Description

Dydrogesterone Film-Coated Tablets (10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced women’s health, reproductive endocrinology, and targeted high-containment fertility therapeutics. We provide ultra-high-purity, kinetically stabilized Dydrogesterone Film-Coated Tablets (10 mg), manufactured in WHO–GMP certified, strictly segregated maximum-containment (OEB 4/5) steroidal oral solid dosage facilities. This “Highly Selective Retroprogesterone” is a massive-volume, high-value export to IVF (In Vitro Fertilization) centers, specialized maternity networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, non-sedating intervention for Luteal Phase Defect, threatened miscarriage, and severe endometriosis.

Product Overview

This highly advanced formulation operates as a highly specific, pro-gestational molecular switch. Unlike older synthetic progestins which carry dangerous off-target hormonal effects, Dydrogesterone is engineered to do exactly one thing: create a structurally and biochemically perfect environment for a fertilized embryo to implant and survive.

The “Retroprogesterone & Luteal Support” Specialist:

• Mechanism 1 (The Stereoisomer Advantage): Dydrogesterone is a stereoisomer of natural progesterone (a “retroprogesterone”). Because of a unique double bond and a different spatial arrangement (9-beta, 10-alpha), it is highly stable in the human gut and survives liver first-pass metabolism far better than natural progesterone, granting it exceptional oral bioavailability.
• Mechanism 2 (Absolute Receptor Selectivity): Standard synthetic progestins frequently cross-react with androgenic (male hormone) or estrogenic receptors, which can cause devastating virilization (masculinization) of a female fetus. Dydrogesterone has absolutely zero androgenic, estrogenic, anabolic, or corticoid activity. It binds exclusively to the progesterone receptor, ensuring 100% fetal safety.
• Mechanism 3 (The Non-Ovulatory Paradox): A massive clinical advantage in fertility medicine is that Dydrogesterone, at standard therapeutic doses, does not inhibit ovulation. This allows gynecologists to prescribe it to regulate severely disrupted menstrual cycles or treat endometriosis while still allowing the patient to conceive naturally.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the retro-steroidal API.

*Pack Sizes: 10×10 Blisters or Calendar Blisters of 14/28 (Optimized specifically for precise tracking during the menstrual cycle and IVF protocols).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• OEB 4/5 Steroidal Containment (CRITICAL COMPLIANCE): Dydrogesterone is a potent synthetic hormone. If standard generic facilities attempt to press this drug, airborne steroidal dust can cause severe endocrine disruption and menstrual irregularities in female factory workers. Our production takes place in dedicated, negative-pressure High-Containment Suites (OEB 4/5) utilizing closed-loop material transfer and terminal HEPA filtration. We guarantee absolute worker safety, zero cross-contamination, and strict pharmacokinetic bioequivalence for fertility clinics.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of progesterone-deficiency conditions:

• Infertility & IVF Support: Luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for infertile women.
• Threatened & Habitual Abortion: Emergency and prophylactic prevention of miscarriage caused by proven or suspected endogenous progesterone deficiency.
• Endometriosis & Dysmenorrhea: Suppression of endometrial tissue overgrowth outside the uterus, and relief of severe, debilitating menstrual cramps.
• Hormone Replacement Therapy (HRT): Used cyclically alongside estrogens to protect the endometrium from hyperplasia in postmenopausal women with an intact uterus.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecologist / IVF Protocol):

• Threatened Abortion: An initial massive “stat” dose of 40 mg, followed by 10 mg every 8 hours until symptoms remit.
• Habitual Abortion / IVF Support: Typically 10 mg twice daily starting from the luteal phase and continuing until the 12th to 20th week of pregnancy.
• Administration: Tablets can be taken with or without food. They should be swallowed whole with water.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Hepatic Impairment: Therapy must be discontinued immediately if severe liver dysfunction (e.g., severe acute hepatic disease) occurs during treatment, as the drug relies heavily on the liver for clearance.
• Undiagnosed Vaginal Bleeding: Strictly contraindicated in patients suffering from abnormal, undiagnosed vaginal bleeding, as it can mask an underlying malignancy (e.g., endometrial cancer).
• The “Non-Sedating” Advantage: Unlike natural micronized progesterone, Dydrogesterone does not undergo conversion into neurosteroid metabolites (like allopregnanolone) in the brain. Therefore, it does not cause the profound drowsiness, dizziness, or intoxication effect commonly associated with massive doses of natural progesterone.
• HRT Co-Administration Risks: When prescribed alongside an estrogen for postmenopausal HRT, the patient must be counseled on the increased risks of Venous Thromboembolism (VTE) and breast cancer associated with combined hormonal therapies.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Gynecology/Fertility Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Synthetic Progestins, Luteal Phase Therapeutics, and OEB 4/5 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for maternal health programs in Africa or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.