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Description
PRODUCT DESCRIPTION:
Drostanolone Propionate Injection is a synthetic anabolic-androgenic steroid (AAS) derived from dihydrotestosterone (DHT).
It is primarily utilized in clinical settings for the management of specific hormone-related conditions including advanced breast cancer in postmenopausal women.
Known for its androgenic properties with minimal estrogenic activity, it has also found restricted, controlled usage in certain medical and therapeutic research environments.
Formulated in a Pre-Filled Syringe (PFS), this preparation ensures sterility, convenience, and accurate dosage—meeting stringent global quality benchmarks.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 100 MG/ ML (Pre-Filled Syringe)
- Route of Administration: Intramuscular (IM). To be used in advanced clinical settings, as per clinical indication and severity. To be administered under supervision of a qualified specialist only. (As per physician’s discretion or decision)
Therapeutic Indications: Palliative treatment of hormone-sensitive metastatic breast cancer in postmenopausal women
- Investigational use in specific androgen-deficiency-related conditions (under regulatory oversight)
Note: Drostanolone is a controlled substance in many countries and should be used strictly in compliance with national regulatory guidelines.
Side Effects:
- COMMON:
- Localized pain or swelling at injection site
- Acne, oily skin, or hair loss
- Increased libido or mood changes
- SERIOUS (RARE):
- Hepatotoxicity or liver function alterations
- Virilization in female patients (voice deepening, hirsutism)
- Suppression of endogenous testosterone production
- Cardiovascular strain or lipid profile changes
- PRECAUTIONS:
- Not recommended during pregnancy or lactation
- Regular monitoring of liver function and hormone levels is advised
- Contraindicated in patients with prostate or male breast cancer
- Should be used only under prescription and clinical supervision
- Avoid in pediatric use and individuals with cardiovascular disease history
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TECHNICAL INFORMATION
Product Specifications:
- HSN Code: To be assigned per international classification standards & import jurisdiction
- Weight: Approx. 40g per Carton (With Packaging)
- Dimensions: (15x1x8 CMS)
- Shelf Life (Subject To Country Specific Guidelines): 24 to 36 months under recommended storage conditions from date of manufacture or as per label specifications
- Storage: Store below 25°C for Pre-Filled Syringes/Lyophilized (Do not freeze). Does not require cold-chain logistics. 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. COA, MSDS, Stability Data, Manufacturing Batch Record, Dossier Support (on request). Further certifications available on request
- Exports Ready Dossiers: COA, COPP, Dossier Available (CTD/eCTD formats). Complies with USP/EP/BP Standards
- 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?
- Government medical institutions with oncology and palliative care divisions
- Licensed pharmaceutical distributors and importers specializing in hormone therapy
- Clinical research organizations (CROs) with regulatory approvals
- Hospitals or healthcare systems managing hormone-sensitive cancers
- Ethical procurement bodies requiring specialty oncology or hormonal products in compliance with national controls
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 & all products
CONTACT DETAILS:
- E-MAIL: hello@pharmet.io
- Phone/WhatsApp Number: +91 9999091881
- Website: www.pharmet.io
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