Medroxyprogesterone Acetate Tablets

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Product Composition & Strength

We supply this product as a Precision-Blended, Micronized Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the delicate steroid molecule.

Active IngredientStrengthPrimary Clinical Function
Medroxyprogesterone Acetate USP/Ph.Eur.2.5 mg / 5 mgHRT Maintenance Standard: Continuous or sequential low-dose therapy for the prevention of endometrial hyperplasia in postmenopausal women receiving estrogen.
Medroxyprogesterone Acetate USP/Ph.Eur.10 mgAcute Gynecology Standard: High-efficacy adult dosing for the rapid arrest of abnormal uterine bleeding and the induction of withdrawal bleeding in secondary amenorrhea.
ExcipientsLactose Monohydrate / Microcrystalline Cellulose / Crospovidone / Magnesium StearateDiluent / Binder / Superdisintegrant / Lubricant (Engineered specifically utilizing advanced micronized API to overcome the severe hydrophobicity of the steroid, ensuring maximum, predictable gastric absorption)

*Pack Sizes: 10×10 Blisters or 14-Day Calendar Packs (Optimized specifically for strict cyclic or continuous gynecological dispensing regimens).

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Description

Medroxyprogesterone Acetate Tablets (2.5 mg / 5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced women’s health, endocrinology, and hormone replacement therapeutics. We provide ultra-high-purity, kinetically optimized Medroxyprogesterone Acetate Tablets (2.5 mg / 5 mg / 10 mg), manufactured in WHO–GMP certified, strictly segregated hormonal oral solid dosage facilities. This “Synthetic Progestin & Endometrial Stabilizer” is a massive-volume, highly lucrative export to gynecology centers, menopause and HRT clinics, family planning networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for secondary amenorrhea, abnormal uterine bleeding, and the prevention of endometrial hyperplasia.


Product Overview

This highly advanced formulation perfectly mimics the physiological effects of natural progesterone but with significantly enhanced oral potency. It acts as the “master regulator” of the uterine lining, forcefully halting chaotic bleeding and shielding the uterus from the dangerous overstimulation of unopposed estrogen.

The “Endometrial Transformer & Hemostatic” Specialist:

  • Mechanism 1 (The Endometrial Shift): In cases of abnormal uterine bleeding, the endometrium (uterine lining) is often locked in a continuous, unstable growth phase driven by estrogen. Medroxyprogesterone Acetate violently interrupts this cycle. It transforms the proliferative endometrium into a stable, secretory endometrium. When the drug is withdrawn after a 10-day cycle, it triggers a clean, predictable, and controlled “withdrawal bleed,” essentially resetting the patient’s menstrual cycle.
  • Mechanism 2 (Gonadotropin Suppression): At higher or continuous doses, MPA acts on the pituitary gland to suppress the secretion of gonadotropins (FSH and LH). By shutting down the hormonal signals that trigger follicular maturation and ovulation, it rests the ovaries and provides relief in conditions driven by hormonal cycling, such as mild endometriosis.
  • Mechanism 3 (The Endometrial Hyperplasia Shield): Postmenopausal women taking estrogen replacement therapy (HRT) to survive severe hot flashes and bone loss face a massive risk of developing endometrial cancer if the estrogen is “unopposed.” MPA is the globally mandated co-prescription. It actively thins the uterine lining and prevents the cellular hyperplasia (overgrowth) that precedes uterine malignancies.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gynecology Distributors, and Hospital Procurement Boards.

HS Code3004.39.00 (Medicaments containing hormones or other products of heading 29.37 – Gynecology)
CAS Number71-58-9 (Medroxyprogesterone Acetate)
Dosage FormUncoated / Scored Tablet (Immediate Gastric Release)
PackagingHigh-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates.
StorageStore strictly below 25°C in a dry place. Protect from Light and Moisture.

Manufacturing Authority

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

  • Hormonal Segregation & Micronization Engineering (CRITICAL COMPLIANCE): Manufacturing oral steroids is highly regulated. To prevent the catastrophic cross-contamination of general medicines with potent female hormones, MPA is manufactured in completely segregated, dedicated hormonal suites with independent HVAC and HEPA filtration. Furthermore, raw MPA cannot dissolve in the stomach. Our facilities utilize advanced air-jet milling to “micronize” the API to a highly specific particle size, maximizing the surface area and guaranteeing rapid, flawless absorption into the patient’s bloodstream.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of the female endocrine system:

  • Secondary Amenorrhea: Restoration of menstrual bleeding in women who have stopped menstruating due to hormonal imbalances.
  • Abnormal Uterine Bleeding: Arresting severe, irregular bleeding caused by hormonal dysfunction in the absence of organic pathology (like fibroids or cancer).
  • Endometrial Hyperplasia Prophylaxis: Co-administered with conjugated estrogens in postmenopausal women with an intact uterus to prevent endometrial cancer.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecologist Guidelines):

  • Secondary Amenorrhea / Abnormal Bleeding: 5 mg to 10 mg daily for 5 to 10 days. A predictable withdrawal bleed typically occurs 3 to 7 days after stopping the therapy.
  • HRT Protection: Typically 2.5 mg or 5 mg daily on a continuous basis, or 5 mg to 10 mg daily for 12 to 14 days per 28-day cycle, alongside estrogen.
  • Administration: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

  • BLACK BOX WARNING (Cardiovascular Disorders & Dementia): Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Therapy massive increases the risks of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), stroke, and myocardial infarction.
  • BLACK BOX WARNING (Breast Cancer Risk): The Women’s Health Initiative (WHI) study demonstrated an increased risk of invasive breast cancer in postmenopausal women taking combined estrogen and MPA. Therapy must be prescribed at the lowest effective dose for the shortest duration possible.
  • Pregnancy (Absolute Contraindication): Strictly contraindicated in pregnancy. Can cause severe fetal abnormalities. It must not be used as a “pregnancy test” to induce bleeding.
  • Hepatic Impairment: Contraindicated in patients with active liver disease or severe hepatic dysfunction.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gynecology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Hormonal, Micronized, and Gynecological Formulations. Whether you are looking for a reliable Government Tender Supplier for family planning clinics in the CIS 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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