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Description
PRODUCT DESCRIPTION:
Estradiol Valerate Injection is a long-acting estrogen ester used in the treatment of various hormonal and reproductive disorders.
It provides sustained estrogenic activity, mimicking natural estradiol, and is widely utilized in hormone replacement therapy (HRT), management of menopausal symptoms, female hypogonadism, and as part of assisted reproductive technologies (ART).
Formulated as a ready-to-use Pre-Filled Syringe, it ensures precision dosing, sterility, and ease of use in clinical and outpatient settings.
Formulation & Presentation:
- Dosage Form: Sterile Injectable (Sterile Lyophilized Solution for Reconstitution)
- Presentation: Pre-Filled Syringe (customizable as per market demand)
- Available Strengths:
- 10 MG/ ML (Pre-Filled Syringe)
- Route of Administration: Intramuscular (IM)/ To be used only 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:
- Hormone Replacement Therapy (HRT) in menopausal and postmenopausal women
- Management of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure
- Delayed puberty in females
- Menstrual irregularities (e.g., amenorrhea)
- As part of feminizing hormone therapy for transgender women
- Supportive therapy in Assisted Reproductive Technologies (ART/IVF)
Side Effects:
- COMMON:
- Injection site pain or swelling
- Nausea, breast tenderness
- Headache, mood changes
- Fluid retention
- SERIOUS (RARE):
- Thromboembolic events (DVT, pulmonary embolism)
- Gallbladder disease
- Hypertension
- Risk of endometrial hyperplasia with unopposed estrogen
- Liver function impairment in prolonged use
- PRECAUTIONS:
- Use cautiously in patients with a history of cardiovascular disease, liver disorders, or thromboembolic events
- Periodic monitoring advised for blood pressure, liver enzymes, and lipid profile
- Not recommended in undiagnosed vaginal bleeding or estrogen-dependent tumors
- Evaluate risks and benefits in long-term use for HRT
- Consider adding progestin in women with an intact uterus to minimize endometrial risks
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TECHNICAL INFORMATION
Product Specifications:
- HSN Code: To be assigned per international classification standards & import jurisdiction
- Weight: Approx. 40 GM 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 between 2°C to 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?
- Gynecology and endocrinology clinics offering hormone replacement therapy
- Fertility centers and IVF clinics requiring estradiol support for ART cycles
- Transgender healthcare providers involved in hormone therapy protocols
- Hospitals and medical missions in need of stable, ready-to-use hormonal injectables
- Distributors in LATAM, Africa, and South Asia supplying women’s health & reproductive care products
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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