- Raw materials
- Hormonal Agents
- Anti-androgens
- Cyproterone acetate
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Cyproterone acetate API Manufacturers & Suppliers
12 verified results
Commercial-scale Suppliers
Employees: 50+
All certificates
All certificates
All certificates
Employees: 3,500+
All certificates
All certificates
Employees: 400+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Cyproterone acetate | CAS No: 427-51-0 | GMP-certified suppliers
A medication that provides palliative treatment for advanced prostatic carcinoma by modulating androgen effects and reproductive hormones, with applications in hormonal and antiandrogen therapies.
Therapeutic categories
Primary indications
- For the palliative treatment of patients with advanced prostatic carcinoma
Product Snapshot
- Cyproterone acetate is available in multiple formulations including oral tablets, injectable solutions, and suspensions suitable for intramuscular and parenteral administration
- It is primarily indicated for the palliative treatment of advanced prostatic carcinoma
- The product is approved for use in the Canadian market, with both approved and investigational status
Clinical Overview
Clinically, cyproterone acetate is indicated primarily for the palliative treatment of advanced prostatic carcinoma. It is also used in managing hypersexuality in males and, in combination with estrogens, for severe acne and hirsutism in females. Its clinical applications leverage its ability to modulate androgen effects and reproductive hormones.
Pharmacodynamically, cyproterone acetate functions as an antiandrogen by antagonizing androgen receptor binding. It inhibits the action of testosterone and its potent metabolite dihydrotestosterone (DHT) on target tissues. The mechanism of action involves direct blockade of DHT binding to androgen receptors, particularly in prostatic carcinoma cells, preventing androgen-mediated cellular proliferation. Additionally, cyproterone acetate exerts negative feedback on the hypothalamo-pituitary axis, suppressing luteinizing hormone secretion, which leads to decreased testicular testosterone synthesis.
Key absorption, distribution, metabolism, and excretion (ADME) parameters are marked by its oral bioavailability and metabolism predominantly via hepatic cytochrome P450 enzymes, including CYP3A4. It acts as both a substrate and weak inhibitor of CYP3A4, which may have implications for drug-drug interactions.
Regarding safety, cyproterone acetate is associated with potential hepatotoxicity and thromboembolic risks, requiring careful monitoring during treatment. It is contraindicated in patients with liver impairment and known hypersensitivity. Due to its hormonal activity, it may also affect carbohydrate metabolism and coagulation profiles.
Notable formulations often combine cyproterone acetate with estrogens, particularly in contraceptive applications for females, managing androgen-related dermatological conditions.
From an API sourcing perspective, establishing robust quality control is essential, especially confirming identity, potency, and purity consistent with regulatory standards. Given its steroidal structure and CYP450 interactions, sourcing from manufacturers with validated synthetic routes and comprehensive impurity profiling is critical to ensure compliance and batch-to-batch consistency.
Identification & chemistry
| Generic name | Cyproterone acetate |
|---|---|
| Molecule type | Small molecule |
| CAS | 427-51-0 |
| UNII | 4KM2BN5JHF |
| DrugBank ID | DB04839 |
Pharmacology
| Summary | Cyproterone acts as an antiandrogen by blocking androgen receptors, preventing the binding of dihydrotestosterone and testosterone in target tissues such as prostatic carcinoma cells. It also suppresses luteinizing hormone secretion via negative feedback on the hypothalamo-pituitary axis, leading to reduced testicular testosterone production. These mechanisms contribute to its therapeutic use in managing advanced prostatic carcinoma. |
|---|---|
| Mechanism of action | The direct antiandrogenic effect of cyproterone is blockage of the binding of dihydrotestosterone to the specific receptors in the prostatic carcinoma cell. In addition, cyproterone exerts a negative feed-back on the hypothalamo-pituitary axis, by inhibiting the secretion of luteinizing hormone resulting in diminished production of testicular testosterone. |
| Pharmacodynamics | Cyproterone is an antiandrogen. It suppresses the actions of testosterone (and its metabolite dihydrotestosterone) on tissues. It acts by blocking androgen receptors which prevents androgens from binding to them and suppresses luteinizing hormone (which in turn reduces testosterone levels). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Androgen receptor | Humans | antagonist |
| Prostate-specific antigen | Humans |
ADME / PK
| Absorption | Completely absorbed following oral administration. |
|---|---|
| Half-life | Elimination Following oral or intramuscular administration, the plasma half-life is 38 and 96 hours, respectively. |
| Metabolism | Primarily hepatic. Cyproterone acetate is metabolized by the CYP3A4 enzyme, forming the active metabolite 15beta-hydroxycyproterone acetate, which retains its antiandrogen activity, but has reduced progestational activity. |
| Route of elimination | It is excreted approximately 60% in the bile and 33% through the kidneys. |
Formulation & handling
- Cyproterone acetate is a small molecule steroid available for oral and parenteral administration, including tablets and intramuscular injections. Its low aqueous solubility and moderate lipophilicity (LogP 3.64) suggest formulation challenges for bioavailability and require appropriate solubilizing strategies. Food intake enhances tolerability and absorption, so oral dosing is recommended after meals and with avoidance of alcohol.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is marketed in Canada with key patents expired, indicating a mature market with availability of generic alternatives. Ongoing use is supported by established clinical data and regulatory approvals. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Cyproterone acetate involves multiple originator companies producing branded products primarily in the Canadian market. Branded formulations such as Alti-cpa, Androcur, Androcur Depot, Cléo -35, and Cyestra-35 indicate established presence across hormone-related therapies. Patent expiration status is not specified, but the availability of multiple branded products suggests potential for existing generic competition. |
|---|
Cyproterone acetate is a type of Anti-androgens
Anti-androgens are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various androgen-dependent conditions. These medications work by blocking or inhibiting the activity of androgens, which are male sex hormones like testosterone. Anti-androgens are primarily employed in the management of conditions such as prostate cancer, hirsutism, androgenetic alopecia, and certain types of acne.
There are different types of anti-androgens, including steroidal and non-steroidal variants. Steroidal anti-androgens, such as cyproterone acetate, possess a similar chemical structure to testosterone and competitively bind to androgen receptors, thereby preventing the binding of testosterone. On the other hand, non-steroidal anti-androgens, like bicalutamide and flutamide, act by blocking the androgen receptors directly.
These APIs are typically synthesized through complex chemical processes in pharmaceutical manufacturing facilities, ensuring high purity and quality. Anti-androgens may be formulated into various dosage forms, such as tablets, capsules, or injections, for easy administration and absorption in the body.
The effectiveness of anti-androgens in mitigating androgen-related disorders has made them a crucial component in medical practice. Patients who require androgen suppression therapy can benefit from these medications, as they help reduce the effects of androgens on target tissues and cells.
Overall, anti-androgens play a crucial role in the treatment of androgen-dependent conditions, and their pharmaceutical APIs are engineered to provide optimal therapeutic outcomes. These pharmaceutical ingredients are a result of extensive research and development, ensuring their efficacy, safety, and compliance with regulatory standards.
Cyproterone acetate (Anti-androgens), 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.
Cyproterone acetate API manufacturers & distributors
Compare qualified Cyproterone acetate API suppliers worldwide. We currently have 12 companies offering Cyproterone acetate API, with manufacturing taking place in 8 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 | 42 products |
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, WC | 164 products |
| Curia | Producer | United States | Spain | CEP, CoA, GMP, MSDS | 106 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP | 58 products |
| Hunan Yuxin Pharmaceutica... | Producer | China | China | CoA | 14 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor De México | Producer | Mexico | Mexico | CEP, CoA, FDA | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Zhejiang Xianju | Producer | China | China | CEP, CoA, FDA | 17 products |
| Zhejiang Xianju Xianle | Producer | China | China | CEP, CoA, GMP, WC | 2 products |
When sending a request, specify which Cyproterone acetate 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 Cyproterone acetate 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.
