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Acitretin | CAS No: 55079-83-9 | GMP-certified suppliers
A medication that supports treatment of severe adult psoriasis by providing reliable systemic therapy suitable for suppliers serving North American dermatology markets.
Therapeutic categories
Primary indications
- For the treatment of severe psoriasis in adults
Product Snapshot
- Oral small‑molecule retinoid supplied as capsule formulations
- Used for severe psoriasis in adult populations
- Approved in the United States and Canada
Clinical Overview
Acitretin exerts antipsoriatic effects by reducing keratinocyte hyperproliferation and abnormal keratinisation. Although the precise mechanism is not fully defined, the drug is believed to engage nuclear retinoid receptors, including RAR and RXR, which influence gene transcription linked to epidermal maturation. These actions help normalize the skin cell growth cycle and reduce plaque thickness and scaling.
Following oral administration, absorption is enhanced with food intake and is subject to interindividual variability. The drug is extensively bound to plasma proteins and undergoes hepatic metabolism. Reported terminal half-life values for acitretin are generally in the range of several dozen hours; however, re-esterification to etretinate can occur, particularly in the presence of ethanol, leading to a much longer effective elimination period. Excretion occurs through both biliary and renal pathways.
Safety considerations include known teratogenicity, necessitating strict pregnancy prevention measures during treatment and for an extended period after discontinuation. Hepatotoxicity has been documented, and monitoring of liver function and lipid profiles is standard practice. Photosensitivity can occur due to the drug’s interaction with ultraviolet exposure. Use is typically confined to patients with severe, refractory psoriasis who can adhere to the required monitoring protocols. Commonly referenced brand products include Soriatane and Neotigason, depending on regional availability.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of retinoid-specific impurities, validated stability data, and robust photostability protection across the supply chain to ensure consistent quality and regulatory compliance.
Identification & chemistry
| Generic name | Acitretin |
|---|---|
| Molecule type | Small molecule |
| CAS | 55079-83-9 |
| UNII | LCH760E9T7 |
| DrugBank ID | DB00459 |
Pharmacology
| Summary | Acitretin is a systemic retinoid thought to act through binding and modulating retinoid receptors, including RAR and RXR isoforms, which regulate gene transcription involved in skin cell differentiation. Its pharmacologic effect centers on normalizing keratinocyte growth and reducing the hyperproliferation and abnormal keratinization characteristic of severe psoriasis. These actions lead to decreased plaque formation and scaling. |
|---|---|
| Mechanism of action | The mechanism of action of acitretin is unknown, however it is believed to work by targeting specific receptors (retinoid receptors such as RXR and RAR) in the skin which help normalize the growth cycle of skin cells. |
| Pharmacodynamics | Acitretin is a retinoid. Retinoids have a structure similar to vitamin A and are involved in the normal growth of skin cells. Acitretin works by inhibiting the excessive cell growth and keratinisation (process by which skin cells become thickened due to the deposition of a protein within them) seen in psoriasis. It therefore reduces the thickening of the skin, plaque formation and scaling. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Retinoic acid receptor RXR-alpha | Humans | agonist |
| Retinoic acid receptor alpha | Humans | agonist |
| Retinoic acid receptor beta | Humans | agonist |
ADME / PK
| Absorption | Oral absorption of acitretin is optimal when given with food, and is linear and proportional with increasing doses from 25 to 100 mg. Approximately 72% (range 47% to 109%) of the administered dose was absorbed after a single 50 mg dose of acitretin was given to 12 healthy subjects. |
|---|---|
| Half-life | 49 hours (range 33 to 96 hours) |
| Protein binding | Over 99.9% bound to plasma proteins, primarily albumin. |
| Metabolism | Following oral absorption, acitretin undergoes extensive metabolism and interconversion by simple isomerization to its 13-cis form (cis-acitretin). Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. |
| Route of elimination | Both parent compound and isomer are further metabolized into chain-shortened breakdown products and conjugates, which are excreted. The chain-shortened metabolites and conjugates of acitretin and cis-acitretin are ultimately excreted in the feces (34% to 54%) and urine (16% to 53%). |
Formulation & handling
- Oral small‑molecule retinoid with very low aqueous solubility, typically requiring lipid-based or solubilizing excipients for capsule formulations.
- Absorption is food‑dependent, with higher bioavailability when administered with meals, which may guide formulation strategies to enhance uptake.
- Photosensitive and oxidation‑prone retinoid structure necessitates protection from light and oxygen during processing and storage.
Regulatory status
| Lifecycle | The product is marketed in the United States and Canada, with lifecycle status primarily determined by the timing of its core patent and exclusivity expiries. As these protections near or reach expiration, the markets are expected to shift toward a more mature, competitive generic environment. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The listed supply chain shows one primary manufacturer, with several packagers supporting downstream distribution, indicating a relatively centralized originator role with diversified finishing operations. Branded products are present in the US and Canada, reflecting established North American market availability. Acitretin’s long‑expired patent protection suggests that generic competition is already well established. |
|---|
Safety
| Toxicity | Oral, rat: LD<sub>50</sub> = >4000 mg/kg. Symptoms of overdose include headache and vertigo. |
|---|
- High oral safety margin in rats (LD50 ›4000 mg/kg), but overdose exposure has been associated with central nervous system effects such as headache and vertigo
- Implement controls to limit inhalation or accidental ingestion during handling due to potential neurotoxic symptoms at excessive doses
- Standard protective measures recommended for bulk pharmaceutical chemicals with low acute toxicity but identifiable CNS-related adverse effects
Acitretin is a type of Retinoids
Retinoids are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in dermatology and skincare products. Derived from vitamin A, retinoids play a crucial role in promoting skin health and treating various skin conditions. They are popular due to their proven effectiveness in combating acne, reducing wrinkles, and improving overall skin texture.
Retinoids work by binding to specific receptors in the skin cells, influencing gene expression and cellular processes. This action helps regulate the growth and differentiation of skin cells, promoting the turnover of old cells and the production of new, healthier cells. As a result, retinoids can unclog pores, reduce sebum production, and prevent the formation of acne lesions.
Furthermore, retinoids stimulate collagen production, which enhances skin elasticity and reduces the appearance of fine lines and wrinkles. They also possess antioxidant properties, protecting the skin from damage caused by environmental factors such as UV radiation.
Common retinoids used in skincare formulations include retinol, retinaldehyde, and tretinoin (also known as all-trans retinoic acid). These compounds vary in their potency and stability, with tretinoin being the most potent and retinol requiring conversion within the skin to become active.
However, it is important to note that retinoids may cause skin irritation, redness, and dryness, especially during the initial stages of usage. Gradual introduction and proper skincare routines can help minimize these side effects.
In summary, retinoids are a highly sought-after subcategory of pharmaceutical APIs for their significant benefits in skincare. They offer a promising solution for those seeking to improve their skin's health, combat acne, and reduce signs of aging.
Acitretin (Retinoids), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Acitretin API manufacturers & distributors
Compare qualified Acitretin API suppliers worldwide. We currently have 5 companies offering Acitretin API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| BASF | Producer | Germany | Unknown | CEP, CoA, FDA, GMP | 18 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| USV | Producer | India | India | CoA, GMP, USDMF, WC | 35 products |
When sending a request, specify which Acitretin 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 Acitretin 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 Acitretin API
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Technical
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Regulatory
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