Leuprolide Acetate Depot
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Category: SKU: 00001-1
Leuprolide Acetate Depot

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Description

PRODUCT DESCRIPTION:

 

A long-acting synthetic GnRH agonist, Leuprolide Acetate Depot is used extensively in gynecology, endocrinology, and oncology. It treats hormone-sensitive conditions such as uterine fibroids, endometriosis, prostate cancer, and central precocious puberty (CPP). Its depot formulation allows sustained hormone suppression via controlled release.

 

Formulation & Presentation:

 

  • Dosage Form: Lyophilized Powder for Reconstitution
  • Presentation: Vial
  • Available Strengths: 3.75 mg, 7.5 mg, 11.25 mg, 22.5 mg

 

Route of Administration:

 

  • Sub-Cutaneous / Intramuscular (As per indication)

 

Therapeutic Indications:

 

  • Uterine Fibroids
  • Endometriosis
  • Prostate Cancer
  • Central Precocious Puberty (CPP)

 

Side Effects:

  • COMMON: Injection site discomfort, Hot flashes, headache, mood changes, decreased libido, fatigue.
  • SERIOUS (RARE): Osteoporosis, allergic reactions, cardiovascular symptoms, Bone density loss (long-term use)
  • PRECAUTIONS: Monitoring is advised in long-term therapy.

 

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TECHNICAL INFORMATION

Product Specifications:

  • HSN Code: 300439
  • Weight: Approx. 40g per vial (With Packaging)
  • Dimensions: 15x1x8 CMS
  • Shelf Life (Subject To Country Specific Guidelines): 24 months from date of manufacture
  • Storage: Store below 25°C. Protect from light. Do not freeze.

Regulatory Status & Supply Information:

  • Regulatory Status: USFDA/WHO-GMP Complaint Manufacturing. Further certifications available on request
  • Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
  • Zone IV Stability: Available
  • MOQ: Negotiable. Based on market & registration status

Who Should Source This Product?

  • SFDA Buyers looking for CPP treatments
  • Government tenders for gynecological therapies
  • Oncology distributors requiring long-acting formulations
  • Companies needing hormone-based depot injectables

Why Source from PHARMET?

  • Multiple approved manufacturers for best fit
  • Network of audited, compliant manufacturers across India
  • Export-ready documentation & regulatory support
  • Customizable packaging & formulation flexibility
  • Single-window sourcing for diverse pharma needs
  • Adaptable documentation support for effective registration support
  • Logistics support flexibility

CONTACT DETAILS:

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