) steroidal oral solid dosage facilities. This “Fourth-Generation Progestin & Endometriosis Modifier” is a massive-volume, highly lucrative export to gynecology networks, IVF (In Vitro Fertilization) centers, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line medical intervention for the long-term, definitive management of endometriosis and associated pelvic pain.
Product Overview
This highly advanced formulation operates as a highly specialized, targeted hormonal weapon. It is structurally unique—combining the pharmacological benefits of 19-nortestosterone derivatives with progesterone derivatives—to aggressively shrink rogue endometrial tissue without triggering the severe, masculinizing, or menopausal side effects of older therapies.
The “Endometriotic Lesion Atrophier & Progestin” Specialist:
- Mechanism 1 (The Localized Hypoestrogenic Effect): Endometriosis is an estrogen-dependent inflammatory disease. Dienogest exerts a profound negative feedback loop on the hypothalamic-pituitary-ovarian axis, moderately suppressing the endogenous production of estradiol. It drops estrogen to a “therapeutic window”—low enough to starve the endometriotic lesions, but high enough to prevent severe bone mineral density loss and hot flashes.
- Mechanism 2 (Direct Endometrial Atrophy): Dienogest creates a strictly hypergestagenic local environment. It binds directly to the progesterone receptors on the ectopic endometrial tissue, violently arresting cellular proliferation and physically forcing the lesions into a state of structural atrophy and apoptosis (programmed cell death).
- Mechanism 3 (The Anti-Androgenic & Anti-Inflammatory Synergy): Unlike older synthetic progestins (like Levonorgestrel), Dienogest possesses highly potent anti-androgenic properties. It does not cause acne, hirsutism (excess hair growth), or lipid profile destruction. Furthermore, it actively suppresses the secretion of inflammatory prostaglandins and cytokines in the pelvic cavity, rapidly crushing the agonizing pain associated with the disease.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Microdose 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 steroidal API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Dienogest USP/Ph.Eur. | 2 mg | The Global Endometriosis Standard: The definitive therapeutic micro-dose utilized globally for the continuous, long-term suppression of pelvic pain, dysmenorrhea, and dyspareunia caused by endometriosis. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Crospovidone / Povidone K-30 / Magnesium Stearate / Premium Polymeric Film | Diluent / Binder / Superdisintegrant / Lubricant / Heavy Film-Coating (Engineered specifically utilizing advanced multi-stage geometric dilution to ensure the 2mg steroidal payload is flawlessly uniform, finished with an opaque film-coat to seal the potent hormone safely away from factory handlers) |
*Pack Sizes: 14/28-Tablet Calendar Blisters (Optimized specifically for daily, uninterrupted, long-term gynecological dispensing).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Gynecology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.39.00 (Medicaments containing hormones – Progestogens) |
| CAS Number | 65928-58-7 (Dienogest) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Calendar-Printed Alu-PVC or Alu-Alu Blisters. Ensures strict daily compliance and protects the steroidal formulation from environmental humidity across 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 4/5 Steroidal Containment & Microgram Uniformity (CRITICAL COMPLIANCE): Dienogest is an exceptionally potent synthetic hormone. If standard generic facilities attempt to press this drug, airborne steroidal dust can cause severe endocrine disruption in factory workers and catastrophically cross-contaminate other non-hormonal batches. Our production takes place in dedicated, negative-pressure High-Containment Suites (OEB 4/5) utilizing closed-loop material transfer and terminal HEPA filtration. We guarantee absolute worker safety, zero cross-contamination, and strict clinical bioequivalence.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of chronic female reproductive disorders:
- Endometriosis: The primary, long-term medical management of endometriosis, rapidly alleviating pelvic pain, severe dysmenorrhea (menstrual cramps), and dyspareunia (painful intercourse), while structurally reducing endometriotic lesions.
Dosage & Administration
Recommended Dosage (Strictly as per Gynecologist Guidelines):
- Standard Adult Dosing: 2 mg taken orally once daily.
- The Continuous Therapy Mandate: Unlike cyclical birth control, Dienogest must be taken continuously every single day, without any pill-free breaks, regardless of vaginal bleeding. Treatment can be started on any day of the menstrual cycle.
- Not a Contraceptive: Although Dienogest inhibits ovulation, it is not officially approved as an oral contraceptive. Patients requiring contraception must be advised to use non-hormonal (barrier) methods during therapy.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Bleeding Pattern Alterations: The most common side effect is a profound change in the menstrual bleeding pattern. Patients frequently experience spotting, irregular bleeding, or eventually, complete amenorrhea (absence of menstruation). Patients must be heavily counseled that this is a normal, expected therapeutic effect, not a sign of danger.
- Venous Thromboembolism (VTE) Risk: As a progestogen, it carries a slightly increased epidemiological risk of deep vein thrombosis (DVT) and pulmonary embolism. It must be used with extreme caution in women with a history of severe cardiovascular disease or active blood clots.
- Hepatic Impairment: Strictly contraindicated in patients with presence or history of severe hepatic disease, as the hormone relies on liver enzymes for clearance.
- Bone Mineral Density (BMD) Monitoring in Adolescents: While safer than GnRH agonists, long-term use in adolescents (12-18 years) can cause a slight decrease in bone mineral density. Physicians must weigh the benefits of pain relief against the risk of reduced peak bone mass.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gynecology/IVF Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Synthetic Progestins, Endometriosis Therapeutics, and OEB 4/5 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for maternal health programs in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.