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Drospirenone | CAS No: 67392-87-4 | GMP-certified suppliers
A medication that supports prevention of pregnancy while also addressing moderate acne, premenstrual dysphoric disorder, menopausal symptoms, and aiding osteoporosis prevention in appropriate postmenopausal populations.
Therapeutic categories
Adrenal Cortex HormonesAgents causing hyperkalemiaAndrostanesCombination Contraceptives (with Estrogen and derivatives)Contraceptive Agents, FemaleContraceptives, Oral
Generic name
Drospirenone
Molecule type
small molecule
CAS number
67392-87-4
DrugBank ID
DB01395
Approval status
Approved drug
ATC code
G03AA18
Primary indications
- Drospirenone, in combination with ethinyl estradiol or estetrol, is indicated as an oral contraceptive for the prevention of pregnancy
- In addition to its use for contraceptive effects, this combination is used to treat moderate acne vulgaris and the symptoms of premenstrual dysphoric disorder
- The drug has approved indications for combination with estrogens for the treatment of menopause-associated symptoms, such as vasomotor symptoms and vulvovaginal atrophy
- Drospirenone combined with estrogen may also may aid in the prevention of osteoporosis in women who have been post-menopausal for at least a year and are not candidates for other therapies
Product Snapshot
- Oral small‑molecule hormone supplied mainly as film‑coated tablets and kits for combination formulations
- Used in combination products for contraception and for estrogen‑containing regimens addressing acne, premenstrual symptoms, and menopause‑related indications
- Approved and marketed in the US, Canada, and the EU
Clinical Overview
Drospirenone (CAS 67392-87-4) is a synthetic progestin used in combination with ethinyl estradiol or estetrol for oral contraception. It is also included in combined hormonal products for moderate acne vulgaris, premenstrual dysphoric disorder, and menopausal symptom management. When paired with estrogen, it may support prevention of postmenopausal osteoporosis in women who are not candidates for other therapies. Additional clinical use includes formulations incorporating folic acid for supplementation during contraceptive therapy.
Pharmacologically, drospirenone suppresses ovulation through inhibition of follicle stimulating hormone and luteinizing hormone. It also alters cervical mucus and endometrial receptivity, contributing to contraceptive efficacy. As a spironolactone analogue, it demonstrates antiandrogenic and antimineralocorticoid activity. Antiandrogen effects help reduce sebum-related acne and hirsutism through interference with dihydrotestosterone binding and ovarian androgen synthesis. Its antimineralocorticoid properties promote sodium and water excretion and may increase potassium levels.
Absorption and distribution characteristics have been well described in clinical use, and metabolism occurs primarily via CYP3A pathways. Drospirenone is excreted as metabolites in feces and urine. It is a substrate of CYP3A4, making its exposure sensitive to strong inhibitors or inducers of this pathway.
Safety considerations include potential for venous thromboembolism, with reported findings remaining inconsistent across studies. Risk is heightened in smokers and women aged 35 years or older. Hyperkalemia is a relevant concern due to antimineralocorticoid activity, especially in individuals with renal impairment or those receiving potassium-sparing therapies. Cardiovascular, thrombotic, and electrolyte risks require adherence to current labeling and clinical monitoring recommendations.
Common usage contexts include widely known contraceptive brands that combine drospirenone with ethinyl estradiol or estetrol.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of steroidal synthesis pathways, validated impurity characterization, and compliance with GMP and regional regulatory expectations to ensure consistency and suitability for finished dosage formulation.
Pharmacologically, drospirenone suppresses ovulation through inhibition of follicle stimulating hormone and luteinizing hormone. It also alters cervical mucus and endometrial receptivity, contributing to contraceptive efficacy. As a spironolactone analogue, it demonstrates antiandrogenic and antimineralocorticoid activity. Antiandrogen effects help reduce sebum-related acne and hirsutism through interference with dihydrotestosterone binding and ovarian androgen synthesis. Its antimineralocorticoid properties promote sodium and water excretion and may increase potassium levels.
Absorption and distribution characteristics have been well described in clinical use, and metabolism occurs primarily via CYP3A pathways. Drospirenone is excreted as metabolites in feces and urine. It is a substrate of CYP3A4, making its exposure sensitive to strong inhibitors or inducers of this pathway.
Safety considerations include potential for venous thromboembolism, with reported findings remaining inconsistent across studies. Risk is heightened in smokers and women aged 35 years or older. Hyperkalemia is a relevant concern due to antimineralocorticoid activity, especially in individuals with renal impairment or those receiving potassium-sparing therapies. Cardiovascular, thrombotic, and electrolyte risks require adherence to current labeling and clinical monitoring recommendations.
Common usage contexts include widely known contraceptive brands that combine drospirenone with ethinyl estradiol or estetrol.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of steroidal synthesis pathways, validated impurity characterization, and compliance with GMP and regional regulatory expectations to ensure consistency and suitability for finished dosage formulation.
Identification & chemistry
| Generic name | Drospirenone |
|---|---|
| Molecule type | Small molecule |
| CAS | 67392-87-4 |
| UNII | N295J34A25 |
| DrugBank ID | DB01395 |
Pharmacology
| Summary | Drospirenone–ethinyl estradiol combines a progestin analog with an estrogen to suppress pituitary release of FSH and LH, inhibiting ovulation and producing contraceptive effects. The combination also alters cervical mucus and endometrial conditions, reducing the likelihood of fertilization and implantation. Drospirenone contributes anti‑mineralocorticoid and antiandrogen activity through interactions with mineralocorticoid, androgen, and progesterone receptors, supporting effects on acne and other androgen‑responsive conditions. |
|---|---|
| Mechanism of action | Drospirenone and ethinyl estradiol in combination suppress the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH), preventing ovulation. Other changes induced by this drug which may aid in the prevention of pregnancy include alterations in cervical mucus consistency, hindering sperm movement, and lowering the chance of embryo implantation. Drospirenone is an analog of the diuretic spironolactone, which exerts anti-mineralocorticoid activity, blocking aldosterone receptors, which increases sodium and water excretion.Studies in animals have demonstrated that drospirenone administration leads to antiandrogenic activity. This activity helps to oppose the effects of naturally occurring androgens, inhibiting the binding of dihydrotestosterone (DHT) to its receptor, and preventing androgen synthesis in the ovaries, helping to treat acne and hirsutism.Drospirenone may also decrease the level of edema in sebaceous follicle during the second half of the menstrual cycle, when acne often appears. |
| Pharmacodynamics | Drospirenone inhibits the maturation of follicles and inhibits ovulation, preventing pregnancy. It has antiandrogen effects, improving acne and hirsutism. When combined with ethinyl estradiol, it has been shown to have favorable effects on the plasma lipid profile.Due to its similarity to naturally occurring progesterone, drospirenone is thought to be associated with a lower incidence of progesterone contraceptive related adverse effects, such as breast tenderness and mood swings. **A note on venous thromboembolism risk and antimineralcorticoid effects** As with other oral contraceptives, the risk of venous thromboembolism and cardiovascular events may be increased when drospirenone is taken. The risk is especially higher in smokers and women aged 35 and older. Women taking this drug should be advised not to smoke. In addition, drospirenone, due to its antimineralcorticoid effects, may increase the risk of hyperkalemia. Patients at high risk for hyperkalemia should not be administered this drug. Consult the official prescribing information for detailed and updated information on the cardiovascular and other risks associated with drospirenone use. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Mineralocorticoid receptor | Humans | antagonist |
| Androgen receptor | Humans | antagonist |
| Progesterone receptor | Humans | agonist |
ADME / PK
| Absorption | The absolute bioavailability of drospirenone is approximately 76% due to first-pass effects.The maximum plasma concentration of drospirenone occurs within 1 to 2 hours after oral administration and is estimated to range between 60 and 87 ng/mL.A European prescribing monograph for the combination product of estradiol and drospirenone indicates that drospirenone is both completely and rapidly absorbed. It reports a Cmax of 21.9 ng/ml, achieved approximately 1-hour post-administration. The absolute bioavailability is reported to range between 76 to 85%. |
|---|---|
| Half-life | The serum half-life of drospirenone is estimated to be 30 hours.The half-life of drospirenone metabolite excretion in the urine and feces is approximately 40 hours. |
| Protein binding | Drospirenone is about 95% to 97% bound to serum plasma protein, likely to albumin.During in vitro studies, drospirenone was found to bind with low affinity to sex hormone-binding globulin (SHBG).Another reference indicates that drospirenone binds to serum albumin but does not bind to sex hormone-binding globulin (SHBG), nor corticoid binding globulin (CBG). Only 3-5% of the total drospirenone concentration is measured as a free steroid. |
| Metabolism | Drospirenone is heavily metabolized. The two major inactive metabolites identified are the acid form of drospirenone produced by the opening of its lactone ring, known as M11, and the 4,5-dihydro-drospirenone-3-sulfate (M14).Drospirenone also undergoes oxidative metabolism via the hepatic cytochrome enzyme CYP3A4. |
| Route of elimination | Various metabolites of drospirenone are measured in the urine and feces. Drospirenone elimination from the body is almost after 10 days post-administrationwhen negligible amounts of drospirenone are found unchanged in both the urine and feces.Between 38% to 47% of the metabolites are identified as glucuronide and sulfate conjugates in the urine. In the feces, approximately 17% to 20% of identifiable metabolites are found to be excreted as glucuronides and sulfates. |
| Volume of distribution | The volume of distribution of drospirenone is estimated to be 4 L/kg, according to the FDA label for Yaz.Prescribing information from a combination of estradiol and drospirenone estimates the volume of distribution to range from 3.7- 4.2 L/kg. |
| Clearance | Drospirenone is rapidly cleared, typically within 2-3 days of administration of the last active tablet.The rate of clearance of drospirenone calculated in the serum ranges from 1.2-1.5 ml/min/kg, however, this value can vary by up to 25% according to the patient. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support use of solid oral forms with solubilization or dispersion strategies for consistent absorption.
- As a small-molecule steroidal lactone, it is chemically stable in solid state but may require protection from moisture and light during processing and storage.
- Oral formulations should account for minimal food-effect sensitivity while avoiding excipients that could interact with CYP3A-modulating co‑administered agents.
Regulatory status
| Lifecycle | The API shows a mature market presence in the US, Canada, and the EU, with several foundational U.S. patents already expired and one later‑expiring patent extending potential protection to 2031. Overall, the market is transitioning toward post‑exclusivity conditions while retaining some remaining patent coverage. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Drospirenone is supplied primarily by a single originator developer, whose products are marketed in the US, Canada, and the EU in several established branded formulations. Many key patents have already expired, while one later‑expiring patent extends to 2031, creating a mixed landscape of existing generic availability alongside some remaining protections. This supports a mature global presence with ongoing but declining originator exclusivity. |
|---|
Safety
| Toxicity | The oral LD50 of drospirenone in rats is >2000 mg/kg. Overdose information An overdose of drospirenone, like other oral contraceptives, may lead to cause nausea or withdrawal bleeding. For drospirenone in particular, as an analog of spironolactone, may affect the levels of serum sodium and potassium. Their concentrations should be monitored in cases of overdose in addition to monitoring from metabolic acidosis and hyperkalemia, which may also result. |
|---|
High Level Warnings:
- Oral LD50 in rats exceeds 2000 mg/kg, indicating relatively low acute oral toxicity under standard test conditions
- Overexposure may produce endocrine‑related effects such as nausea, withdrawal bleeding, and electrolyte disturbances consistent with its spironolactone‑like activity
- Significant overdose can be associated with shifts in serum sodium and potassium, with potential for metabolic acidosis and hyperkalemia
Drospirenone 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.
Drospirenone (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.
Drospirenone API manufacturers & distributors
Compare qualified Drospirenone API suppliers worldwide. We currently have 10 companies offering Drospirenone 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 |
|---|---|---|---|---|---|
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, KDMF, USDMF | 42 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP, USDMF | 48 products |
| Industriale Chimica | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF | 33 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Quimica Sintetica | Producer | Spain | Spain | CoA, GMP | 51 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Symbiotec Pharma | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 50 products |
| Utopharm (Shanghai) Compa... | Producer | China | China | CoA | 12 products |
| Zhejiang Xianju Junye | Producer | China | China | CEP, CoA, FDA | 7 products |
When sending a request, specify which Drospirenone 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 Drospirenone 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 Drospirenone API
Sourcing
What matters most when sourcing GMP-grade Drospirenone?
When sourcing GMP‑grade Drospirenone, ensure the material complies with US, Canadian, and EU regulatory requirements. Attention to supplier qualification is important because most supply originates from a single developer. The mixed patent landscape, with many expirations but one protection lasting to 2031, requires verification of allowable uses in each market.
Which documents are typically required when sourcing Drospirenone API?
Request the core API documentation set: CoA (10 companies), GMP (7 companies), USDMF (6 companies), CEP (5 companies), FDA (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Drospirenone API?
Known or reported manufacturers for Drospirenone: . Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Drospirenone 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 Drospirenone manufacturers?
Audit reports may be requested for Drospirenone: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Drospirenone API on Pharmaoffer?
Reported supplier count for Drospirenone: 10 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Drospirenone API?
Production countries reported for Drospirenone: India (3 producers), China (2 producers), Spain (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Drospirenone usually hold?
Common certifications for Drospirenone suppliers: CoA (10 companies), GMP (7 companies), USDMF (6 companies), CEP (5 companies), FDA (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Drospirenone (CAS 67392-87-4) used for?
Drospirenone is a synthetic progestin used primarily in combination oral contraceptives to prevent ovulation and support contraceptive efficacy. It is also used in combined hormonal products for moderate acne vulgaris, premenstrual dysphoric disorder, and menopausal symptom management, including support for prevention of postmenopausal osteoporosis when paired with estrogen. Its antiandrogenic and antimineralocorticoid effects contribute to acne reduction and fluid balance regulation.
Which therapeutic class does Drospirenone fall into?
Drospirenone belongs to the following therapeutic categories: Adrenal Cortex Hormones, Agents causing hyperkalemia, Androstanes, Combination Contraceptives (with Estrogen and derivatives), Contraceptive Agents, Female. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Drospirenone mainly prescribed for?
The primary indications for Drospirenone: Drospirenone, in combination with ethinyl estradiol or estetrol, is indicated as an oral contraceptive for the prevention of pregnancy, In addition to its use for contraceptive effects, this combination is used to treat moderate acne vulgaris and the symptoms of premenstrual dysphoric disorder, The drug has approved indications for combination with estrogens for the treatment of menopause-associated symptoms, such as vasomotor symptoms and vulvovaginal atrophy, Drospirenone combined with estrogen may also may aid in the prevention of osteoporosis in women who have been post-menopausal for at least a year and are not candidates for other therapies. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Drospirenone work?
Drospirenone and ethinyl estradiol in combination suppress the release of follicle stimulating hormone (FSH) and luteinizing hormone (LH), preventing ovulation. Other changes induced by this drug which may aid in the prevention of pregnancy include alterations in cervical mucus consistency, hindering sperm movement, and lowering the chance of embryo implantation.
Drospirenone is an analog of the diuretic spironolactone, which exerts anti-mineralocorticoid activity, blocking aldosterone receptors, which increases sodium and water excretion.Studies in animals have demonstrated that Drospirenone administration leads to antiandrogenic activity. This activity helps to oppose the effects of naturally occurring androgens, inhibiting the binding of dihydrotestosterone (DHT) to its receptor, and preventing androgen synthesis in the ovaries, helping to treat acne and hirsutism.Drospirenone may also decrease the level of edema in sebaceous follicle during the second half of the menstrual cycle, when acne often appears.
What should someone know about the safety or toxicity profile of Drospirenone?
Drospirenone has low acute oral toxicity in animal studies, with an oral LD50 in rats above 2000 mg/kg. Its antimineralocorticoid activity can cause electrolyte disturbances, including increased potassium and, in significant overdose, metabolic acidosis or hyperkalemia. Endocrine‑related effects such as nausea or withdrawal bleeding may occur with overexposure. Clinical use also requires attention to established risks of venous thromboembolism and to potassium monitoring in patients with renal impairment or those taking potassium‑sparing agents.
What are important formulation and handling considerations for Drospirenone as an API?
Drospirenone’s low aqueous solubility and moderate lipophilicity favor solid oral formulations that use solubilization or dispersion approaches to support consistent absorption. The API is chemically stable in solid state but should be protected from moisture and light during handling and storage. Excipients should be selected to avoid interactions with agents that influence CYP3A pathways. Food-effect sensitivity is minimal, so major adjustments for fed‑state dosing are generally unnecessary.
Is Drospirenone a small molecule?
Drospirenone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Drospirenone?
Oral Drospirenone is chemically stable in solid state but should be protected from moisture and light during manufacturing and storage. Its low aqueous solubility may require solubilization or dispersion approaches to maintain consistent absorption. Excipients should be selected to avoid interactions with agents that modulate CYP3A.
Regulatory
Where is Drospirenone approved or in use globally?
Drospirenone 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 Drospirenone right now?
Drospirenone is regulated for use in the United States, Canada, and the European Union. Its patent landscape is jurisdiction‑specific and typically involves a mix of original substance or formulation patents and subsequent expirations that allow for generic competition. Regulatory and patent requirements in these regions follow established pathways for active pharmaceutical ingredients.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Drospirenone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Drospirenone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Drospirenone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Drospirenone: 474 verified transactions across 126 suppliers and 99 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Drospirenone?
Market report availability for Drospirenone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
