NORETHISTERONE SUSTAINED RELEASE 5 MG TABLETS
Categories:, , SKU: 00010-10
NORETHISTERONE SUSTAINED RELEASE 5 MG TABLETS

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Description

PRODUCT DESCRIPTION:

 

Norethisterone Sustained Release 5 MG Tablets offer a controlled-release progestin formulation for consistent therapeutic effects in the management of menstrual disorders. Designed for once-daily convenience and prolonged hormonal support, this formulation is ideal for treating dysfunctional uterine bleeding, endometriosis, and delaying menstruation.

The sustained release mechanism ensures a stable plasma level, reducing dosing frequency and enhancing compliance.

Formulation & Presentation:

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

Route of Administration: Oral (As per clinical therapeutic indication and treatment protocol)

Therapeutic Indications:

  • Oral (As per clinical therapeutic indication and treatment protocol)
  • Dysfunctional uterine bleeding
  • Irregular or heavy periods
  • Endometriosis
  • Premenstrual syndrome (PMS)
  • Delay of menstruation
  • Secondary amenorrhea

Side Effects:

  • COMMON: Nausea, Mild headache, Breast tenderness, Mood changes, Fatigue
  • SERIOUS (RARE): Blood clotting disorders, Visual disturbances, Hepatic dysfunction
  • PRECAUTIONS: Not to be used during pregnancy or in patients with hormone-sensitive cancers
    • Use cautiously in women with a history of thromboembolic events or liver disease
    • Long-term users should be monitored for liver function and cardiovascular risk factors

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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?

  • Gynecology Clinics & Women’s Wellness Chains
  • Government Health Departments
  • Public-Private Health Missions
  • B2B Distributors Focused on Hormonal Therapeutics
  • Hospital Pharmacies & Multi-specialty Clinics

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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