Pregnyl

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Pregnyl injection contains the active ingredient human chorionic gonadotropin (hCG), which is derived from the urine of pregnant women. It is supplied as a freeze-dried powder in one vial and a separate solvent in a second vial, which are mixed just before injection.

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Description

Human Chorionic Gonadotropin (hCG) for Injection

Healthy Inc is a specialized global supplier and exporter of advanced endocrinology and reproductive therapies. We provide high-purity Human Chorionic Gonadotropin (hCG) Injection (5000 IU / 10000 IU), manufactured in WHO–GMP certified sterile biological facilities. This “Luteinizing Hormone Analog” is a mandatory export to IVF centers, fertility clinics, endocrinology departments, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a critical intervention for ovulation induction in females and the stimulation of testosterone production in males.


Product Overview

This formulation contains Highly Purified Human Chorionic Gonadotropin (hCG), a complex glycoprotein hormone typically obtained from the urine of pregnant women (or via recombinant technology).

The “Gonadal Stimulator” Specialist:

  • Mechanism (LH Mimicry): The biological action of hCG is almost identical to that of pituitary Luteinizing Hormone (LH). It binds to the LH/CG receptor on the target gonadal cells.
  • Female Fertility (The Ovulation Trigger): In women undergoing assisted reproductive technology (ART) or ovulation induction, follicle-stimulating hormone (FSH) is used to grow the ovarian follicles. Once mature, a precise injection of hCG acts as the artificial “LH Surge,” triggering the final maturation and release of the egg (ovulation) exactly 36 to 40 hours later. It also supports the corpus luteum, ensuring progesterone production to maintain early pregnancy.
  • Male Hypogonadism (Leydig Cell Activation): In males with hypogonadotropic hypogonadism, hCG directly stimulates the Leydig cells in the testes to produce endogenous testosterone, reversing testicular atrophy and promoting spermatogenesis.

Product Composition & Strength

We supply this product as a Sterile Lyophilized Powder (White Plug/Cake) in glass vials, accompanied by a specific sterile diluent.

Active IngredientStrength (International Units)Reconstitution Requirement
Highly Purified hCG USP/BP5,000 IURequires 1 ml of 0.9% Sodium Chloride
Highly Purified hCG USP/BP10,000 IURequires 1 ml of 0.9% Sodium Chloride
ExcipientsMannitol / Monobasic Sodium PhosphateBulking Agent / pH Buffer

*Pack Sizes: 1 Vial of Lyophilized Powder + 1 Ampoule of Diluent (1 ml) per box.


Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and Fertility Clinics.

HS Code3004.39.00 (Medicaments containing hormones, but not containing antibiotics)
CAS Number9002-61-3
Dosage FormLyophilized Powder for Injection
PackagingType I Glass Vial (Powder) + Type I Glass Ampoule (Solvent).
Storage (Strict Cold Chain)Store refrigerated at 2°C to 8°C. Protect from Light. Reconstituted solution must be used immediately; discard any unused portion.
CertificatesWHO-GMP, COPP, Free Sale Certificate, Viral Clearance Certification

Manufacturing Authority

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

  • Viral Inactivation & Purification: Because conventional hCG is extracted from biological sources, our manufacturing process utilizes rigorous, multi-step chromatographic purification and validated viral inactivation protocols (such as solvent/detergent treatment or nanofiltration) to guarantee absolute freedom from blood-borne pathogens and pyrogens.
  • Precise Lyophilization: The freeze-drying cycle is meticulously controlled to ensure a highly porous, stable cake that dissolves instantly upon the introduction of the saline diluent, ensuring precise IU dosing without clumping.

Therapeutic Indications (Human Use)

Indicated for targeted endocrine and reproductive treatments:

  • Female Infertility: Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure.
  • Assisted Reproductive Technology (ART): Used to trigger final follicular maturation and luteinization after stimulation of follicular growth (e.g., IVF protocols).
  • Male Hypogonadotropic Hypogonadism: Selected cases of hypogonadotropic hypogonadism (stimulating testosterone production).
  • Prepubertal Cryptorchidism: Not due to anatomical obstruction.

Dosage & Administration

Recommended Dosage (Strictly as per Reproductive Endocrinologist):

  • Route: Intramuscular (IM) or Subcutaneous (SC) Injection.
  • Ovulation Induction (Females): 5,000 to 10,000 IU given one day following the last dose of menotropins (FSH). Timing is absolutely critical; injection must be given exactly as scheduled to coordinate with intercourse or intrauterine insemination (IUI).
  • Hypogonadism (Males): 500 to 1,000 IU three times a week, or 4,000 IU three times a week for 6 to 9 months, depending on response.
  • Cryptorchidism (Boys): Typically 1,000 to 2,000 IU on alternate days for a specific regimen.

Safety Warnings (CRITICAL):

  • Ovarian Hyperstimulation Syndrome (OHSS): FATAL RISK. In females, excessive stimulation of the ovaries can lead to OHSS—a sudden, severe enlargement of the ovaries accompanied by massive fluid shifts (ascites, pleural effusion, shock). Treatment must be monitored via transvaginal ultrasound and serum estradiol levels. Withhold hCG if ovaries are excessively enlarged.
  • Multiple Pregnancies: Use of hCG significantly increases the risk of multiple gestations (twins, triplets), which carry higher obstetric risks.
  • Male Contraindications: Strictly contraindicated in men with prostate carcinoma, breast carcinoma, or other androgen-dependent neoplasms, as hCG stimulates testosterone production.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Fertility Clinics, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Hormonal and Fertility Injectables, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Government Tender Supplier for reproductive health programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures secure cold-chain delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.Pregnyl

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