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Etonogestrel | CAS No: 54048-10-1 | GMP-certified suppliers
A medication that provides long‑acting reversible contraception for women, supporting reliable pregnancy prevention including postpartum use and suitability for breastfeeding patients across key markets.
Therapeutic categories
Primary indications
- Etonogestrel is administered in subdermal implants as long-acting reversible contraception
- It is known to be effective in postpartum insertion including breastfeeding women
- Etonogestrel is part of the long-acting contraceptive implants that prevent pregnancy
Product Snapshot
- Etonogestrel is supplied as a long-acting implantable or insertable hormonal product for subcutaneous, intrauterine, or vaginal delivery
- Its primary use is long-acting reversible contraception
- It is approved in the US and Canada, with some presentations holding investigational status
Clinical Overview
Etonogestrel is used in subdermal implants as long‑acting reversible contraception, including postpartum use in breastfeeding patients. Clinical practice supports effective pregnancy prevention for up to three to five years depending on the specific product and release characteristics.
Its contraceptive activity is mediated through suppression of ovulation. Etonogestrel impairs the mid‑cycle luteinizing hormone surge, increases cervical mucus viscosity to reduce sperm penetration, and induces endometrial changes that reduce the likelihood of implantation. High‑affinity binding to progesterone and estrogen receptors in reproductive tissues, the hypothalamus, and the pituitary alters transcriptional regulation and decreases gonadotropin‑releasing hormone and luteinizing hormone secretion.
In pharmacodynamic studies, daily release from implants is approximately 40 micrograms during early use, declining gradually over time. Clinical trial data report very low contraceptive failure rates during the approved three‑year duration of use. Return of ovulation is typically rapid after implant removal, with most individuals resuming menses within approximately three months.
Etonogestrel is a substrate of CYP3A4 and undergoes oxidative hepatic metabolism. Drug interactions with strong inducers of CYP3A may reduce systemic exposure. Renal elimination pathways have been described, although the parent compound is extensively metabolized prior to excretion.
Safety considerations include irregular bleeding patterns, potential effects on glucose tolerance, and interactions with medications influencing CYP3A activity. The active ingredient is used in marketed contraceptive implants such as those historically produced under Organon or successor companies.
For API procurement, quality-focused sourcing should confirm compliance with pharmacopoeial specifications, validated impurity controls, and reliable assessment of enantiomeric and steroidal profile to support formulation consistency and regulatory submission requirements.
Identification & chemistry
| Generic name | Etonogestrel |
|---|---|
| Molecule type | Small molecule |
| CAS | 54048-10-1 |
| UNII | 304GTH6RNH |
| DrugBank ID | DB00294 |
Pharmacology
| Summary | Etonogestrel is a progestin that binds with high affinity to progesterone receptors in reproductive tissues and the hypothalamic–pituitary axis, altering protein synthesis and suppressing gonadotropin‑releasing hormone and luteinizing hormone. This hormonal suppression inhibits ovulation while also increasing cervical mucus viscosity and modifying endometrial conditions to reduce the likelihood of fertilization and implantation. Its pharmacologic profile supports sustained contraceptive activity when delivered via subdermal implant. |
|---|---|
| Mechanism of action | Etonogestrel binds with high affinity to the progesterone and estrogen receptors in the target organs.From the target organs, they include the female reproductive tract, mammary gland, hypothalamus, and pituitary. Once bound, this drug changes the synthesis of different proteins which in order decreases the level of gonadotropin-releasing hormone and the luteinizing hormone. |
| Pharmacodynamics | Etonogestrel attains its therapeutic effect inhibiting fertility by impairing the release of the luteinizing hormone which is one of the most important reproductive hormones for ovulation. As well, etonogestrel is known to increase the viscosity of the cervical mucus hindering the passage of the spermatozoa and altering the lining in the uterus to prevent the implantation of the fertilized eggs in the endometrium. In clinical trials, etonogestrel was implanted and reported to avoid 100% of pregnancies over a three year period. When the implant was removed, normal periods were reinstalled within 90 days in 91% of the individuals. Fertility was established quickly with 20 reported pregnancies within 3 months of implant removal. The implants of etonogestrel release 40 mcg of etonogestrel daily and they usually provide a continuous contraception effect for 3 years. When the implant is administered, the failure rate is reported to be 0.1%. Some non-contraceptive effects are improved dysmenorrhea.All data of etonogestrel comes from patients between 80-130% of the body mass. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Progesterone receptor | Humans | agonist |
ADME / PK
| Absorption | Vaginal administration of etonogestrel is known to be significantly absorbed through the vaginal epithelium but it does not increase the levels of etonogestrel in the urine. On the other hand, oral administration is absorbed in the GI tract and it goes through the first-pass metabolism. When etonogestrel is administered subdermally it is absorbed rapidly into the bloodstream and it presents a bioavailability of 82%.It is reported that the implant releases around 60 mcg per day in the first 3 months and then decreases steady reaching a concentration of 30 mcg at the end of year 2. |
|---|---|
| Half-life | The elimination half-life of etonogestrel is reported to be of 25 hours which indicates a reversible contraceptive effect. |
| Protein binding | Etonogestrel is highly bound to plasma proteins being mainly albumin followed by sex-hormone binding globulin.The protein bound form of the etonogestrel represents around 96-99% of the administered dose. |
| Metabolism | Etonogestrel is highly metabolized in the liver by the action of the cytochrome isoenzyme 3A4 mainly by the presence of hydroxylation, sulfate conjugation and glucuronide conjugation reactions. |
| Route of elimination | The elimination of etonogestrel and its metabolites is mainly done renally. |
| Volume of distribution | The apparent volume of distribution of etonogestrel is of around 201 L. |
| Clearance | The clearance rate of etonogestrel is reported to be of 7.5 L/h. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity favor incorporation into polymer-based sustained‑release systems for subcutaneous, vaginal, and intrauterine delivery rather than oral formulations.
- Solid, hydrophobic API requires solubilization or dispersion within elastomeric or polymer matrices to achieve controlled hormone release and minimize crystallization.
- Stable small‑molecule steroid generally handled under standard dry conditions, with attention to uniform API distribution during implant or ring fabrication.
Regulatory status
| Lifecycle | Patent protection in the US and Canada remains active through multiple later‑expiring patents, with key exclusivities extending to 2026–2030. The API is therefore still in a protected phase overall, though earlier expirations indicate portions of the market may already show signs of maturation. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Etonogestrel supply is centered on a single originator manufacturer, with several affiliated entities handling packaging for distribution. Branded vaginal ring products are established in the US and Canada, with no indication of broad commercialization beyond these markets. Multiple active US patents extending through 2026–2030 suggest continued protection for key formulations and limited near‑term generic entry. |
|---|
Safety
| Toxicity | The reported LD50 of oral etonogestrel in the rat is reported to be higher than 2000 mg/kg.[MSDS] Overdosage can only happen when more than one implant is inserted. In cases of overdose, removal of the implant is recommended.[FDA label] There aren't reports relating etonogestrel with carcinogenesis, mutagenesis or impaired fertility.[FDA label] |
|---|
- Acute oral toxicity in rodents is low, with an LD50 ›2000 mg/kg, indicating limited hazard under typical handling conditions
- No evidence of carcinogenic, mutagenic, or fertility‑impairing effects has been reported in available studies
- Overexposure scenarios are primarily associated with use‑related situations involving multiple implants rather than intrinsic chemical hazard
Etonogestrel 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.
Etonogestrel (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.
Etonogestrel API manufacturers & distributors
Compare qualified Etonogestrel API suppliers worldwide. We currently have 4 companies offering Etonogestrel API, with manufacturing taking place in 4 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 | Spain | CoA, EDMF/ASMF, GMP, MSDS, USDMF | 106 products |
| Gedeon Richter | Producer | Hungary | Hungary | CoA, GMP, USDMF | 48 products |
| Industriale Chimica | Producer | Italy | Unknown | CoA, USDMF | 33 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
When sending a request, specify which Etonogestrel 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 Etonogestrel 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.
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Regulatory
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