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Testosterone | CAS No: 58-22-0 | GMP-certified suppliers
A medication that addresses primary and hypogonadotropic hypogonadism by restoring deficient androgen levels to support normal male reproductive function and related physiological processes in key global markets.
Therapeutic categories
3-Oxoandrosten (4) DerivativesAnabolic SteroidsAndrogensAndrogens and EstrogensAndrostanesAndrostenes
Generic name
Testosterone
Molecule type
small molecule
CAS number
58-22-0
DrugBank ID
DB00624
Approval status
Approved drug, Investigational drug
ATC code
G03BA03
Primary indications
- Testosterone is indicated to treat primary hypogonadism and hypogonadotropic hypogonadism
Product Snapshot
- Testosterone is supplied as a small‑molecule hormone API for oral, transdermal, topical, injectable, and implantable formulations
- It is used in products targeting primary hypogonadism and hypogonadotropic hypogonadism
- It is authorized in the US, Canada, and the EU, with both approved and investigational statuses depending on the specific formulation
Clinical Overview
Testosterone (CAS 58-22-0) is an endogenous androgen indicated for replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism. Its clinical use focuses on restoring physiologic androgen levels to support normal reproductive function, sexual development, and metabolic processes dependent on androgen signaling. The compound is a 3‑hydroxylated C19 steroid hormone within the androgen class and is also synthesized as an API for regulated therapeutic preparations.
Pharmacologically, testosterone acts by binding to the cytoplasmic androgen receptor, displacing associated heat shock proteins and initiating a conformational change that stabilizes ligand–receptor interaction. The activated complex translocates to the nucleus, interacts with specific DNA response elements, and recruits transcriptional machinery to regulate gene expression. Both testosterone and its metabolite dihydrotestosterone mediate the development and maintenance of primary male reproductive organs and secondary sexual characteristics, including vocal changes, hair distribution, and muscle and fat patterning.
Testosterone exhibits a variable elimination half life ranging from approximately 10 to 100 minutes, influenced by formulation and metabolic pathways. It undergoes extensive hepatic metabolism, with multiple cytochrome P450 isoforms involved, including CYP3A and CYP2C families. The therapeutic index is broad, reflecting the wide physiological concentration range observed in adult males. Secondary exposure risks associated with topical formulations require clear patient counseling to avoid unintentional transfer, particularly to children.
Safety considerations include monitoring for androgen-dependent adverse effects, fluid retention, erythrocytosis, and potential impacts on prostate health. Use should be individualized based on baseline hormonal status, comorbidities, and formulation-specific characteristics. Testosterone is present in numerous approved preparations such as injectable esters, transdermal systems, and topical gels, with regional availability varying.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and residual solvent limits, along with full regulatory documentation such as DMFs or CEPs to support global filing requirements.
Pharmacologically, testosterone acts by binding to the cytoplasmic androgen receptor, displacing associated heat shock proteins and initiating a conformational change that stabilizes ligand–receptor interaction. The activated complex translocates to the nucleus, interacts with specific DNA response elements, and recruits transcriptional machinery to regulate gene expression. Both testosterone and its metabolite dihydrotestosterone mediate the development and maintenance of primary male reproductive organs and secondary sexual characteristics, including vocal changes, hair distribution, and muscle and fat patterning.
Testosterone exhibits a variable elimination half life ranging from approximately 10 to 100 minutes, influenced by formulation and metabolic pathways. It undergoes extensive hepatic metabolism, with multiple cytochrome P450 isoforms involved, including CYP3A and CYP2C families. The therapeutic index is broad, reflecting the wide physiological concentration range observed in adult males. Secondary exposure risks associated with topical formulations require clear patient counseling to avoid unintentional transfer, particularly to children.
Safety considerations include monitoring for androgen-dependent adverse effects, fluid retention, erythrocytosis, and potential impacts on prostate health. Use should be individualized based on baseline hormonal status, comorbidities, and formulation-specific characteristics. Testosterone is present in numerous approved preparations such as injectable esters, transdermal systems, and topical gels, with regional availability varying.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and residual solvent limits, along with full regulatory documentation such as DMFs or CEPs to support global filing requirements.
Identification & chemistry
| Generic name | Testosterone |
|---|---|
| Molecule type | Small molecule |
| CAS | 58-22-0 |
| UNII | 3XMK78S47O |
| DrugBank ID | DB00624 |
Pharmacology
| Summary | Testosterone primarily binds and activates the androgen receptor, triggering nuclear translocation and transcription of genes involved in male reproductive tissue development and secondary sexual characteristics. Its activity is mediated by both testosterone and its metabolite dihydrotestosterone, with additional weaker interactions at estrogen receptor alpha and the mineralocorticoid receptor. Overall pharmacodynamic effects reflect androgen‑dependent regulation of growth, differentiation, and tissue maintenance in androgen‑responsive organs. |
|---|---|
| Mechanism of action | The androgen receptor exists in the cytoplasm bound to the heat shock proteins HSP90, HSP70, and other chaperones.After binding to an androgen, the androgen receptor dissociates from HSP90 and undergoes a conformational change to slow the rate of dissociation from the androgen receptor.The androgen-receptor complex is transported into the nucleus where it binds to DNA and recruits other transcriptional regulators to form a pre-initiation complex and eventually induce expression of specific genes. Testosterone and its active metabolite dihydrotestosterone (DHT) antagonize the androgen receptor to develop masculine sex organs including the prostate, seminal vesicles, penis, and scrotum. Antagonism of the androgen receptor is also responsible for the development of secondary sexual characteristics including facial and body hair, enlargement of the larynx, thickening of the vocal cords, and changes in muscle and fat distribution. |
| Pharmacodynamics | Testosterone antagonizes the androgen receptor to induce gene expression that causes the growth and development of masculine sex organs and secondary sexual characteristics.The duration of action of testosterone is variable from patient to patient with a half life of 10-100 minutes.The therapeutic index is wide considering the normal testosterone levels in an adult man range from 300-1000ng/dL.Counsel patients regarding the risk of secondary exposure of testosterone topical products to children. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Androgen receptor | Humans | agonist |
| Estrogen receptor alpha | Humans | inhibitor |
| Mineralocorticoid receptor | Humans | ligand |
ADME / PK
| Absorption | A single 100mg topical dose of testosterone has an AUC of 10425±5521ng\*h/dL and a C<sub>max</sub> of 573±284ng/dL.Testosterone is approximately 10% bioavailable topically. |
|---|---|
| Half-life | The half life of testosterone is highly variable, ranging from 10-100 minutes. |
| Protein binding | Testosterone is 40% bound to sex hormone binding globulin, 2% unbound, and the remainder is bound to albumin and other proteins. |
| Metabolism | Testosterone is metabolized to 17-keto steroids through two different pathways. The major active metabolites are estradiol and dihydrotestosterone (DHT). Testosterone can be hydroxylated at a number of positions by CYP3A4, CYP2B6, CYP2C9, and CYP2C19;glucuronidated by UGT2B17;sulfated;converted to estradiol by aromatase;converted to dihydrotestosterone (DHT) by 5α-reductase;metabolized to androstenedione by CYP3A4, CYP2C9, and CYP2C19;or converted to DHT glucuronide. Androstenedione undergoes metabolism by aromatase to form estrone,which undergoes a reversible reaction to form estradiol.Androstenedione can also be converted to 5α-androstanedioneby 5α-reductase,which can be further metabolized to 5α-androsterone. DHT can be glucuronidatedor sulfated, or metabolized to 5α-androstanediol,androstane-3α,17β-diol, or androstane-3β,17β-diol.DHT can also be reversibly converted to 5α-androstanedione. |
| Route of elimination | 90% of an intramuscular dose is eliminated in urine, mainly as glucuronide and sulfate conjugates.6% is eliminated in feces, mostly as unconjugated metabolites. |
| Volume of distribution | The volume of distribution of testosterone in elderly men is 80.36±24.51L. |
| Clearance | The mean metabolic clearance in middle aged men is 812±64L/day. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity favor non‑aqueous IM solutions, transdermal systems, and topical gels rather than conventional aqueous oral formulations.
- Solid steroidal small molecule is chemically stable but requires protection from oxidation and light during processing and storage.
- Transdermal and topical products rely on permeation enhancers and controlled‑release matrices to achieve consistent systemic delivery.
Regulatory status
| Lifecycle | The API’s core US and Canadian patents expired between 2010 and 2020, indicating that major exclusivities have lapsed across its primary markets. With products already marketed in the US, Canada, and the EU, the API is in a mature, post‑exclusivity phase. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Testosterone is supplied by numerous originator and legacy developers alongside a wide range of generic manufacturers and packagers, reflecting a mature and highly diversified production base. Branded products such as transdermal systems are established in the US, Canada, and EU, but no longer rely on active patent protection. With key patents expired across these markets, broad generic competition is already well established. |
|---|
Safety
| Toxicity | Data regarding an overdose with a topical testosterone product is not readily available.In the case of overdose with an injectable product, patients may present with a cerebrovascular event.Treat overdoses by stopping testosterone products, washing off any topical products with soap and water, and initiating symptomatic and supportive treatments. |
|---|
High Level Warnings:
- Overexposure data for topical formulations are limited
- Injectable testosterone overdose has been associated with cerebrovascular events
- Handling protocols should minimize dermal and parenteral exposure due to systemic absorption potential
Testosterone is a type of Androgens
Androgens are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in hormone replacement therapy and various other medical applications. They are a class of hormones that primarily include testosterone and its derivatives, which are responsible for the development and maintenance of male characteristics in the body.
Androgens are commonly used in the treatment of conditions such as hypogonadism, delayed puberty, androgen deficiency syndromes, and certain types of breast cancer. They work by binding to and activating the androgen receptors in cells, regulating gene expression and influencing the development and functioning of various tissues and organs.
Pharmaceutical companies produce androgens as API compounds to ensure precise dosage and efficacy in pharmaceutical formulations. These APIs undergo rigorous testing and quality control measures to meet regulatory standards and ensure patient safety.
The availability of androgens as APIs enables the formulation of different dosage forms such as tablets, injections, gels, and transdermal patches. These formulations provide healthcare professionals with various options for administration, allowing them to tailor treatment regimens according to individual patient needs.
It is essential for pharmaceutical companies to maintain strict quality control and adhere to Good Manufacturing Practices (GMP) during the production of androgens APIs. This ensures consistent potency, purity, and bioavailability of the APIs, ultimately leading to safe and effective medications for patients.
In conclusion, androgens are a vital subcategory of pharmaceutical APIs used in hormone replacement therapy and the treatment of various medical conditions. Their precise production and formulation allow for effective therapeutic interventions, promoting optimal patient outcomes.
Testosterone (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.
Frequently asked questions about Testosterone API
Sourcing
What matters most when sourcing GMP-grade Testosterone?
Key considerations include verifying compliance with US, Canadian, and EU GMP and confirming that the manufacturer meets relevant regulatory and documentation requirements. Given the mature and diversified supply base, assessing the supplier’s consistency, quality systems, and traceability is essential. Established generic competition also makes it important to evaluate batch-to-batch reliability and regulatory inspection history.
Which documents are typically required when sourcing Testosterone API?
Request the core API documentation set: CoA (19 companies), USDMF (11 companies), GMP (10 companies), WC (5 companies), MSDS (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Testosterone API?
Known or reported manufacturers for Testosterone: Caesar & Loretz GmbH (CAELO), LGM Pharma, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Testosterone 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 Testosterone manufacturers?
Audit reports may be requested for Testosterone: 10 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Testosterone API on Pharmaoffer?
Reported supplier count for Testosterone: 19 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Testosterone API?
Production countries reported for Testosterone: India (8 producers), China (5 producers), United States (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Testosterone usually hold?
Common certifications for Testosterone suppliers: CoA (19 companies), USDMF (11 companies), GMP (10 companies), WC (5 companies), MSDS (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Testosterone (CAS 58-22-0) used for?
Testosterone is used for replacement therapy in adult males with primary hypogonadism or hypogonadotropic hypogonadism to restore physiologic androgen levels. It supports normal reproductive function, sexual development, and metabolic processes dependent on androgen signaling.
Which therapeutic class does Testosterone fall into?
Testosterone belongs to the following therapeutic categories: 3-Oxoandrosten (4) Derivatives, Anabolic Steroids, Androgens, Androgens and Estrogens, Androstanes. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Testosterone mainly prescribed for?
The primary indications for Testosterone: Testosterone is indicated to treat primary hypogonadism and hypogonadotropic hypogonadism. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Testosterone work?
The androgen receptor exists in the cytoplasm bound to the heat shock proteins HSP90, HSP70, and other chaperones.After binding to an androgen, the androgen receptor dissociates from HSP90 and undergoes a conformational change to slow the rate of dissociation from the androgen receptor.The androgen-receptor complex is transported into the nucleus where it binds to DNA and recruits other transcriptional regulators to form a pre-initiation complex and eventually induce expression of specific genes.
Testosterone and its active metabolite dihydroTestosterone (DHT) antagonize the androgen receptor to develop masculine sex organs including the prostate, seminal vesicles, penis, and scrotum.
Antagonism of the androgen receptor is also responsible for the development of secondary sexual characteristics including facial and body hair, enlargement of the larynx, thickening of the vocal cords, and changes in muscle and fat distribution.
What should someone know about the safety or toxicity profile of Testosterone?
Testosterone can produce androgen‑dependent adverse effects such as fluid retention, erythrocytosis, and prostate‑related changes, so clinical use requires routine monitoring. Topical products pose a risk of secondary exposure through dermal transfer, and handling should minimize skin contact due to systemic absorption potential. Overexposure data for topical formulations are limited, but injectable overdose has been associated with cerebrovascular events. Proper handling and individualized dosing reduce unintended systemic effects.
What are important formulation and handling considerations for Testosterone as an API?
Key considerations include its low aqueous solubility and moderate lipophilicity, which support use in non‑aqueous intramuscular solutions, transdermal systems, and topical gels. The solid steroid requires protection from oxidation and light during processing and storage. Transdermal and topical forms depend on permeation enhancers and controlled‑release matrices to maintain consistent systemic exposure. Handling should account for its metabolic sensitivity and ensure stable conditions that prevent degradation.
Is Testosterone a small molecule?
Testosterone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Testosterone?
Low aqueous solubility and moderate lipophilicity limit the suitability of conventional aqueous oral formulations and can affect dissolution and consistent exposure. The solid steroid is chemically stable but requires protection from oxidation and light during processing and storage. These factors should be considered when designing or handling any oral dosage form.
Regulatory
Where is Testosterone approved or in use globally?
Testosterone is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Testosterone right now?
Testosterone is an established prescription and controlled substance in the US, Canada, and the EU, with multiple approved formulations regulated under each region’s medicinal product frameworks. Core substance patents have expired, and the API itself is off‑patent, though specific formulations, delivery systems, or manufacturing processes may still be protected by individual patents.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Testosterone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Testosterone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Testosterone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Testosterone: 2217 verified transactions across 377 suppliers and 298 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Testosterone?
Market report availability for Testosterone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
