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Description
PRODUCT DESCRIPTION:
Testosterone Decanoate is a long-acting ester of testosterone designed for sustained androgen replacement therapy in males with confirmed testosterone deficiency.
Due to its extended half-life, it provides stable serum testosterone levels with infrequent dosing, making it an effective solution for improving compliance in long-term hormone therapy.
Formulated as an intramuscular oil-based injection, it is particularly suitable for large-scale therapeutic programs and specialty clinics managing hypogonadism and delayed puberty in males.
Formulation & Presentation:
- Dosage Form: Injectable Solution
- Presentation: Sterile, single-use ampoule or vial (customizable as per market demand)
- Available Strengths: 100 MG/mL and 250 MG/mL
- Route of Administration: Intramuscular Only (IM) or as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Testosterone replacement therapy in adult males with primary or secondary hypogonadism
- Supportive therapy in delayed puberty
- Potential use in transgender hormone therapy under medical supervision
- May be used in selected androgen-responsive metastatic breast cancers (as per oncologic protocols)
Side Effects:
- COMMON:
- Injection site pain or swelling
- Acne or oily skin
- Headaches
- Increased red blood cell count (polycythemia)
- SERIOUS (RARE):
- Gynecomastia
- Edema
- Liver function abnormalities
- Prostate enlargement or malignancy progression in predisposed individuals
- PRECAUTIONS:
- Not to be used in men with prostate or breast carcinoma
- Requires regular monitoring of hematocrit, testosterone levels, and PSA
- Use cautiously in patients with pre-existing cardiovascular, hepatic, or renal conditions
- Should be administered under medical supervision only
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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): 2 to 3 years under recommended storage conditions from date of manufacture or as per label specifications
- Storage: Oil-based injectable solution requiring cold-chain logistics (if specified by packaging). Protect from moisture and direct sunlight. The solution should be used strictly as per label guidelines.
Regulatory Status & Supply Information:
- Regulatory Status: WHO-GMP Complaint Manufacturing. Further certifications available on request
- Exports Ready Dossiers: Dossier Available (CTD/eCTD formats)
- Stability: Compliant
- MOQ: Negotiable. Based on market & registration status
- Export Options: Available for private label, institutional supply, or branded export
Who Should Source This Product?
- Testosterone Decanoate is ideal for pharmaceutical procurement agencies, public health authorities, hospital pharmacies, endocrine and andrology clinics, and B2B distributors involved in managing hormone replacement therapy.
- It is especially suited for export to LATAM, African, Middle Eastern, and South Asian markets where long-acting testosterone formulations are in demand for chronic endocrine care.
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 options
- End-to-end logistics flexibility & support
- Deep expertise in exporting specialty injectables & all products
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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