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Urea | CAS No: 57-13-6 | GMP-certified suppliers
A medication that supports debridement and healing in hyperkeratotic skin and nail conditions, helping manage dry, rough skin disorders including dermatitis, psoriasis, eczema, and calluses.
Therapeutic categories
Primary indications
- Urea is used topically for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar
- Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails
Product Snapshot
- Urea is supplied mainly as a topical dermatologic formulation with limited oral presentations
- It is used for debridement and for managing hyperkeratotic conditions including dry skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, corns, calluses, and damaged or ingrown nails
- It is approved in the US and Canada, with some investigational status in certain applications
Clinical Overview
Topical urea is indicated for debridement and to support healing of hyperkeratotic lesions, particularly when local infection, necrotic tissue, fibrinous debris, or eschar impede recovery. It is used in dry or rough skin disorders, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, calluses, and damaged or ingrown nails. Concentration ranges vary by therapeutic goal, from emollient use to more intensive keratolytic action.
Pharmacodynamically, urea acts as a keratolytic emollient that softens and hydrates the stratum corneum, supporting the removal of thickened or desiccated tissue. It is hygroscopic and enhances water retention within the epidermis, which contributes to improved barrier flexibility. Its keratolytic effect facilitates desquamation in conditions marked by abnormal keratin accumulation. A specific molecular mechanism has not been formally defined.
Systemic absorption from intact skin is minimal, and absorbed urea follows endogenous distribution and renal elimination pathways. When used topically as directed, systemic pharmacokinetic impact is negligible.
Safety considerations primarily relate to local effects. Transient stinging, irritation, or erythema may occur, especially on compromised skin or at higher concentrations. Urea should be used cautiously on extensively broken skin due to the potential for increased penetration and irritation. Serious systemic toxicity is unlikely with topical use.
Urea is widely incorporated in dermatological preparations, with strengths and dosage forms varying across markets. For API procurement, manufacturers should verify identity, purity, particle size as needed for formulation performance, and compliance with relevant pharmacopoeial specifications to ensure consistent quality and suitability for regulated product development.
Identification & chemistry
| Generic name | Urea |
|---|---|
| Molecule type | Small molecule |
| CAS | 57-13-6 |
| UNII | 8W8T17847W |
| DrugBank ID | DB03904 |
Pharmacology
| Summary | Urea acts as a keratolytic and hygroscopic agent that softens and loosens hyperkeratotic tissue while increasing stratum corneum hydration. Its activity facilitates debridement and supports restoration of normal epidermal barrier function in conditions characterized by excess keratin accumulation. Reported molecular interactions span several enzyme classes, though its primary therapeutic effect arises from nonspecific disruption of keratin structure and enhancement of moisture retention. |
|---|---|
| Pharmacodynamics | Urea is a keratolytic emollient that works to treat or prevent dry, rough, scaly, itchy skin. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dihydrofolate reductase | Gallus gallus | activator |
| Arginase-1 | Humans | |
| Carbonic anhydrase 2 | Humans |
Formulation & handling
- Highly water‑soluble small molecule suitable for aqueous topical formulations, with straightforward incorporation into creams, gels, lotions, and emulsions.
- Solid, hygroscopic nature may require controlled humidity during handling and storage to prevent clumping and ensure uniformity in high‑load formulations.
- Oral forms are feasible due to high solubility and chemical stability, with minimal concern for food effects and no peptide‑related degradation pathways.
Regulatory status
| Lifecycle | Patent‑expiry details were not provided, but the product’s established presence in the US and Canadian markets suggests a mature lifecycle. In the absence of remaining exclusivities, it would generally be positioned in a post‑exclusivity or late‑stage market environment. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Urea is a long‑established, non‑patented dermatologic and diagnostic ingredient with no active originator company; supply is dominated by numerous packagers and secondary manufacturers handling finished formulations. Branded and private‑label products are widely available in the US and Canada, indicating broad market penetration without a single reference brand. Patent expiry is not relevant for this mature API, and the market already reflects full generic competition. |
|---|
Urea is a type of Uric acid lowering agents
Uric acid lowering agents are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) specifically designed to target and reduce elevated levels of uric acid in the body. Uric acid is a byproduct of purine metabolism and is typically excreted through the kidneys. However, when uric acid levels become excessively high, it can lead to a condition known as hyperuricemia, which is associated with gout and other related disorders.
Uric acid lowering agents work by inhibiting the production of uric acid or enhancing its excretion from the body. One commonly used class of drugs in this category is xanthine oxidase inhibitors (XOIs), which inhibit the enzyme xanthine oxidase responsible for converting purines to uric acid. By reducing the activity of xanthine oxidase, XOIs effectively lower uric acid levels.
Another class of drugs used as uric acid lowering agents are uricosurics. Uricosurics work by blocking the reabsorption of uric acid in the kidneys, thereby increasing its elimination through urine. This mechanism helps to lower the concentration of uric acid in the bloodstream.
Uric acid lowering agents play a crucial role in the management of hyperuricemia and related conditions such as gout. By effectively reducing uric acid levels, these pharmaceutical APIs alleviate symptoms associated with elevated uric acid, such as joint pain and inflammation.
It is important to note that the use of uric acid lowering agents should be done under the guidance and supervision of a healthcare professional. Individual patient factors and medical history should be considered when determining the appropriate medication and dosage.
Urea (Uric acid lowering agents), 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.
Urea API manufacturers & distributors
Compare qualified Urea API suppliers worldwide. We currently have 8 companies offering Urea 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 | Germany | CoA, GMP | 42 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| CFL - Chemische Fabrik Le... | Producer | Germany | Germany | CoA, GMP | 2 products |
| DNS Fine Chemicals | Producer | India | India | CoA | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Takasugi Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 1 products |
When sending a request, specify which Urea 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 Urea 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 Urea API
Sourcing
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Technical
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Regulatory
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