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Ulipristal | CAS No: 159811-51-5 | GMP-certified suppliers
A medication that provides emergency contraception and alleviates symptoms of uterine fibroids in adult women through selective modulation of progesterone receptors.
Therapeutic categories
Primary indications
- As the product Ella (available in Canada and the US), ulipristal is indicated for use as emergency contraception after unprotected intercourse or possible contraceptive failure when administered within 120 hours (5 days) after unprotected intercourse or a known or suspected contraceptive failure
- As the product Fibristal (available in Canada), ulipristal is indicated for treatment of the signs and symptoms of uterine fibroids in adult women
Product Snapshot
- Ulipristal is formulated as orally administered film-coated tablets
- It is primarily used for emergency contraception and treatment of uterine fibroids
- The product is approved for use in the US, Canada, and the EU
Clinical Overview
Pharmacologically, ulipristal exhibits mixed antagonistic and partial agonistic activity at progesterone receptors, acting selectively and reversibly on tissues such as the uterus, cervix, ovaries, and hypothalamus. This compound modulates the reproductive axis by delaying follicular development and ovulation; administration during the mid-follicular phase reduces estradiol levels and slows follicle growth, while dosing around the luteinizing hormone (LH) surge postpones follicular rupture. Early-luteal administration results in endometrial thinning. Ulipristal also binds to glucocorticoid receptors, but with lower activity and greater tolerability compared to mifepristone.
The primary approved clinical use for ulipristal as emergency contraception involves administration within 120 hours of unprotected intercourse or contraceptive failure to prevent pregnancy. Its mechanism of action remains the subject of ongoing research and debate. The predominant evidence supports inhibition or delay of ovulation through suppression of the LH surge. However, recent studies propose an additional or alternative mechanism whereby ulipristal induces changes in endometrial receptivity that may prevent embryo implantation. This post-fertilization effect is ethically significant and has led to updated prescribing information cautioning against use for pregnancy termination.
For uterine fibroids, ulipristal reduces tumor size by inhibiting cell proliferation and promoting apoptosis within fibroid tissue, addressing symptoms such as heavy menstrual bleeding.
Pharmacokinetic data indicate ulipristal undergoes metabolism primarily via cytochrome P450 enzymes including CYP3A4, with implications for potential drug interactions. Safety considerations emphasize monitoring for hepatic effects and ensuring that ulipristal is not used beyond approved indications.
From an API sourcing perspective, procurement should prioritize stringent quality control to ensure receptor binding specificity and purity, given ulipristal’s receptor-mediated mode of action and the sensitive clinical contexts of its use. Compliance with global regulatory standards, including evidence of consistency in active substance characterization and impurity profiles, is critical for pharmaceutical formulation and regulatory submissions.
Identification & chemistry
| Generic name | Ulipristal |
|---|---|
| Molecule type | Small molecule |
| CAS | 159811-51-5 |
| UNII | 6J5J15Q2X8 |
| DrugBank ID | DB08867 |
Pharmacology
| Summary | Ulipristal is a selective progesterone receptor modulator that exerts its effects by competitively binding to progesterone receptors in reproductive tissues, thereby modulating ovulation and endometrial receptivity. Its primary pharmacodynamic actions include delaying or inhibiting ovulation via suppression of luteinizing hormone surges and altering endometrial conditions to prevent embryo implantation. Additionally, ulipristal reduces uterine fibroid size through antiproliferative and pro-apoptotic effects on fibroid cells. |
|---|---|
| Mechanism of action | The exact mechanism of action of ulipristal has been heavily debated [A18504, A175372, A175375, A175378]. On one hand, the majority of official prescribing information labels, monographs, and prior research studies for ulipristal indicated as an emergency contraceptive suggest that its primary mechanism of action revolves around inhibiting or delaying ovulation by suppressing surges in LH that result in the postponement of follicular rupture [A18504, L5575, F3772]. Conversely, some of the latest investigations pertaining to ulipristal's mechanism of action as an emergency contraceptive propose that it principally elicits its action by preventing embryo implantation, as opposed to preventing ovulation [A175372, A175375, A175378]. Although previous investigations have shown that ulipristal essentially has the ability to prevent ovulation equivalent to placebo (ie. null effect or ability) when administered during LH peaks one to two days before ovulation, the agent still demonstrates a stable and consistently high contraceptive effect of approximately >=80% when used at this time . Subsequently, current studies attempt to investigate how ulipristal could elicit emergency contraception via ovulation prevention under circumstances where ovulation had already clearly been observed [A175372, A175375, A175378]. Endometrial biopsy samples studied from such circumstances in such investigations subsequently show that the administered ulipristal causes endometrial tissue to become inhospitable and unsuitable for embryo implantation where a variety of genes characteristic of receptive, pro-gestational endometrium are downregulated [A175372, A175375, A175378]. Nevertheless, most if not all proposed mechanisms commonly agree that ulipristal ultimately demonstrates its pharmacological effects by binding to human progesterone receptors and prevents natural, endogenous progesterone from occupying such receptors [A18504, L5575, F3772, A175372, A175375, A175378]. Regardless, however, considering current and on-going research into ulipristal's ability to prevent embryo implantation, the notion that the medication can elicit post-fertilization effects potentially raises alerts and/or ethical debates over the use of ulipristal owing to potential abortifacient activity [A18504, A175372, A175375, A175378], which is considered to be on par or equipotent to that of mifepristone . Attention should be drawn to the fact that some prescribing information, however, such as the US FDA label for ulipristal indicated for emergency contraception, has included new supplementary commentary since 2018 that directly warns about ulipristal not being indicated for termination of existing pregnancies and suggesting that ulipristal use may confer alterations to the endometrium that may affect implantation and contribute to efficacy. In the treatment of fibroids, ulipristal has been shown to exert direct actions on fibroids reducing their size through inhibition of cell proliferation and induction of apoptosis. |
| Pharmacodynamics | Ulipristal is a selective, reversible progestin receptor modulator and its tissue targets include the uterus, cervix, ovaries, and hypothalamus. Ulipristal may act as an agonist or antagonist in the presence or absence of progesterone based on the tissue target. If given mid-follicular phase, development of the follicle growth is delayed and estradiol concentrations decrease. If given at the time when luteinizing hormone peaks, follicular rapture is delayed by several days. If given early-luteal phase, a decrease in endometrial thickness can be observed. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Progesterone receptor | Humans | modulator |
| Glucocorticoid receptor | Humans | antagonist |
| Androgen receptor | Humans |
ADME / PK
| Absorption | Tmax, healthy subjects, single oral dose = 60-90 minutes; Cmax, healthy subjects, single oral dose = 176 ± 89 ng/mL; AUC(0-∞), healthy subjects, single oral dose = 556 ± 260 ng·h/mL; |
|---|---|
| Half-life | Mean elimination half-life, single oral dose, healthy subject = 32.4 ± 6.3 hours |
| Protein binding | >94% bound to plasma proteins such as albumin, alpha1-acid glycoprotein, lipoproteins (VLDL, LDL, and HDL- due to its lipophillic nature) |
| Metabolism | Ulipristal is metabolized by CYP3A4 and to a lesser extent by CYP1A2 into mono-demethylated (active) and di-methylated (inactive) metabolites. |
| Clearance | Mean oral clearance, single oral dose, healthy subject (CL/F) = 76.8 ± 64.0L/h |
Formulation & handling
- Ulipristal is a small molecule oral drug available primarily as film-coated tablets.
- Its low water solubility and moderate lipophilicity (logP 4.18) should be considered during formulation development.
- The drug can be administered with or without food, with high-fat meals modestly increasing absorption but not impacting clinical effect.
Regulatory status
| Lifecycle | The API is currently protected by multiple patents in the United States, with expiry dates ranging from early 2029 to mid-2030, indicating a mature development stage in the US market. Its presence in the US, Canada, and EU markets suggests established regulatory approvals and ongoing market activities under patent protection. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The supply landscape for Ulipristal is characterized by a limited number of originator companies maintaining branded products predominantly under the name Ella across the US, Canada, and EU markets. All key patents in the United States are set to expire between early 2029 and mid-2030, indicating that generic competition is likely to emerge following these dates. This timeline suggests that current supply remains largely branded, with potential for increased generic sourcing in the near future. |
|---|
Ulipristal 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.
Ulipristal (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.
Ulipristal API manufacturers & distributors
Compare qualified Ulipristal API suppliers worldwide. We currently have 5 companies offering Ulipristal 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 |
|---|---|---|---|---|---|
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Gedeon Richter | Producer | Hungary | Hungary | CoA, USDMF | 48 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Industriale Chimica | Producer | Italy | Unknown | CoA, USDMF | 33 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001, USDMF | 157 products |
When sending a request, specify which Ulipristal 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.).
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