NORETHISTERONE 50 MG + ESTRADIOL VALERATE 5 MG TABLETS
Categories:, , SKU: 00008-8
NORETHISTERONE 50 MG + ESTRADIOL VALERATE 5 MG TABLETS

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Description

PRODUCT DESCRIPTION:

 

This combination of Norethisterone, a synthetic progestin, and Estradiol Valerate, an estrogen derivative, is designed to offer dual-action hormonal support for the management of menstrual irregularities, dysfunctional uterine bleeding, and hormone replacement in peri- and postmenopausal women.

The formulation mimics natural hormonal cycles, offering therapeutic control and cycle regularity with predictable safety outcomes.

Formulation & Presentation:

  • Dosage Form: Oral Tablets
  • Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
  • Available Strengths: 50 MG + 5 MG Tablets

Route of Administration:

  • Oral (As per clinical therapeutic indication and treatment protocol)

Therapeutic Indications:

  • Breast tenderness,
  • Headache,
  • Nausea
  • Fluid retention
  • Mood fluctuations

Side Effects:

  • COMMON: Breast tenderness, Headache, Nausea, Fluid retention, Mood fluctuations
  • SERIOUS (RARE): Thromboembolic events, Hepatic dysfunction, Visual disturbances, Hypertension or gallbladder disorders
  • PRECAUTIONS: Not indicated during pregnancy
    • Caution in patients with liver impairment, thrombotic disorders, or hormone-sensitive malignancies
    • Regular monitoring advised during long-term use

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: 30049099
  • 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?

  • Gynecology & Women’s Health Clinics: For managing menstrual disorders, HRT, and hormone-sensitive conditions
  • Government Reproductive Health Programs: As part of women’s hormonal wellness kits
  • NGOs & Public Health Missions: Addressing cycle regulation and hormone imbalance in underserved populations
  • B2B Distributors Focused on Women’s Wellness: A critical addition to hormonal therapy portfolios
  • Hospital Pharmacies & Specialty Chains: For advanced cycle control and estrogen-progestin therapy requirements

Why Source from PHARMET?

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