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Prasterone | CAS No: 53-43-0 | GMP-certified suppliers
A medication that supports management of menopausal dyspareunia and shows potential benefits across skin aging, bone density, and certain immune related conditions.
Therapeutic categories
Primary indications
- DHEA is taken as a supplement for a variety of unsubstantiated indications
- The following indications have shown promise and are backed up by some scientific evidence: schizophrenia (DHEA may be more effective in women than men)
- Improving the appearance of older people’s skin (taking DHEA by mouth seems to increase skin thickness and moisture, and decrease facial “age spots” in elderly men and women)
- Improving ability to achieve an erection in men with sexual dysfunction
Product Snapshot
- Prasterone is supplied as oral and vaginal small‑molecule hormone formulations, including inserts and kits
- It is utilized in markets for hormone‑related and investigational applications such as skin aging, sexual dysfunction, autoimmune symptoms, and bone‑density support
- It is available in the EU, US, and Canada with mixed regulatory status spanning approved, investigational, and nutraceutical categories
Clinical Overview
Prasterone functions as a prohormone for downstream androgens and estrogens. Following conversion from cholesterol via P450scc and CYP17A1, it can be metabolized to androstenedione, testosterone, estrone, and estradiol. DHEA‑S serves as a circulating reservoir that can be desulfated in peripheral tissues. Its endocrine activity influences reproductive, metabolic, and immune pathways, and circulating levels may reflect adrenal functional status.
Absorption and distribution characteristics vary by route, with oral administration subject to extensive first‑pass metabolism and high conversion to DHEA‑S. The compound undergoes hepatic and peripheral biotransformation through multiple cytochrome P450 pathways, including CYP3A isoenzymes. Both DHEA and its sulfate are substrates for transporters such as OATP1B1, OATP1B3, and BCRP. Elimination occurs through conjugation and renal excretion of metabolites.
Safety considerations include androgenic or estrogenic effects related to downstream metabolites, with potential impacts on hair growth, acne, or menstrual patterns. Endocrine‑active properties warrant caution in hormone‑sensitive conditions. Elevated DHEA‑S levels can be a marker of adrenal hyperactivity, congenital adrenal hyperplasia, or polycystic ovary syndrome. Toxicity data for supraphysiologic exposures in humans remain limited, and drug interaction potential exists due to involvement of CYP3A pathways.
Prasterone is marketed in the United States as the intravaginal product Intrarosa. When sourcing the active pharmaceutical ingredient, procurement teams should verify steroidal identity, assay purity, and impurity profiles consistent with regulatory expectations for hormone APIs, with attention to sulfated and oxidative degradants and control of stereochemical integrity.
Identification & chemistry
| Generic name | Prasterone |
|---|---|
| Molecule type | Small molecule |
| CAS | 53-43-0 |
| UNII | 459AG36T1B |
| DrugBank ID | DB01708 |
Pharmacology
| Summary | DHEA functions as a steroidogenic prohormone that is converted to androgens and estrogens through CYP‑dependent pathways, with circulating DHEAS serving as a stable reservoir. Its pharmacodynamic activity reflects interactions with multiple nuclear and membrane receptors, including androgen and estrogen receptors, GABA(A) and NMDA receptors, and PPAR‑α. These actions position DHEA as a modulator of endocrine, neuroactive, and metabolic signaling rather than a receptor‑selective agent. |
|---|---|
| Mechanism of action | DHEA can be understood as a prohormone for the sex steroids. DHEAS may be viewed as buffer and reservoir. As most DHEA is produced by the zona reticularis of the adrenal cortex, it is argued that there is a role in the immune and stress response. DHEAS/DHEA are useful to detect excess adrenal activity as seen in adrenal cancer or hyperplasia, including certain forms of congenital adrenal hyperplasia as it is produced nearly entirely by the adrenal glands. Women with polycystic ovary syndrome tend to have elevated levels of DHEAS. |
| Pharmacodynamics | DHEA is naturally produced from cholesterol through two cytochrome P450 enzymes. Cholesterol is converted to pregnenolone by the enzyme P450 scc (side chain cleavage); then another enzyme, CYP17A1, converts pregnenolone to 17α-Hydroxypregnenolone and then to DHEA. DHEA is increased by exercise and calorie restriction. Some theorize that the increase in endogenous DHEA brought about by calorie restriction is partially responsible for the longer life expectancy known to be associated with calorie restriction. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Estrogen receptor alpha | Humans | binder |
| Estrogen receptor beta | Humans | activator |
| GABA(A) Receptor | Humans | antagonist |
ADME / PK
| Absorption | Following a 50-mg DHEA PO dose in cynomolgus monkeys, systemic availability was only 3.1 +/- 0.4%. [PMID: 12970301] |
|---|---|
| Half-life | 12 hours |
| Metabolism | Hepatic. As shown by their high conversion ratios (in a study involving cynomolgus monkeys), the major circulating metabolites of DHEA are DHEA-S, androsterone glucuronide, and androstane-3 alpha,17 beta-diol-glucuronide. [PMID: 12970301] |
Formulation & handling
- Suitable for oral and vaginal delivery, with its lipophilic steroid structure favoring formulations that enhance dissolution or local mucosal absorption.
- Low aqueous solubility may require lipidic, micronized, or solubilizing excipients for consistent oral bioavailability.
- Solid-state steroid with good intrinsic stability, generally compatible with standard handling conditions for non‑peptidic small molecules.
Regulatory status
| Lifecycle | The active ingredient is still under U.S. patent protection, with key expiries occurring in 2028 and a later expiry in 2031, indicating a market that remains partially protected. Across the EU, US, and Canada, overall market maturity will increase as the 2028 patents lapse, with full generic exposure expected after 2031 in the United States. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Prasterone is supplied primarily by a single originator entity associated with the Intrarosa brand, which is marketed in the US, EU, and Canada. Its patents extend in the United States through 2028–2031, supporting ongoing branded exclusivity in that market. These timelines indicate that generic competition is limited at present but may emerge as key protections expire. |
|---|
Safety
| Toxicity | Acute oral toxicity (LD50): >10000 mg/kg [Rat]. Lowest Published Toxic Dose (TDL) [Man] - Route: Oral; Dose: 10 mg/kg/2W intermittent. |
|---|
- Acute oral toxicity is low (rat LD50 ›10000 mg/kg), but intermittent human exposure data report a published toxic dose near 10 mg/kg, indicating potential for dose‑dependent systemic effects under repeated intake conditions
- Endocrine activity may present occupational considerations
- Avoid inhalation or dermal contact that could contribute to unintended hormonal exposure during handling
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Dehydroepiandrosterone 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.
Dehydroepiandrosterone (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.
Dehydroepiandrosterone API manufacturers & distributors
Compare qualified Dehydroepiandrosterone API suppliers worldwide. We currently have 9 companies offering Dehydroepiandrosterone API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Hubei Danjiangkou Kaitai ... | Producer | China | China | CoA | 3 products |
| Jiangsu Jiaerke | Producer | China | China | CoA, USDMF, WC | 11 products |
| Metapharmaceutical Indust... | Producer | Spain | China | BSE/TSE, CoA, GDP, GMP, MSDS, WC | 21 products |
| Productos Quimicos Natura... | Producer | Mexico | Mexico | CoA, USDMF | 3 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS, USDMF | 157 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP | 50 products |
| Zhejiang Xianju Junye | Producer | China | China | CoA, USDMF | 7 products |
When sending a request, specify which Dehydroepiandrosterone 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 Dehydroepiandrosterone 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.
Frequently asked questions about Dehydroepiandrosterone API
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