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Description
PRODUCT DESCRIPTION:
Mifepristone Tablets 200 MG is a potent anti-progestin agent primarily used in combination with a prostaglandin analog for medical termination of intrauterine pregnancy up to 63 days of gestation.
It works by blocking the action of progesterone, a hormone essential for pregnancy continuation.
Manufactured under stringent quality standards, this formulation ensures efficacy, safety, and regulatory compliance for international markets.
Formulation & Presentation:
- Dosage Form: Tablets
- Presentation: Available in Blister Pack or HDPE Bottle (As per market requirement)
- Available Strengths:
- Mifepristone 200 MG Tablets
- Route of Administration: Oral (As per physician’s discretion or therapeutic indication)
Therapeutic Indications:
- Medical termination of early intrauterine pregnancy
- Cervical ripening prior to surgical abortion
- Management of hyperglycemia in Cushing’s syndrome (investigational/off-label in some markets)
- Emergency contraception (as per local regulatory approval)
Side Effects:
- COMMON: Nausea, Vomiting, Abdominal cramping, Vaginal bleeding
- SERIOUS (RARE): Incomplete abortion requiring surgical intervention, Severe uterine bleeding, Infection or sepsis, Hypersensitivity reactions
- PRECAUTIONS:
- Must be used under medical supervision with access to emergency care
- Contraindicated in ectopic pregnancy, chronic adrenal failure, and in patients on long-term corticosteroid therapy
- Should not be used if the patient is allergic to Mifepristone or any excipients
- Pregnancy must be confirmed and gestational age assessed before administration
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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?
- Government health agencies and reproductive health programs
- Pharmaceutical distributors focusing on women’s health
- NGOs and public health organizations offering safe reproductive care
- Hospitals and clinics providing medical abortion services
- Ethical procurement teams sourcing WHO/GMP-certified hormonal agents
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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