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Chorionic gonadotropin API Manufacturers & Suppliers

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Chorionic Gonadotropin (Human) | CAS No: 9002-61-3 | GMP-certified suppliers

A medication that supports treatment of cryptorchidism and male hypogonadotropic hypogonadism while aiding ovulation induction in appropriately prepared anovulatory women for reproductive management needs.

Therapeutic categories

Amino Acids, Peptides, and ProteinsBiological ProductsChorionic GonadotropinComplex MixturesFertility AgentsFertility Agents, Female
Generic name
Chorionic Gonadotropin (Human)
Molecule type
biotech
CAS number
9002-61-3
DrugBank ID
DB09126
Approval status
Approved drug, Vet_approved drug
ATC code
G03GA01

Primary indications

  • For the treatment of prepubertal cryptorchidism (not due to anatomical obstruction), for the treatment of selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males and for the 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, and who has been appropriately pretreated with human menotropins

Product Snapshot

  • Injectable peptide hormone supplied mainly as liquid and lyophilized powders for intramuscular or subcutaneous administration
  • Used in male cryptorchidism and hypogonadotropic hypogonadism, and for ovulation induction in anovulatory infertility
  • Approved for human use in the US and Canada, with additional veterinary approvals

Clinical Overview

Chorionic gonadotropin (human) is a placental peptide hormone used therapeutically for conditions requiring luteinizing hormone activity. Clinically, it is indicated for prepubertal cryptorchidism without anatomical obstruction, selected cases of male hypogonadotropic hypogonadism related to pituitary deficiency, and for ovulation induction in anovulatory women who have been appropriately primed with human menotropins. In these settings, it acts as an exogenous LH stimulus to support steroidogenesis and reproductive function.

Pharmacologically, the hormone binds and activates the LHCG receptor on ovarian theca and luteal cells and on testicular Leydig cells. This receptor activation promotes progesterone secretion by the corpus luteum in females and androgen production in males. The pharmacodynamic profile is closely aligned with pituitary LH, with minimal FSH-like activity.

As a large glycoprotein composed of alpha and beta subunits, chorionic gonadotropin follows the disposition profile typical of peptide hormones. It is administered parenterally due to negligible oral bioavailability. After injection, it distributes primarily within extracellular fluid and undergoes metabolic degradation by proteolytic pathways. Elimination occurs via renal and hepatic mechanisms, with an effective half-life generally reported in the range of one to two days depending on formulation and route.

Safety considerations include the risk of ovarian hyperstimulation when used for fertility treatment, fluid retention, and potential exacerbation of hormone-sensitive conditions. In males, gynecomastia can occur due to increased estrogen production. Use requires monitoring of endocrine response and avoidance in patients with hormone-dependent tumors or unrelated causes of testicular descent failure. Preparations are derived from the urine of pregnant individuals and are highly purified to minimize pyrogenicity and immunologic reactivity.

Commercially, the API is used in injectable products for reproductive endocrinology and in certain veterinary reproductive applications.

For API procurement, sourcing should prioritize validated purification processes, control of biological origin materials, and compliance with pharmacopeial specifications to ensure consistency, purity, and traceability of the hormone preparation.

Identification & chemistry

Generic name Chorionic Gonadotropin (Human)
Molecule type Biotech
CAS 9002-61-3
UNII 20ED16GHEB
DrugBank ID DB09126

Pharmacology

SummaryHuman chorionic gonadotropin acts as an agonist at the lutropin‑choriogonadotropic hormone receptor, mimicking luteinizing hormone with minor follicle‑stimulating activity. Activation of this receptor promotes gonadal steroidogenesis, including androgen production in Leydig cells and progesterone synthesis in the corpus luteum. These endocrine effects support its use in conditions involving deficient LH-dependent reproductive function.
PharmacodynamicsThe action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
Targets
TargetOrganismActions
Lutropin-choriogonadotropic hormone receptorHumansligand

Formulation & handling

  • Produced as a biotech peptide hormone requiring parenteral administration, typically supplied as lyophilized powder for IM or SC reconstitution.
  • Formulations require protection from heat and agitation, with reconstituted solutions having limited stability and needing controlled cold-chain handling.
  • Protein nature makes it susceptible to adsorption and degradation, so formulation commonly includes stabilizers and low‑interaction primary packaging.

Regulatory status

LifecycleThe API’s U.S. patent expired in 2021, indicating that the product is in a mature stage of its lifecycle with potential for generic competition. With availability in both the United States and Canada, the market is established and largely driven by post‑patent dynamics.
MarketsCanada, US
Supply Chain
Supply chain summaryChorionic Gonadotropin (Human) is supplied primarily by a small group of originator manufacturers, with branded injectable products established in the US and Canada. Market presence is concentrated in these regions, with limited evidence of broader global distribution. The listed US patent expired in 2021, indicating that generic or follow‑on competition is likely already present or emerging.

Certificate of Analysis

A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
 

Chorionic gonadotropin is a type of Gonadotrophic


Gonadotrophic is a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that plays a crucial role in reproductive health. It includes a group of naturally occurring hormones known as gonadotropins, which are produced by the pituitary gland. These hormones, namely follicle-stimulating hormone (FSH) and luteinizing hormone (LH), regulate the reproductive processes in both males and females.

Gonadotrophic APIs are commonly used in various medical applications, particularly in the field of assisted reproductive technology (ART) and fertility treatments. They stimulate the development of ovarian follicles in females, promoting ovulation and enhancing the chances of successful conception. In males, these APIs stimulate the production of sperm cells and support the production of testosterone.

The pharmaceutical industry produces gonadotrophic APIs through advanced biotechnology techniques, such as recombinant DNA technology. This process involves the use of genetically engineered cells, typically from Chinese hamster ovary (CHO) cells, to produce highly pure and bioactive forms of FSH and LH.

Gonadotrophic APIs are typically formulated into injectable preparations, ensuring their efficient delivery and absorption into the bloodstream. These formulations are administered under the guidance of healthcare professionals and require precise dosing to achieve optimal therapeutic outcomes.

Overall, gonadotrophic APIs have revolutionized the field of reproductive medicine, providing effective solutions for infertility and hormonal imbalances. Their usage has helped countless individuals and couples to overcome fertility challenges and realize their dreams of starting a family.


Chorionic gonadotropin (Gonadotrophic), classified under Hormonal Agents


Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.

Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.

Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.

As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.



Chorionic gonadotropin API manufacturers & distributors

Compare qualified Chorionic gonadotropin API suppliers worldwide. We currently have 1 companies offering Chorionic gonadotropin API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
China China CoA, JDMF6 products

When sending a request, specify which Chorionic gonadotropin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).

Use the list above to find high-quality Chorionic gonadotropin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.

We show synonyms and CAS numbers for Chorionic gonadotropin API to help you connect with the right supplier. However, a synonym or CAS number does not always mean it is exactly the same specification. Always confirm the final specs directly with the supplier before placing an order.

Frequently asked questions about Chorionic gonadotropin API


Sourcing

What matters most when sourcing GMP-grade Chorionic gonadotropin (Human)?
Key considerations include confirming GMP compliance and verifying that the material meets regulatory expectations in the US and Canada. Because supply is concentrated among a small group of originator manufacturers, assessing supplier reliability and documentation completeness is essential. It is also important to account for the presence of post‑patent competition and ensure product quality and consistency across suppliers.
Which documents are typically required when sourcing Chorionic gonadotropin (Human) API?
Request the core API documentation set: JDMF (1 company), CoA (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Chorionic gonadotropin (Human) API?
Known or reported manufacturers for Chorionic gonadotropin (Human): . Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Chorionic gonadotropin (Human) API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Chorionic gonadotropin (Human) manufacturers?
Audit reports may be requested for Chorionic gonadotropin (Human): 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Chorionic gonadotropin (Human) API on Pharmaoffer?
Reported supplier count for Chorionic gonadotropin (Human): 1 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Chorionic gonadotropin (Human) API?
Production countries reported for Chorionic gonadotropin (Human): China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Chorionic gonadotropin (Human) usually hold?
Common certifications for Chorionic gonadotropin (Human) suppliers: JDMF (1 company), CoA (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Chorionic gonadotropin (Human) (CAS 9002-61-3) used for?
Chorionic gonadotropin (human) is used to provide luteinizing hormone activity in clinical settings that require stimulation of gonadal steroidogenesis. It is indicated for ovulation induction in appropriately primed anovulatory women, for selected cases of male hypogonadotropic hypogonadism, and for treating prepubertal cryptorchidism without anatomical obstruction.
Which therapeutic class does Chorionic gonadotropin (Human) fall into?
Chorionic gonadotropin (Human) belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Biological Products, Chorionic gonadotropin, Complex Mixtures, Fertility Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Chorionic gonadotropin (Human) mainly prescribed for?
The primary indications for Chorionic gonadotropin (Human): For the treatment of prepubertal cryptorchidism (not due to anatomical obstruction), for the treatment of selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males and for the 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, and who has been appropriately pretreated with human menotropins. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Chorionic gonadotropin (Human) work?
The action of HCG is virtually identical to that of pituitary LH, although HCG appears to have a small degree of FSH activity as well. It stimulates production of gonadal steroid hormones by stimulating the interstitial cells (Leydig cells) of the testis to produce androgens and the corpus luteum of the ovary to produce progesterone.
What should someone know about the safety or toxicity profile of Chorionic gonadotropin (Human)?
Chorionic gonadotropin (human) can cause ovarian hyperstimulation, fluid retention, and may worsen hormone‑sensitive conditions due to its LH‑mediated steroidogenic effects. In males, increased estrogen production may lead to gynecomastia. It should be avoided in patients with hormone‑dependent tumors or non–endocrine causes of undescended testes, and endocrine responses should be monitored during use. The product is highly purified to limit pyrogenic or immunologic reactions, but it remains a biologically derived injectable peptide that undergoes proteolytic degradation and renal and hepatic elimination.
What are important formulation and handling considerations for Chorionic gonadotropin (Human) as an API?
Chorionic gonadotropin (Human) is formulated as a lyophilized peptide hormone for intramuscular or subcutaneous reconstitution, requiring protection from heat and excessive agitation. Reconstituted solutions have limited stability and must be handled under controlled cold‑chain conditions. Because the protein is prone to adsorption and degradation, formulations typically include stabilizers and use low‑interaction primary packaging.
Is Chorionic gonadotropin (Human) a biotech?
Chorionic gonadotropin (Human) is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Chorionic gonadotropin (Human)?
Chorionic gonadotropin (Human) is a protein hormone with inherent sensitivity to heat, agitation, and surface adsorption, so formulations require protection from these stressors. It is typically supplied as a lyophilized powder with stabilizers and low‑interaction packaging to limit degradation. Reconstituted solutions have limited stability and require controlled cold‑chain handling.

Regulatory

Where is Chorionic gonadotropin (Human) approved or in use globally?
Chorionic gonadotropin (Human) is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Chorionic gonadotropin (Human) procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Chorionic gonadotropin (Human). It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Chorionic gonadotropin (Human) included in the PRO Data Insights coverage?
PRO Data Insights coverage for Chorionic gonadotropin (Human): 132 verified transactions across 33 suppliers and 36 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Chorionic gonadotropin (Human)?
Market report availability for Chorionic gonadotropin (Human): Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.