Description

Ethinylestradiol & Levonorgestrel Film-Coated Tablets (0.03 mg / 0.15 mg)

Healthy Inc is a specialized global supplier and exporter of advanced women’s health, high-containment endocrinology, and family planning therapeutics. We provide ultra-high-purity, kinetically precise Ethinylestradiol & Levonorgestrel Tablets (30 mcg / 150 mcg), manufactured in WHO–GMP certified, strictly segregated high-containment (OEB 4) steroidal oral solid dosage facilities. This “Combined Oral Contraceptive (COC)” is a massive-volume, highly strategic export to gynecology centers, national family planning networks, massive NGO procurement boards (UNFPA), and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line intervention for reversible contraception and menstrual regulation.

Product Overview

This highly advanced formulation operates as a multi-tiered biochemical barrier. It artificially manipulates the female reproductive hormone cycle, tricking the brain into believing the body is already pregnant, thereby completely halting the release of new eggs while physically blocking sperm entry.

The “Hypothalamic-Pituitary-Ovarian Axis Suppressor” Specialist:

• Mechanism 1 (The Ovulation Blockade – Primary): The combination of a potent synthetic estrogen (Ethinylestradiol) and a highly active progestin (Levonorgestrel) exerts profound negative feedback on the hypothalamus and anterior pituitary gland. This violently suppresses the release of Gonadotropin-Releasing Hormone (GnRH), Luteinizing Hormone (LH), and Follicle-Stimulating Hormone (FSH). Without the mid-cycle LH surge, the ovaries remain dormant and physically cannot release an egg (inhibition of ovulation).
• Mechanism 2 (The Cervical Mucus Barrier – Secondary): Levonorgestrel acts directly on the cervix, forcing it to produce extremely thick, viscous, and scant cervical mucus. This creates an impenetrable physical and chemical barrier that massively retards sperm motility, preventing sperm from ever reaching the upper reproductive tract.
• Mechanism 3 (The Endometrial Atrophy – Tertiary): The hormones intentionally alter the cellular structure of the endometrium (the lining of the uterus). It becomes thin, atrophic, and biochemically hostile. Even in the highly unlikely event that an egg is released and fertilized, it physically cannot implant into the uterine wall.

Product Composition & Strength

We supply this product as a Precision-Blended, High-Density Microdose FDC Tablet, packed exclusively in highly secure, moisture-resistant “Calendar Blister” packs to ensure absolute daily patient compliance and chemical stability.

*Pack Sizes: 21-Day Active Blisters OR 28-Day Calendar Blisters (21 Active Hormonal Tablets + 7 Placebo/Iron Tablets to enforce daily habit-forming compliance).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• OEB 4/5 High-Containment & Microgram Uniformity (CRITICAL COMPLIANCE): Ethinylestradiol and Levonorgestrel are highly potent steroidal hormones. Manufacturing this FDC in standard generic facilities is strictly prohibited due to the severe risk of endocrine disruption and feminization in factory workers. Our production takes place in dedicated, negative-pressure High-Containment Isolator blocks (OEB 4/5) equipped with terminal HEPA filtration. Furthermore, blending a 0.03 mg active ingredient requires the absolute pinnacle of pharmaceutical dry-blending and HPLC analytical testing to guarantee 100% Content Uniformity, ensuring absolute contraceptive efficacy.

Therapeutic Indications (Human Use)

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

• Oral Contraception: The highly reliable prevention of pregnancy in women of reproductive age.
• Menstrual Disorders: Management of severe dysmenorrhea (painful cramps), menorrhagia (heavy bleeding), and irregular menstrual cycles.
• Polycystic Ovary Syndrome (PCOS): Off-label, first-line management of hyperandrogenism (acne, hirsutism) and cycle regulation in women with PCOS.

Dosage & Administration

Recommended Dosage (Strictly as per Gynecologist Guidelines):

• The Daily Protocol: One tablet must be taken daily at the exact same time each day.
• 21-Day Regimen: 1 tablet daily for 21 days, followed by a 7-day pill-free interval (during which a withdrawal bleed occurs), before starting a new pack.
• The “Missed Pill” Mandate: If a pill is missed by more than 12 hours, contraceptive efficacy drops dramatically. The patient must take the missed pill immediately and use a backup barrier method (condoms) for the next 7 days.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Cigarette Smoking & Cardiovascular Events): Cigarette smoking massively increases the risk of serious cardiovascular events (stroke, myocardial infarction) from combination oral contraceptives. This drug is absolutely contraindicated in women over 35 years old who smoke.
• Venous Thromboembolism (FATAL WARNING): COCs significantly increase the risk of developing Deep Vein Thrombosis (DVT) and fatal Pulmonary Embolism (PE). It is strictly contraindicated in women with a history of blood clots, severe hypertension, or prolonged immobilization.
• Migraine with Aura (Stroke Risk): Completely contraindicated in women who experience migraines accompanied by an aura, due to a highly magnified risk of ischemic stroke.
• CYP3A4 Enzyme Interactions (Contraceptive Failure): Co-administration with liver enzyme inducers (like Rifampin, Phenytoin, Carbamazepine, or St. John’s Wort) violently accelerates the breakdown of the hormones in the liver, leading to massive contraceptive failure and unplanned pregnancy.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and NGO Family Planning Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Contraceptives, Hormonal FDCs, and OEB 4 High-Containment Formulations. Whether you are looking for a reliable Government Tender Supplier for national family planning programs in Africa (UNFPA) or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.