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Desogestrel | CAS No: 54024-22-5 | GMP-certified suppliers
A medication that supports reliable pregnancy prevention within combined oral contraceptives for partners needing a progestin component focused on consistent contraceptive performance.
Therapeutic categories
Primary indications
- Oral desogestrel is used in combination with [ethinylestradiol] as a contraceptive agent for the prevention of pregnancy
- [FDA label]
- Desogestrel is part of the combined oral contraceptives that contain a mix of estrogen and progestin which inhibit ovulation
Product Snapshot
- Desogestrel is an oral small‑molecule progestin formulated mainly as film‑coated or coated tablets
- It is used as a contraceptive API in combination oral contraceptive products for pregnancy prevention
- It is approved for use in the US and Canada
Clinical Overview
The primary pharmacological action of desogestrel is suppression of ovulation. Following passive cellular entry, it binds selectively to progesterone receptors and alters transcriptional activity, producing endometrial transformation and inhibition of luteinizing hormone and follicle‑stimulating hormone release. These effects lead to anovulation in most cycles and contribute to contraceptive efficacy. Etonogestrel provides high progestational potency with minimal intrinsic androgenic activity.
Additional pharmacodynamic effects include increased cervical mucus viscosity, delayed onset of menstruation, increased insulin secretion and resistance, and changes in lipid and fat metabolism. Reported effects on serum lipid fractions are variable across studies, although overall shifts in total cholesterol remain modest.
Desogestrel and its metabolite undergo hepatic metabolism, primarily through oxidative pathways. It is categorized as a substrate of CYP3A isoenzymes, consistent with clinically relevant drug–drug interaction potential when co‑administered with inducers or inhibitors of these pathways. As with other progestins, distribution and elimination characteristics depend on conversion to the active metabolite; detailed kinetic parameters may vary across populations and formulations.
Safety considerations focus on the established association with increased risk of venous thromboembolism, linked to procoagulant changes in blood factors. Metabolic effects such as insulin resistance warrant attention in individuals with underlying glucose intolerance. No significant effect on total cholesterol levels has been consistently demonstrated.
Desogestrel is marketed primarily within combined oral contraceptives; in the United States it is available only in combination with ethinyl estradiol. For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and consistent conversion to the active metabolite to support formulation performance and regulatory compliance.
Identification & chemistry
| Generic name | Desogestrel |
|---|---|
| Molecule type | Small molecule |
| CAS | 54024-22-5 |
| UNII | 81K9V7M3A3 |
| DrugBank ID | DB00304 |
Pharmacology
| Summary | Desogestrel is a progestin that is converted to etonogestrel, which selectively binds the progesterone receptor to modulate gene transcription and exert high progestational activity with minimal androgenic effects. Its pharmacologic action suppresses gonadotropin secretion, leading to inhibition of ovulation, and increases cervical mucus viscosity. Additional metabolic effects include influences on insulin secretion and lipid‑related pathways. |
|---|---|
| Mechanism of action | Desogestrel enters the cell passively and acts by binding selectively to the progesterone receptor and generating low androgenic activity.Its binding produces an effect like a transcription factor and thus, it produces modifications in the mRNA synthesis. The active metabolite of desogestrel, [etonogestrel], presents a combination of high progestational activity with minimal intrinsic androgenicity.[FDA label] |
| Pharmacodynamics | The effects of desogestrel are divided on reproductive including modification of luteinizing hormone and follicle stimulating hormone, declines on the onset of menstruation, and increases the viscosity of the vaginal fluid; and on metabolic that includes increase insulin secretion and resistance, increased lipase activity, and increased fat deposition.The effect of desogestrel on the lipids has been studied extensively and the results are contradictory. Desogestrel main therapeutic effect due to its mechanism of action is known to be related to the inhibition of the ovulation in 97% of the cycles. This effect was proven in clinical trials in non-breastfeeding women from which the Pearl failure rate was reported to be of 0.17 per 100 women-years. This result indicated that desogestrel is more efficient when compared to other progestogen-only pills.All the therapeutic effect is produced by a transformation of the endometrium followed by an inhibition of the ovulation due to the suppression of other hormones. Desogestrel has been widely confirmed to be related to an increase in the risk of venous thromboembolism due to the driven increased in blood coagulation factors, leading to a pronounced prothrombotic state.However, the effects of desogestrel are known to not impact significantly the level of total cholesterol remaining in the range of change of 10% which allows it to be a molecule that presents a favorable lipid profile. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Progesterone receptor | Humans | agonist |
| Estrogen receptor alpha | Humans | agonist |
ADME / PK
| Absorption | After oral administration, desogestrel is rapidly absorbed and it reaches a peak concentration of 2 ng/ml after 1.5 hours. The bioavailability of desogestrel is reported to be in the range of 60-80% and the reported AUC is of 3000 ng.h/ml.Almost all the administered dose is modified to the active metabolite, [etonogestrel]. |
|---|---|
| Half-life | The terminal half-life of desogestrel is determined to be of 30 hours. |
| Protein binding | The main metabolite of desogestrel is mainly found bound to albumin and sex-hormone binding globulin. Around 96-98% of the administered dose of desogestrel is found bound to plasma proteins from which 40-70% is found bound to sex-hormone binding globulin. |
| Metabolism | Desogestrel is rapidly metabolized in the intestinal mucosa and by first-pass hepatic metabolismto form the major metabolite of desogestrel is [etonogestrel] which is the biologically active metabolite.This modification is described by the hydroxylation in C3 of the desogestrel molecule.Later, etonogestrel is metabolized following the normal pathways of steroid metabolism. On the other hand, due to the 11-methylene side chain, desogestrel cannot be metabolized to other progestins. |
| Route of elimination | The elimination of desogestrel is found to be mainly renal corresponding to about 6 times the dose eliminated in the bile.The elimination of desogestrel is only done as the metabolites and not as the unchanged drug and about 85% of the administered dose can be excreted as metabolites after 6-8 days. |
| Volume of distribution | The apparent volume of distribution of desogestrel is of 1.5 L/kg. |
| Clearance | The metabolic clearance rate of desogestrel is reported to be of about 2 ml/min/kg. |
Formulation & handling
- Low‑solubility, lipophilic small‑molecule steroid typically formulated as oral tablets; may require solubility‑enhancing excipients for consistent bioavailability.
- Solid‑state stability supports conventional tablet manufacturing, with attention to moisture control due to poor aqueous solubility.
- High LogP and steroidal structure favor lipid-based or dispersion approaches when optimizing dissolution performance.
Regulatory status
| Lifecycle | Patent protection for the API in the US and Canada appears to be at or near maturity, and market dynamics are consistent with a product transitioning toward (or already in) a post‑patent phase. As patents expire or lose exclusivity, both markets can typically support increasing generic participation. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Desogestrel is supplied in finished form by an originator‑associated packager, with branded products distributed primarily in the US and Canada. The molecule is well established globally as a contraceptive ingredient, and its long‑expired patents have enabled broad generic availability in many markets. This places it in a mature supply environment with multiple potential manufacturers beyond the branded products listed. |
|---|
Safety
| Toxicity | Administration of large quantities of desogestrel has been shown to produce strong hormonal effects but to lack chronic toxicity. The reported LD50 in rats after oral administration of desogestrel is higher than 2000 mg/kg.Overdose hasn't reported serious effects but only symptoms of nausea and withdrawal of bleeding.[FDA label] Most reports haven't linked the administration of desogestrel with the increased risk of breast cancer. The increased risk has been reported to be related to the duration of use. However, several reports indicate a desogestrel-driven increased risk in cervical intra-epithelial neoplasia but the results are still not conclusive.[FDA label] |
|---|
- Acute toxicity is low in animal models, with oral LD50 in rats exceeding 2000 mg/kg, though high exposures can elicit pronounced progestogenic hormonal effects
- Overexposure has primarily produced transient hormonal-related responses such as nausea or withdrawal bleeding, with no documented severe acute toxicities
- Literature notes exploratory signals for increased cervical intra‑epithelial neoplasia incidence with prolonged exposure, while data on breast cancer risk remain generally inconclusive
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Desogestrel is a type of Contraceptives
Contraceptives are a vital subcategory within the pharmaceutical active pharmaceutical ingredient (API) sector. These substances play a crucial role in preventing unwanted pregnancies and providing individuals with reliable birth control options. Contraceptives are designed to interfere with the natural processes of fertilization and implantation, thereby reducing the chances of conception.
APIs used in contraceptives exhibit specific mechanisms of action to ensure effective contraception. These may include inhibiting ovulation, altering cervical mucus consistency, or impeding sperm mobility and viability. By utilizing targeted APIs, contraceptive manufacturers can develop diverse products, including oral contraceptive pills, contraceptive patches, intrauterine devices (IUDs), and contraceptive injections.
The pharmaceutical industry places utmost importance on the quality, safety, and efficacy of contraceptive APIs. Stringent regulations govern their production, ensuring adherence to Good Manufacturing Practices (GMP) and quality control standards. Additionally, pharmaceutical companies invest in comprehensive research and development to enhance contraceptive formulations, minimize side effects, and improve user compliance.
Contraceptives are widely utilized across the globe, offering individuals the ability to make informed choices regarding family planning and reproductive health. With increasing awareness and evolving societal norms, the demand for effective contraceptives continues to grow. Pharmaceutical API manufacturers play a pivotal role in meeting this demand by producing high-quality contraceptive APIs that provide reliable and accessible birth control options to individuals worldwide.
Desogestrel (Contraceptives), classified under Genitourinary Agents
Genitourinary agents are a category of pharmaceutical active ingredients (APIs) that are specifically designed to target and treat disorders related to the genitourinary system. The genitourinary system encompasses the organs and structures involved in the production, storage, and elimination of urine, as well as the reproductive organs.
These APIs play a crucial role in the treatment of various genitourinary conditions, including urinary tract infections (UTIs), erectile dysfunction, urinary incontinence, benign prostatic hyperplasia (BPH), and other related disorders. They exert their therapeutic effects by interacting with specific receptors or enzymes in the genitourinary system, regulating physiological processes, and restoring normal function.
Some commonly used genitourinary agents include alpha-blockers, which relax the smooth muscles in the prostate and bladder neck, improving urine flow in patients with BPH. Additionally, phosphodiesterase type 5 inhibitors (PDE5 inhibitors) are widely prescribed for erectile dysfunction, as they enhance blood flow to the penile tissues, facilitating erection.
These APIs are typically formulated into various dosage forms, such as tablets, capsules, creams, gels, or injections, allowing for convenient administration to patients. The development and production of genitourinary agents involve stringent quality control measures and compliance with regulatory guidelines to ensure safety, efficacy, and consistent product performance.
In summary, genitourinary agents form a crucial category of pharmaceutical APIs used to treat a range of disorders affecting the genitourinary system. Their targeted mechanisms of action and diverse dosage forms make them valuable tools in improving genitourinary health and enhancing patients' quality of life.
Desogestrel API manufacturers & distributors
Compare qualified Desogestrel API suppliers worldwide. We currently have 11 companies offering Desogestrel 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 |
|---|---|---|---|---|---|
| Curia | Producer | United States | Italy | CEP, CoA, EDMF/ASMF, GMP, MSDS | 106 products |
| Euticals | Producer | Italy | Unknown | CoA, USDMF | 48 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP, USDMF | 48 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Industriale Chimica | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 33 products |
| Libbs Farma | Producer | Brazil | Brazil | CEP, CoA, GMP | 3 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Qinhuangdao Zizhu | Producer | China | China | CEP, CoA, FDA | 10 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Symbiotec Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 50 products |
When sending a request, specify which Desogestrel 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 Desogestrel 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 Desogestrel API
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Technical
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Regulatory
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