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Halcinonide API Manufacturers & Suppliers
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Halcinonide | CAS No: 3093-35-4 | GMP-certified suppliers
A medication that provides topical relief for inflammatory and pruritic symptoms in corticosteroid-responsive dermatoses, requiring high-quality API for safe dermatological use.
Therapeutic categories
Primary indications
- Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Product Snapshot
- Halcinonide is available as topical formulations including cream, ointment, solution, and liquid
- It is primarily used for the management of corticosteroid-responsive dermatoses characterized by inflammation and pruritus
- The product has approved status in the US and Canada, with some indications investigational or withdrawn
Clinical Overview
The mechanism of action of halcinonide, similar to other topical corticosteroids, involves anti-inflammatory, antipruritic, and vasoconstrictive effects. Although the precise molecular pathways remain incompletely defined, recent research has identified halcinonide as an activator of myelin basic protein (MBP) expression via smoothened receptor activation. This novel finding indicates potential investigational use in multiple sclerosis therapy as an alternative to established corticosteroids like dexamethasone and methylprednisolone.
Pharmacokinetic data specific to halcinonide are limited, but as a topical corticosteroid, systemic absorption is generally low when applied to intact skin. The compound is metabolized primarily by cytochrome P450 enzymes, notably CYP3A4, which warrants consideration of potential drug interactions and metabolic variability. The duration of systemic exposure is expected to be brief due to local application and metabolic clearance.
Safety considerations include adherence to recommended application guidelines to minimize local adverse effects such as skin atrophy, telangiectasia, or irritation. Systemic toxicity is rare but possible with excessive use or application on large body surface areas, broken skin, or under occlusion. Use in pediatric populations and during pregnancy should be carefully evaluated, balancing therapeutic benefit against potential risks.
Halcinonide is marketed under the brand name Halog® by Ranbaxy Laboratories Inc. In comparative efficacy studies, clobetasol propionate, a different potent corticosteroid, has demonstrated superior clinical effectiveness in treating psoriasis relative to halcinonide.
Effective procurement of halcinonide API requires thorough quality control to ensure compliance with pharmacopeial standards. Given its classification as a very potent topical corticosteroid and its metabolism via CYP3A4, sourcing API with verified purity, stability, and absence of contaminants is critical for clinical safety and regulatory compliance.
Identification & chemistry
| Generic name | Halcinonide |
|---|---|
| Molecule type | Small molecule |
| CAS | 3093-35-4 |
| UNII | SI86V6QNEG |
| DrugBank ID | DB06786 |
Pharmacology
| Summary | Halcinonide is a topical corticosteroid indicated for corticosteroid-responsive dermatoses, exerting anti-inflammatory, antipruritic, and vasoconstrictive effects. Its pharmacology involves activation of the smoothened receptor, which has been shown to increase myelin basic protein expression, indicating potential utility in multiple sclerosis therapy. |
|---|---|
| Mechanism of action | The precise mechanism of action of topical corticosteroids is unclear. However they possess anti-inflammatory, antipruritic, and vasoconstrictive actions. New research indicates that halcinonide activates MBP (myelin basic protein) expression via smoothened receptor activation. This finding suggests that halcinonide could be used in the treatment of multiple sclerosis therapy as an alternative to Dexamethasone or Methylprednisolone. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Smoothened homolog | Humans | agonist, activator |
Formulation & handling
- Halcinonide is a small molecule corticosteroid primarily formulated for topical application in creams, ointments, and solutions.
- Its low water solubility and moderate lipophilicity (LogP 3.3) require careful consideration for formulation stability and skin penetration.
- Handle and store halcinonide formulations to maintain integrity, as steroids can be sensitive to light and temperature variations.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient patent expired in the United States in November 2012. The API is currently marketed in mature markets including the US and Canada. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | Halcinonide is marketed primarily in the US and Canadian markets with multiple branded products supplied by a limited number of originator companies. The patent associated with halcinonide, filed in 1992, has expired, indicating the presence of existing generic competition within these regions. The supply landscape includes both original brands and generic formulations catering to the North American market. |
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Safety
| Toxicity | Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. |
|---|
- Systemic absorption may cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression and related metabolic effects
- Risk of increased systemic exposure rises with high-potency formulations, extensive application areas, prolonged use, or occlusive dressings
- Handling requires measures to minimize dermal and mucosal exposure to reduce potential systemic adverse effects
Halcinonide is a type of Corticosteroids
Corticosteroids are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicine. These synthetic drugs mimic the effects of hormones naturally produced by the adrenal glands. Corticosteroids exhibit potent anti-inflammatory and immunosuppressive properties, making them widely used in the treatment of various medical conditions.
The main therapeutic applications of corticosteroids include the management of inflammatory disorders such as asthma, rheumatoid arthritis, and dermatological conditions like eczema and psoriasis. They are also employed in the treatment of allergic reactions, organ transplantations, and certain types of cancer.
Corticosteroids function by inhibiting the production of inflammatory mediators and suppressing immune responses. They act on specific receptors present in cells throughout the body, modulating gene expression and influencing various metabolic processes. These APIs are available in various formulations, including oral tablets, injectables, inhalers, nasal sprays, and topical creams.
It is crucial to note that corticosteroids must be prescribed and used under medical supervision due to their potential side effects, which can include adrenal suppression, osteoporosis, increased susceptibility to infections, and glucose intolerance. The dosage and duration of treatment vary depending on the condition being treated, and physicians carefully monitor patients to minimize any adverse effects.
In summary, corticosteroids are a vital class of pharmaceutical APIs with powerful anti-inflammatory and immunosuppressive properties. They are extensively used in the treatment of diverse medical conditions, providing relief to patients worldwide. However, their usage requires careful consideration and medical supervision to ensure optimal outcomes and minimize potential risks.
Halcinonide (Corticosteroids), classified under Respiratory Tract Agents
Respiratory Tract Agents are a vital category of pharmaceutical APIs (Active Pharmaceutical Ingredients) designed to treat respiratory conditions and diseases. These agents are specifically formulated to target the respiratory system, which includes the lungs, airways, and nasal passages. They play a crucial role in managing various respiratory disorders, such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
Respiratory Tract Agents encompass a wide range of medications, including bronchodilators, corticosteroids, antihistamines, and mucolytics. Bronchodilators are commonly used to relieve airway constriction and facilitate smooth breathing by relaxing the muscles in the airways. Corticosteroids help reduce inflammation in the respiratory system, alleviating symptoms and preventing exacerbations. Antihistamines work by blocking histamine receptors, thus mitigating allergic reactions that often impact the respiratory tract. Mucolytics aid in loosening and thinning mucus, making it easier to expel from the airways.
These APIs are developed through rigorous research and development processes, ensuring their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers rely on advanced technologies and stringent quality control measures to produce high-quality Respiratory Tract Agents. These APIs are subsequently incorporated into various dosage forms, including inhalers, nasal sprays, nebulizers, and oral medications.
Respiratory Tract Agents are essential in the management of respiratory conditions, providing relief from symptoms, improving lung function, and enhancing the overall quality of life for patients. They are prescribed by healthcare professionals and often used in combination therapies to achieve optimal results. As respiratory disorders continue to affect a significant portion of the global population, the development and availability of effective Respiratory Tract Agents play a vital role in addressing these health challenges and improving patient outcomes.
Halcinonide API manufacturers & distributors
Compare qualified Halcinonide API suppliers worldwide. We currently have 4 companies offering Halcinonide 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP, ISO9001, USDMF | 58 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
When sending a request, specify which Halcinonide 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 Halcinonide 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.
