ESTRADIOL HEMIHYDRATE TABLETS
Categories:, SKU: 00012-12
ESTRADIOL HEMIHYDRATE TABLETS

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Description

PRODUCT DESCRIPTION:

 

Estradiol Hemihydrate Tablets are a synthetic form of the naturally occurring female hormone estrogen. These tablets are primarily prescribed for the management of estrogen deficiency symptoms in postmenopausal women and other hormone-related conditions.

With precision dosing and reliable formulation, they help maintain hormonal balance, support bone density, and alleviate menopausal discomfort.

Formulation & Presentation:

  • Dosage Form: Tablets
  • Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
  • Available Strengths: As per market requirement (commonly 2.5 MG)

Route of Administration:

  • Oral (As per therapeutic indication)

Therapeutic Indications:

  • Hormone Replacement Therapy (HRT) for estrogen deficiency
  • Management of vasomotor symptoms associated with menopause (e.g., hot flashes)
  • Prevention of postmenopausal osteoporosis
  • Atrophic vaginitis and atrophic urethritis
  • Female hypogonadism and ovarian failure
  • Palliative treatment of advanced androgen-dependent prostate cancer in men (off-label)

Side Effects:

  • COMMON: Breast tenderness, Headache, Nausea, Bloating, Mood changes
  • SERIOUS (RARE): Thromboembolic disorders, Stroke, Myocardial infarction, Breast or endometrial cancer, Liver dysfunction
  • PRECAUTIONS: Contraindicated in individuals with undiagnosed vaginal bleeding, active thromboembolic disorders, or hormone-sensitive malignancies
    • Use with caution in patients with a history of cardiovascular disease, liver disorders, or migraines
    • Regular monitoring is recommended during long-term use
    • Not indicated during pregnancy or breastfeeding

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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
  • Storage: Store in a cool, dry place below 25°C. Protect from moisture and direct sunlight

Regulatory Status & Supply Information:

  • Regulatory Status: USFDA/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?

  • International pharmaceutical importers seeking high-quality hormonal therapies
  • Distributors catering to gynecology, endocrinology, and women’s health segments
  • Government and private healthcare procurement agencies focused on menopausal care and HRT
  • Tender participants requiring validated, cost-effective estrogen formulations
  • Institutional buyers looking for consistent supply and compliance-ready documentation

Why Source from PHARMET?

  • Single-window sourcing for diverse pharma needs
  • Export-ready documentation & regulatory support
  • Adaptable documentation support for effective registration support
  • 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

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