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Urofollitropin | CAS No: 97048-13-0 | GMP-certified suppliers
A medication that supports treatment of female infertility by stimulating ovarian follicular growth to aid ovulation induction and assisted reproductive technologies.
Therapeutic categories
Primary indications
- For treatment of female infertility
Product Snapshot
- Urofollitropin is a parenteral injectable peptide available primarily as lyophilized powder for solution and liquid injection formulations
- It is indicated for the treatment of female infertility
- The product is approved for use in the Canadian market, including veterinary approval
Clinical Overview
Clinically, urofollitropin is indicated for the treatment of female infertility. It is primarily employed to stimulate ovarian follicular growth in women who do not have primary ovarian failure. The hormone acts by promoting follicle development, which may then enable ovulation induction or the production of multiple follicles for assisted reproductive technologies such as gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).
Pharmacodynamically, urofollitropin mimics the endogenous FSH critical for follicular recruitment and maturation. Mechanistically, FSH binds to the follicle stimulating hormone receptor (FSHR), a G protein-coupled receptor located on ovarian granulosa cells. This receptor-ligand interaction activates intracellular signaling cascades, particularly the PI3K/Akt pathway, which modulates cellular metabolism, survival, and maturation processes necessary for follicle development.
Key absorption, distribution, metabolism, and excretion (ADME) parameters are not extensively characterized in published literature for this urinary-derived protein due to its direct biological activity and parenteral administration route. Urofollitropin is administered via subcutaneous injection, facilitating rapid systemic availability.
Safety considerations include monitoring for ovarian hyperstimulation syndrome (OHSS) and multiple pregnancies, which represent significant adverse risk factors associated with gonadotropin therapy. Immunogenic reactions, although rare, can occur due to the proteinaceous nature of the molecule.
Urofollitropin is marketed under various brand names globally and is approved for human use as well as veterinary applications in certain jurisdictions. It falls under several pharmacological classes, including pituitary hormones and gonadotropins.
When sourcing urofollitropin API, quality considerations are critical due to its biological origin. Manufacturers should ensure stringent purification processes to minimize protein impurities and contaminating urinary constituents. Compliance with pharmacopeial standards and regulatory guidelines for biologically derived gonadotropins is essential to guarantee consistency, potency, and safety for pharmaceutical formulation.
Identification & chemistry
| Generic name | Urofollitropin |
|---|---|
| Molecule type | Biotech |
| CAS | 97048-13-0 |
| UNII | W9BB98U6HP |
| DrugBank ID | DB00094 |
Pharmacology
| Summary | Urofollitropin acts as a follicle-stimulating hormone (FSH) agonist targeting the follicle-stimulating hormone receptor, a G-protein coupled receptor. Activation of this receptor triggers the PI3K/Akt signaling pathway, promoting ovarian follicular growth and maturation. It is used therapeutically to stimulate follicular development in women with infertility due to insufficient endogenous FSH activity. |
|---|---|
| Mechanism of action | FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells. |
| Pharmacodynamics | Used for the treatment of female infertility, urofollitropin or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of urofollitropin is the primary hormone responsible for follicular recruitment and development. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Follicle-stimulating hormone receptor | Humans | agonist |
ADME / PK
| Absorption | 74% |
|---|---|
| Half-life | Circulation half life of 3-4 hours, elimination half life of 35-40 hours |
| Route of elimination | Via liver and kidneys |
| Volume of distribution | Time to peak in plasma: IM: 17 hours (single dose), 11 hours (multiple doses) SubQ: 21 hours (single dose), 10 hours (multiple doses) |
Formulation & handling
- Urofollitropin is a biotech peptide administered via intramuscular or subcutaneous injection, requiring reconstitution from powder to solution for use. Due to its biologic nature, maintain cold chain storage and handle under controlled conditions to preserve stability and efficacy. Oral administration is not applicable, and formulations are sensitive to proteolytic degradation, necessitating careful aseptic preparation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patent in the United States expired in June 2015, allowing generic competition. The product is marketed in Canada, where market maturity is influenced by patent status and regulatory approvals. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Urofollitropin involves multiple originator companies, including Serono Laboratories Inc. and Ferring Pharmaceuticals Inc., with packaging distributed across several specialized providers. Branded products are present primarily in the Canadian market. Patent information indicates protection through mid-2015 in the United States, suggesting that generic competition may already exist or be forthcoming. |
|---|
Urofollitropin 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.
Urofollitropin (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.
Urofollitropin API manufacturers & distributors
Compare qualified Urofollitropin API suppliers worldwide. We currently have 1 companies offering Urofollitropin 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.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Kraeber & Co GmbH | Producer | Germany | Germany | CoA, GDP, GMP, ISO9001, MSDS | 12 products |
When sending a request, specify which Urofollitropin 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 Urofollitropin 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.
