Description

Clomifene Citrate Film-Coated Tablets (50 mg / 100 mg)

Healthy Inc is a specialized global supplier and exporter of advanced women’s health, reproductive endocrinology, and targeted fertility therapeutics. We provide ultra-high-purity, kinetically precise Clomifene Citrate Film-Coated Tablets (50 mg / 100 mg), manufactured in WHO–GMP certified, light-protected and strictly contained oral solid dosage facilities. This “Selective Estrogen Receptor Modulator (SERM)” is a massive-volume, highly strategic export to IVF centers, gynecology networks, fertility clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, first-line medical intervention for the successful induction of ovulation in women suffering from PCOS and anovulatory infertility.

Product Overview

This highly advanced formulation operates as a sophisticated, biochemical “decoy” for the female reproductive brain. Instead of directly stimulating the ovaries, it temporarily blocks the brain’s ability to detect estrogen, triggering a massive, natural hormonal cascade that forces the ovaries to wake up and release a mature egg.

The “HPA Axis Modulator & Ovulation Catalyst” Specialist:

• Mechanism 1 (The Hypothalamic Estrogen Blockade): Normally, circulating estrogen creates a “negative feedback loop,” telling the hypothalamus to stop producing reproductive hormones. Clomifene acts as a competitive antagonist, violently binding to and blocking estrogen receptors in the hypothalamus. The brain is tricked into believing the body is in a state of severe estrogen starvation.
• Mechanism 2 (The GnRH, FSH & LH Surge): Panicking over the “low” estrogen levels, the hypothalamus rapidly increases the pulsatile secretion of Gonadotropin-Releasing Hormone (GnRH). This commands the anterior pituitary gland to release massive surges of Follicle-Stimulating Hormone (FSH) and Luteinizing Hormone (LH) directly into the bloodstream.
• Mechanism 3 (Follicular Maturation & Rupture): The surging FSH travels to the ovaries, violently stimulating the growth and maturation of the dormant ovarian follicles. Following a 5-day course of the drug, the sudden spike in LH triggers the physical rupture of the dominant follicle, successfully releasing a mature egg (ovulation) ready for fertilization.

Product Composition & Strength

We supply this product as a Precision-Blended, Light-Shielded Fertility Tablet, packed exclusively in highly secure, opaque Alu-PVC or heavy-gauge Alu-Alu blister strips to ensure the absolute chemical stability of the photosensitive SERM.

*Pack Sizes: 10-Tablet or 5-Tablet Blisters (Optimized specifically for the strict, 5-day cyclical dosing regimen utilized in reproductive endocrinology).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Hormonal Containment & Isomeric Profiling (CRITICAL COMPLIANCE): Clomifene is a highly potent endocrine disruptor containing a mixture of two geometric isomers (Enclomifene and Zuclomifene). If generic manufacturers fail to maintain the strict USP/Ph.Eur. ratio of these isomers, the drug will fail to induce ovulation. Our reproductive suites operate under strict OEB containment to protect workers from hormonal exposure, and utilize advanced HPLC profiling to guarantee the perfect isomeric ratio, ensuring absolute clinical bioequivalence to the originator brand.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of reproductive dysfunction:

• Anovulatory Infertility (Females): First-line treatment for the induction of ovulation in patients with persistent anovulatory dysfunction (including PCOS) who desire pregnancy and whose partners are fertile.
• Male Hypogonadism (Off-Label): Utilized selectively by urologists to stimulate endogenous testosterone production and spermatogenesis in men with secondary hypogonadism or oligospermia.

Dosage & Administration

Recommended Dosage (Strictly as per Reproductive Endocrinologist Guidelines):

• The 5-Day Protocol: 50 mg daily for 5 consecutive days, usually starting on the 2nd, 3rd, 4th, or 5th day of the menstrual cycle following spontaneous or progestin-induced bleeding.
• Dose Escalation: If ovulation does not occur, the dose may be increased to 100 mg daily for 5 days in the subsequent cycle. Doses exceeding 100 mg/day are rarely effective and heavily increase the risk of toxic side effects.
• Therapeutic Limit: Therapy is generally not recommended beyond 6 total cycles due to diminishing returns and a potential epidemiological risk of borderline ovarian tumors with prolonged, continuous use.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Ovarian Hyperstimulation Syndrome (OHSS) [FATAL WARNING]: Clomifene can trigger severe OHSS, a life-threatening condition where the ovaries violently swell and leak massive amounts of fluid into the abdomen and chest cavity, causing renal failure and respiratory distress. Pelvic ultrasounds must be utilized to monitor follicular growth.
• Multiple Gestation (Twins/Triplets): Patients must be explicitly counseled that Clomifene dramatically increases the chance of releasing multiple eggs, resulting in an 8% to 10% risk of multiple pregnancies, carrying severe obstetric risks.
• Visual Disturbances (Contraindication): Can cause blurring, spots, or flashes of light (scotoma). If a patient experiences visual symptoms, therapy must be halted permanently, and a complete ophthalmological evaluation performed, as this can lead to permanent vision damage.
• Hepatic Impairment: Strictly contraindicated in patients with liver disease or a history of liver dysfunction.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and IVF/Fertility Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Reproductive Therapeutics, SERMs, and Light-Shielded Hormonal Formulations. Whether you are looking for a reliable Government Tender Supplier for maternal health programs in Africa or a B2B Pharma Marketplace partner for the CIS, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.