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Description
PRODUCT DESCRIPTION:
Cyproterone Acetate 50 MG Tablets are a powerful anti-androgen and progestational agent, widely used in the management of hormone-dependent conditions. Its primary mechanism involves blocking the action of male sex hormones (androgens) at target organs, making it an effective treatment in both androgen-related disorders in women and advanced prostate cancer in men.
It is commonly prescribed for severe acne, hirsutism, and androgenic alopecia in women and is a key agent in palliative care for prostate cancer in male patients. Cyproterone Acetate plays a vital role in endocrine regulation and gender transition therapies as well.
Formulation & Presentation:
- Dosage Form: Tablets
- Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
- Available Strengths: Cyproterone Acetate 50 MG Tablets
- Route of Administration: Oral (As per physician’s discretion or therapeutic indication)
Therapeutic Indications:
- Palliative treatment of advanced prostate carcinoma in men
- Management of severe hyperandrogenism in women (e.g., hirsutism, severe acne, androgenic alopecia)
- Adjunctive therapy in transgender hormone treatment (male-to-female transition)
- Control of sexual deviation in men (under strict medical supervision)
Side Effects:
- COMMON: Fatigue and tiredness, Weight changes, Decreased libido, Breast tenderness, Hot flashes, Nausea or mild gastrointestinal upset
- SERIOUS (RARE): Hepatotoxicity (requires regular liver function monitoring), Thromboembolic events, Depression or mood alterations, Gynecomastia in men, Changes in liver enzymes or cholesterol levels
- PRECAUTIONS: Contraindicated in patients with active liver disease, history of thromboembolism, or hormone-sensitive malignancies (unless indicated)
- Not recommended during pregnancy or lactation
- Regular liver function and hormonal monitoring advised during long-term use
- Caution in diabetic patients and those with cardiovascular risksShould only be prescribed under specialist supervision
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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 or as per label specifications
- Storage: Store below 25°C. Protect from moisture and direct sunlight.
Regulatory Status & Supply Information:
- Regulatory Status: 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?
- Oncology and urology distributors seeking hormonal treatments for prostate cancer
- Importers supplying dermatology and gynecology clinics treating hyperandrogenic conditions
- Institutions offering gender-affirming hormone therapy
- Government and NGO-supported palliative care programs
- Buyers focused on niche hormonal and endocrine therapies
Why Source from PHARMET?
- Single-window sourcing for diverse pharma needs
- Export-ready documentation & regulatory support
- Adaptable documentation support for effective registration support in
- 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
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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