NORETHISTERONE ENANTHATE TABLETS
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NORETHISTERONE ENANTHATE TABLETS

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Description

PRODUCT DESCRIPTION:

 

Norethisterone Enanthate Tablets are a synthetic progestogen-based hormonal formulation widely used for menstrual cycle regulation, contraception, and treatment of hormone-related gynecological disorders.

These tablets offer potent and long-acting progestational effects, making them a preferred choice in low-resource settings where compliance and continuity are critical.

Formulation & Presentation:

  • Dosage Form: Oral Tablets
  • Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
  • Available Strengths: 200 MG Tablets

Route of Administration:

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

Therapeutic Indications:

  • Treatment of secondary amenorrhea
  • Management of endometriosis
  • Hormonal contraception (in specific regimens)
  • Dysfunctional uterine bleeding
  • Part of hormone replacement therapy protocols

Side Effects:

  • COMMON: Headache, Breast tenderness, Nausea, Mood swings, Weight changes
  • SERIOUS (RARE): Thromboembolic events, Liver dysfunction, Vision disturbances, Severe allergic reactions
  • PRECAUTIONS: Not recommended for patients with active thrombotic disorders
    • Use with caution in liver impairment and hormone-sensitive malignancies
    • Should not be used during pregnancy unless clearly needed

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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?

  • Government Family Planning Programs
  • NGOs and Women’s Health Initiatives
  • Hospitals & Gynecology Clinics
  • Distributors Specializing in Hormonal & Reproductive Health
  • Clinical Research Organizations (CROs)

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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