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Gestodene | CAS No: 60282-87-3 | GMP-certified suppliers
A medication that provides hormonal contraceptive effects for female reproductive control by suppressing ovulation and modifying cervical and endometrial conditions.
Therapeutic categories
Product Snapshot
- Gestodene is an oral small molecule formulation available in various tablet forms including film coated, delayed release, and sugar coated
- Its primary therapeutic use is in hormonal contraceptive applications
- Gestodene is currently investigational and not approved for commercial use in the US market
Clinical Overview
Pharmacologically, gestodene functions as a progestin, a class of compounds that mimic the activity of natural progesterone. This activity primarily involves modulation of the hypothalamic-pituitary-ovarian axis, resulting in suppression of ovulation, alteration of cervical mucus viscosity to impede sperm penetration, and changes in the endometrial lining to reduce the likelihood of implantation. Gestodene’s pharmacodynamic profile reflects its role in combination formulations, where it is often paired with ethinylestradiol to enhance contraceptive efficacy.
From a metabolic standpoint, gestodene is a substrate and inhibitor of multiple cytochrome P450 enzymes, including CYP2C19, CYP3A4, CYP3A5, and CYP3A7. These interactions may influence the metabolism of co-administered drugs metabolized by these pathways. The drug’s precise absorption, distribution, metabolism, and excretion (ADME) parameters are not fully described here but relate to its steroidal nature and oral contraceptive use.
Safety considerations primarily focus on the established class effects of combined hormonal contraceptives, including potential risks for thromboembolic events, cardiovascular adverse reactions, and hormone-sensitive conditions. Toxicological profiles and risk assessments should be based on comprehensive clinical data and regulatory evaluations.
Notable commercially available products incorporating gestodene include Meliane, combining 20 mcg ethinylestradiol with 75 mcg gestodene, and Gynera, comprising 30 mcg ethinylestradiol with 75 mcg gestodene. These formulations reflect standard dosing for oral hormonal contraceptives within certain regulatory frameworks.
From a sourcing and quality perspective, procurement of gestodene API requires adherence to stringent pharmaceutical grade standards, including verification of chemical purity, stereochemical integrity, and compliance with regulatory guidelines for hormonal active ingredients. Suppliers should provide comprehensive documentation that meets global regulatory requirements to ensure consistent quality and safety in finished pharmaceutical products.
Identification & chemistry
| Generic name | Gestodene |
|---|---|
| Molecule type | Small molecule |
| CAS | 60282-87-3 |
| UNII | 1664P6E6MI |
| DrugBank ID | DB06730 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Progesterone receptor | Humans | binder, activator |
ADME / PK
| Absorption | in vitro 99% using 3H=R5020 / in vivo similar to progesterone |
|---|---|
| Half-life | 16 to 18 hrs. |
Formulation & handling
- Gestodene is a small molecule estrogen derivative formulated exclusively for oral administration in various tablet forms.
- It exhibits low water solubility (5.81 mg/L) and moderate lipophilicity (LogP 3.46), which should be considered in formulation for optimal bioavailability.
- As a steroidal compound, stability under standard storage conditions is expected, but sensitivity to light or heat should be evaluated during handling and manufacturing.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the US with patent protection expected to expire in , indicating transition towards generic competition and increased market maturity. Post-patent expiry, the API is anticipated to experience expanded availability through generic formulations. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Gestodene includes originator companies supplying branded products predominantly in the US market, with Myvlar as a noted example. While branded presence appears concentrated in the US, patent expirations suggest the potential for existing or upcoming generic competition. No substantial data indicates a broad EU or other international branded market presence. |
|---|
Gestodene is a type of Progestagens
Progestagens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormonal therapies and contraceptives. Also known as progestins, these synthetic compounds mimic the effects of the naturally occurring hormone progesterone in the body.
Progestagens are widely used in various medical applications due to their ability to regulate the menstrual cycle, support pregnancy, and prevent undesired conception. They function by binding to progesterone receptors and modulating the reproductive system's activity.
In addition to their contraceptive properties, progestagens are utilized in hormone replacement therapy (HRT) to alleviate symptoms associated with menopause, such as hot flashes and mood swings. They can also be prescribed to treat irregular menstruation, endometriosis, and certain types of cancer, including breast and uterine cancers.
Pharmaceutical companies develop progestagens in different formulations, including oral tablets, injections, and implants, to cater to diverse patient needs. These formulations offer varying durations of action, allowing healthcare professionals to tailor treatment regimens to individual patients.
While progestagens are generally well-tolerated, they may be associated with certain side effects, such as weight gain, bloating, and breast tenderness. It is essential for healthcare providers to assess patient medical history and monitor their response to progestagen therapy closely.
In conclusion, progestagens are a vital class of pharmaceutical APIs with significant therapeutic applications. Their versatility and effectiveness in hormonal regulation make them a cornerstone of various hormonal therapies, providing patients with safe and reliable options for contraception, HRT, and managing reproductive disorders.
Gestodene (Progestagens), 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.
Gestodene API manufacturers & distributors
Compare qualified Gestodene API suppliers worldwide. We currently have 5 companies offering Gestodene API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, USDMF | 42 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Industriale Chimica | Producer | Italy | Unknown | CEP, CoA, FDA, GMP | 33 products |
| Libbs Farma | Producer | Brazil | Brazil | CEP, CoA, GMP | 3 products |
| Qinhuangdao Zizhu | Producer | China | China | CEP, CoA, FDA, USDMF | 10 products |
When sending a request, specify which Gestodene 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 Gestodene 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.
