Mifepristone Tablets (200 mg)

Healthy Inc is a specialized global supplier and exporter of advanced women’s health, endocrinology, and reproductive therapeutics. We provide ultra-high-purity, kinetically stabilized Mifepristone Uncoated / Film-Coated Tablets (200 mg), manufactured in WHO–GMP certified, highly regulated and strictly audited oral solid dosage facilities. This “Selective Progesterone Receptor Antagonist” is a massive-volume, highly critical export to obstetrics and gynecology centers, international family planning NGOs, reproductive health networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for the medical termination of intrauterine pregnancy and the management of early miscarriage.


Product Overview

This highly advanced formulation fundamentally alters the hormonal environment of the uterus. By aggressively blocking the hormone that sustains a pregnancy, it initiates a highly predictable, medically managed reproductive cascade that eliminates the severe risks associated with invasive surgical procedures.

The “Progesterone Blockade & Decidual Necrosis” Specialist:

  • Mechanism 1 (The Progesterone Receptor Antagonism): Progesterone is the absolute biological requirement for maintaining the uterine lining (the decidua) and sustaining an early pregnancy. Mifepristone possesses a binding affinity for the progesterone receptor that is up to five times higher than natural progesterone itself. It violently binds to and blocks these receptors, causing immediate decidual necrosis (breakdown of the uterine lining) and detachment of the embryo.
  • Mechanism 2 (Cervical Softening & Myometrial Sensitization): Simultaneously, Mifepristone actively alters the physical structure of the cervix, causing it to dilate and soften. Furthermore, it completely removes the “quieting” effect of progesterone on the uterine muscle (the myometrium), massively increasing the uterus’s sensitivity to endogenous and exogenous prostaglandins.
  • The “MTP Protocol” Synergy: Mifepristone is the primer; it does not reliably expel the pregnancy on its own. It is designed to be followed 24 to 48 hours later by a synthetic prostaglandin analogue (like Misoprostol), which triggers the actual uterine contractions. This sequential, two-drug protocol boasts a clinical success rate of over 95% for early medical abortion, completely revolutionizing global reproductive health.
  • Mechanism 3 (Glucocorticoid Blockade): At much higher doses, Mifepristone also powerfully blocks glucocorticoid receptors. While secondary in gynecology, this makes it a life-saving, FDA-approved therapy for controlling extreme high blood sugar in patients with severe Cushing’s Syndrome.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, NGO Procurement Boards, and Health Ministries.

HS Code3004.39.00 (Medicaments containing hormones or other products of heading 29.37 – Reproductive/Gynecological)
CAS Number84371-65-3 (Mifepristone)
Dosage FormUncoated or Film-Coated Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates, ensuring absolute potency for remote NGO field distribution.
StorageStore strictly below 25°C in a dry place. Protect heavily from Light and Moisture.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

  • High-Precision Synthesis & Regulatory Compliance (CRITICAL COMPLIANCE): Due to its profound medical function, Mifepristone is subject to intense regulatory scrutiny. A failed batch resulting in an incomplete termination poses catastrophic sepsis risks to the patient. Our facilities utilize strictly audited, high-shear wet granulation and elite API sourcing. Every single tablet undergoes rigorous content uniformity and dissolution testing, ensuring that Healthy Inc delivers a flawless, 100% reliable clinical response that international family planning organizations can trust implicitly.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of reproductive health and endocrinology:

  • Medical Termination of Pregnancy (MTP): Indicated, in a sequential regimen with a prostaglandin analogue (like Misoprostol), for the medical termination of intrauterine pregnancy through 70 days gestation.
  • Management of Miscarriage: Medical management of early pregnancy loss (missed abortion) to facilitate complete expulsion without surgery.
  • Cushing’s Syndrome (Endocrinology): Control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who are not candidates for surgery.
  • Uterine Fibroids: Off-label use in specific low-dose regimens to shrink severe uterine leiomyomas.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecologist/WHO Guidelines):

  • Standard MTP Dosing: 200 mg taken orally as a single dose.
  • The Sequential Requirement: 24 to 48 hours after ingesting Mifepristone, the patient MUST be administered a synthetic prostaglandin (typically Misoprostol 800 mcg buccally, sublingually, or vaginally) to induce the contractions that expel the pregnancy.
  • Administration: Swallowed whole with water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • BLACK BOX WARNING (Serious and Sometimes Fatal Infections): Cases of severe, fatal toxic shock syndrome and sepsis (frequently caused by Clostridium sordellii) have occurred following the use of Mifepristone/Misoprostol. Patients must be heavily counseled to immediately report high fever, severe abdominal pain, or heavy bleeding.
  • BLACK BOX WARNING (Severe Bleeding): Prolonged, heavy vaginal bleeding is an expected part of the mechanism, but in rare cases, it can become dangerously severe, requiring surgical intervention (D&C) or blood transfusions.
  • Ectopic Pregnancy (Absolute Contraindication): Mifepristone is 100% ineffective in treating an ectopic (tubal) pregnancy. Administration in this scenario will mask the symptoms of a rupturing fallopian tube, leading to fatal internal hemorrhage. An intrauterine pregnancy must be confirmed prior to dosing.
  • Chronic Adrenal Failure: Contraindicated in patients with severe, chronic adrenal failure or those on long-term concurrent corticosteroid therapy.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gynecological, Endocrine, and Reproductive Formulations. Whether you are looking for a reliable Government Tender Supplier for family planning initiatives in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.

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