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Description
PRODUCT DESCRIPTION:
Estradiol + Dydrogesterone Tablets offer a clinically proven sequential combination hormone replacement therapy (HRT) for postmenopausal women with an intact uterus. This formulation combines Estradiol, a natural estrogen, with Dydrogesterone, a highly selective oral progestogen, to ensure endometrial protection while relieving menopausal symptoms.
The unique balance of estrogen and progestin makes this product ideal for managing vasomotor symptoms, urogenital atrophy, and osteoporosis prevention in postmenopausal women, while minimizing the risks associated with unopposed estrogen therapy.
Formulation & Presentation:
- Dosage Form: Tablets
- Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
- Available Strengths:
- Estradiol 1 MG + Dydrogesterone 10 MG
- Estradiol 2 MG + Dydrogesterone 10 MG
- Route of Administration: Oral (As per physician’s discretion or therapeutic indication)
Therapeutic Indications:
- Management of moderate to severe vasomotor symptoms associated with menopause (hot flashes, night sweats)
- Treatment of urogenital atrophy
- Prevention of postmenopausal osteoporosis in high-risk women
- Hormonal support in women with premature ovarian insufficiency or surgical menopause
- Endometrial protection in estrogen therapy
Side Effects:
- COMMON: Breast tenderness, Headache, Nausea, Vaginal bleeding or spotting, Abdominal cramps
- SERIOUS (RARE): Deep vein thrombosis or pulmonary embolism, Endometrial or breast cancer (long-term unmonitored use), Stroke or myocardial infarction, Liver function abnormalities, Mood changes or depression
- PRECAUTIONS: Not to be used in women with a history of hormone-dependent cancers, active liver disease, or thromboembolic disorders
- Regular monitoring advised during long-term HRT
- Should be prescribed only after individual risk-benefit assessment
- Not intended for use during pregnancy or lactation
- Use caution in patients with hypertension, diabetes, epilepsy, or asthma
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TECHNICAL INFORMATION
Product Specifications:
- HSN Code: To be assigned per international classification standards
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: 15x1x8 CMS
- Shelf Life (Subject To Country Specific Guidelines): 24 months from date of manufacture or as per label specifications
- Storage: Store below 25°C. Protect from moisture and direct sunlight.
Regulatory Status & Supply Information:
- Regulatory Status: WHO-GMP Complaint Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- Stability: Zone IVB Compliant
- MOQ: Negotiable. Based on market & registration status
- Export Options: Available for private label, institutional supply, or branded export
Who Should Source This Product?
- Importers and distributors in women’s health and hormone therapy portfolios
- Gynecology clinics and menopause management centers
- Hospitals and wellness programs targeting postmenopausal care
- Government and institutional buyers involved in osteoporosis and menopause-related health initiatives
- Partners supplying to regulated markets requiring endometrial-safe HRT combinations
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration support in
- Trusted consortium network, simplifying India’s complex pharma supply chain
- Multiple approved manufacturers for best fit in import country
- Network of audited, compliant manufacturers across India
- Customizable & Flexible branding, packaging & formulation flexibility
- End to End Logistics support flexibility & support
- Deep expertise in exporting specialty injectables & ART products
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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