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Description
PRODUCT DESCRIPTION:
Micronized Progesterone Injection is a bio-identical progestin that closely mimics natural human progesterone.
It plays a crucial role in supporting the luteal phase, regulating menstrual cycles, and maintaining pregnancy, especially in assisted reproductive techniques (ART) and high-risk pregnancies.
Available in 50 MCG, 100 MCG, and 200 MCG strengths, this sterile, oil-based intramuscular formulation provides enhanced bioavailability and clinical efficacy, ensuring effective hormonal support where oral or vaginal routes are less optimal.
Produced under GMP-compliant conditions, the product is tailored to meet the precision dosing needs of fertility and gynecology programs.
Formulation & Presentation:
- Dosage Form: Injectable Solution
- Presentation: Sterile, single-use ampoule or vial (customizable as per market demand)
- Available Strengths: 50 MCG, 100 MCG, 200 MCG
- Route of Administration: Intramuscular Only (IM) or as per clinical indication and severity (As per physician’s discretion or decision)
Therapeutic Indications:
- Luteal phase support in assisted reproductive technologies (ART/IVF)
- Hormone replacement therapy (HRT) in peri- and postmenopausal women
- Treatment of secondary amenorrhea or menstrual irregularities due to progesterone deficiency
- Prevention of preterm birth and miscarriage in selected high-risk pregnancies
- Adjunct in estrogen therapy to prevent endometrial hyperplasia
Side Effects:
- COMMON:
- Injection site discomfort
- Breast tenderness
- Mood changes
- Mild bloating
- SERIOUS (RARE):
- Allergic reactions (rash, swelling, anaphylaxis)
- Thromboembolic events (extremely rare)
- Depression or breakthrough bleeding
- Cholestatic jaundice (in prolonged use)
- PRECAUTIONS:
- Not recommended in patients with a history of thromboembolic disorders, liver dysfunction, or hormone-sensitive malignancies
- Monitor patients with cardiovascular or renal conditions
- Use under specialist supervision, especially in fertility or pregnancy-related therapy
- Periodic liver function tests advised for long-term use
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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): 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?
- Micronized Progesterone Injection is ideal for fertility clinics, IVF centers, gynecology departments, women’s health NGOs, and government programs focusing on reproductive health.
- It is particularly relevant in Africa, Southeast Asia, Latin America, and Middle Eastern markets where demand for injectable hormonal support in reproductive medicine continues to grow.
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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