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Flutamide | CAS No: 13311-84-7 | GMP-certified suppliers
A medication that manages locally confined and metastatic prostate carcinoma by inhibiting androgen receptor activity to slow tumor progression in advanced prostate cancer cases.
Therapeutic categories
Primary indications
- For the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate
Product Snapshot
- Flutamide is an oral non-steroidal anti-androgen formulated primarily as capsules and various tablet forms including film-coated and coated tablets
- It is indicated for the management of locally confined Stage B2-C and Stage D2 metastatic carcinoma of the prostate
- Flutamide is approved and investigational in key regulatory markets including the US and Canada
Clinical Overview
Pharmacodynamically, flutamide operates by antagonizing androgen receptor activity. It inhibits androgen uptake and nuclear androgen binding within target tissues, effectively blocking the action of both endogenous and exogenous testosterone. This mode of action reduces androgen-stimulated prostatic DNA synthesis, a key driver of prostate carcinoma progression. The clinical relevance is rooted in the androgen sensitivity of prostatic carcinoma, where interrupting androgen signaling can retard tumor growth. Notably, flutamide administration has been associated with increased plasma levels of testosterone and estradiol, reflecting endocrine feedback mechanisms.
Regarding absorption, distribution, metabolism, and excretion (ADME), flutamide is subject to metabolic processing involving cytochrome P-450 enzymes including CYP1A2, CYP3A4, and CYP3A5 isoforms, which should be considered in drug-drug interaction assessments. Excretion is primarily renal. The metabolic profile implicates flutamide as a substrate of multiple cytochrome P-450 pathways, necessitating vigilance during co-administration with other agents affecting these enzymes.
Safety considerations include monitoring for hepatotoxicity and methemoglobinemia, adverse effects previously reported in association with flutamide. Close clinical surveillance is advised to manage potential toxicity and ensure patient safety.
Flutamide is listed among approved hormonal antineoplastic agents, and it is utilized predominantly in endocrine therapy targeting prostate cancer. It shares a similar antiandrogenic potency to cyproterone in preclinical species such as rodents and canines.
When sourcing flutamide as an active pharmaceutical ingredient (API), attention to quality standards is critical. Manufacturers should verify compliance with pharmacopeial specifications, ensure batch-to-batch consistency, and confirm the absence of impurities, including related substances. Given its metabolism via cytochrome P-450 enzymes and potential toxicity profile, stringent control of the API’s purity and stability is essential to maintain safe and effective drug product manufacture.
Identification & chemistry
| Generic name | Flutamide |
|---|---|
| Molecule type | Small molecule |
| CAS | 13311-84-7 |
| UNII | 76W6J0943E |
| DrugBank ID | DB00499 |
Pharmacology
| Summary | Flutamide is a nonsteroidal antiandrogen that competitively binds to the androgen receptor, inhibiting the action of endogenous and exogenous testosterone. It suppresses testosterone-stimulated prostatic DNA synthesis by blocking androgen uptake and nuclear binding in prostate tissue. Flutamide is primarily utilized to counteract androgen effects in androgen-sensitive prostatic carcinoma. |
|---|---|
| Mechanism of action | Flutamide is a nonsteroidal antiandrogen that blocks the action of both endogenous and exogenous testosterone by binding to the androgen receptor. In addition Flutamide is a potent inhibitor of testosterone-stimulated prostatic DNA synthesis. Moreover, it is capable of inhibiting prostatic nuclear uptake of androgen. |
| Pharmacodynamics | Flutamide is a nonsteroidal antiandrogen. In animal studies, flutamide demonstrates potent antiandrogenic effects. It exerts its antiandrogenic action by inhibiting androgen uptake and/or by inhibiting nuclear binding of androgen in target tissues or both. Prostatic carcinoma is known to be androgen-sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen, e.g. castration. Elevations of plasma testosterone and estradiol levels have been noted following flutamide administration. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Androgen receptor | Humans | antagonist |
| Aryl hydrocarbon receptor | Humans | agonist |
| Nuclear receptor subfamily 1 group I member 2 | Humans |
ADME / PK
| Absorption | Rapidly and completely absorbed. |
|---|---|
| Half-life | The plasma half-life for the alpha-hydroxylated metabolite of flutamide (an active metabolite) is approximately 6 hours. |
| Protein binding | 94-96% |
| Metabolism | Flutamide is rapidly and extensively metabolized, with flutamide comprising only 2.5% of plasma radioactivity 1 hour after administration. |
| Route of elimination | Flutamide and its metabolites are excreted mainly in the urine with only 4.2% of a single dose excreted in the feces over 72 hours. |
Formulation & handling
- Flutamide is a small molecule drug administered orally in capsule or tablet forms.
- It exhibits low water solubility and moderate lipophilicity, which may impact dissolution and formulation strategies.
- Flutamide’s absorption is not affected by food, allowing flexibility in dosing relative to meals.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is marketed in both Canada and the US, with its key patents having expired, placing the product in a mature market phase characterized by generic competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Flutamide is manufactured by multiple companies including original producers and generic manufacturers, reflecting a diversified supply base. Branded products are primarily present in the US and Canadian markets, with several brand names in circulation. Patent expiry has facilitated the entry of generic competition, as evidenced by the number of generic manufacturers and repackagers supplying the market. |
|---|
Safety
| Toxicity | In animal studies with flutamide alone, signs of overdose included hypoactivity, piloerection, slow respiration, ataxia, and/or lacrimation, anorexia, tranquilization, emesis, and methemoglobinemia. |
|---|
- Potential for central nervous system depression and respiratory effects observed in toxicity studies
- Signs of overdose in animal models include methemoglobinemia and gastrointestinal disturbances
- Handle with appropriate protective equipment to minimize exposure risk due to systemic toxicity
Flutamide 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.
Flutamide (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.
Flutamide API manufacturers & distributors
Compare qualified Flutamide API suppliers worldwide. We currently have 8 companies offering Flutamide API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Coral Drugs | Producer | India | India | CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, WC, WHO-GMP | 25 products |
| Curia | Producer | United States | Italy | CEP, CoA, GMP, MSDS, USDMF | 106 products |
| Derivados Quimicos | Producer | Spain | Spain | CEP, CoA, FDA, GMP, JDMF | 18 products |
| Euticals | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, USDMF | 48 products |
| Fermion | Producer | Finland | Finland | BSE/TSE, CEP, CoA, GDP, GMP, USDMF | 29 products |
| Nobilus Ent | Producer | Poland | Poland | CoA, GMP | 5 products |
When sending a request, specify which Flutamide 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 Flutamide 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.
