Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Flunisolide API Manufacturers & Suppliers
4 verified results
All Flunisolide data. Full access. Full negotiation power
Commercial-scale Suppliers
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Flunisolide | CAS No: 3385-03-3 | GMP-certified suppliers
A medication that provides anti-inflammatory and immunosuppressive effects for the maintenance treatment of asthma and relief of allergic rhinitis symptoms.
Therapeutic categories
Primary indications
- For the maintenance treatment of asthma as a prophylactic therapy
Product Snapshot
- Flunisolide is formulated primarily as metered-dose aerosols, sprays, and nasal solutions suitable for respiratory and nasal administration
- It is indicated mainly for prophylactic maintenance treatment in asthma
- Flunisolide products are approved and marketed in the US and Canadian pharmaceutical markets
Clinical Overview
Pharmacodynamically, flunisolide exerts potent anti-inflammatory effects. It is administered via oral metered-dose inhalers for asthma and as an intranasal spray for allergic rhinitis. The drug’s anti-inflammatory action results from activation of glucocorticoid receptors, which regulate the expression of inflammatory mediators. In allergic rhinitis, flunisolide reduces nasal symptoms such as rhinorrhea, congestion, postnasal drip, sneezing, and throat itching, through suppression of local immune responses.
Mechanistically, flunisolide functions as a glucocorticoid receptor agonist. Its effects are mediated by the induction of lipocortins, which inhibit phospholipase A2 activity, thereby reducing the release of arachidonic acid and subsequent biosynthesis of pro-inflammatory prostaglandins and leukotrienes. Additionally, flunisolide suppresses immune activity by decreasing lymphatic function, reducing immunoglobulin and complement levels, causing lymphocytopenia, and interfering with antigen-antibody interactions. Upon systemic absorption, flunisolide binds to plasma transcortin; only the unbound fraction is pharmacologically active.
Key drug categories include adrenal cortex hormones, anti-asthmatic agents, anti-inflammatory agents, corticosteroid receptor agonists, immunosuppressants, and respiratory system agents. Flunisolide is a substrate and inducer of cytochrome P450 CYP3A4 enzymes, which has implications for drug-drug interactions.
Safety considerations note that systemic corticosteroid exposure can lead to immunosuppression, adrenal suppression, and other steroid-related adverse effects, particularly with long-term or high-dose use. Intranasal application generally limits systemic bioavailability but requires monitoring for local side effects such as nasal irritation.
Notable branded products include AeroBid, Nasalide, and Nasarel, which are used globally in formulations targeting airway inflammation.
From an API procurement perspective, sourcing flunisolide requires adherence to stringent quality standards including impurity profiling, residual solvent limits, and polymorphic consistency. Given its classification as a corticosteroid, regulatory compliance encompasses control of starting materials and manufacturing processes to ensure sterility, stability, and batch-to-batch reproducibility. Suppliers must provide comprehensive documentation to support regulatory filings.
Identification & chemistry
| Generic name | Flunisolide |
|---|---|
| Molecule type | Small molecule |
| CAS | 3385-03-3 |
| UNII | 78M02AA8KF |
| DrugBank ID | DB00180 |
Pharmacology
| Summary | Flunisolide is a synthetic corticosteroid that acts as a glucocorticoid receptor agonist, mediating anti-inflammatory effects through the induction of lipocortins and inhibition of arachidonic acid–derived mediators such as prostaglandins and leukotrienes. Its immunosuppressive activity involves modulation of lymphocyte function, reduction of immunoglobulin and complement levels, and interference with antigen-antibody interactions. Flunisolide is used primarily for the maintenance treatment of asthma and allergic rhinitis by reducing inflammatory and allergic responses in the respiratory tract. |
|---|---|
| Mechanism of action | Flunisolide is a glucocorticoid receptor agonist. The antiinflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. The immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding. Flunisolide binds to plasma transcortin, and it becomes active when it is not bound to transcortin. |
| Pharmacodynamics | Flunisolide is a synthetic corticosteroid. It is administered either as an oral metered-dose inhaler for the treatment of asthma or as a nasal spray for treating allergic rhinitis. Corticosteroids are naturally occurring hormones that prevent or suppress inflammation and immune responses. When given as an intranasal spray, flunisolide reduces watery nasal discharge (rhinorrhea), nasal congestion, postnasal drip, sneezing, and itching oat the back of the throat that are common allergic symptoms. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucocorticoid receptor | Humans | agonist |
ADME / PK
| Absorption | Absorbed rapidly |
|---|---|
| Half-life | 1.8 hours |
| Protein binding | Approximately 40% after oral inhalation |
| Metabolism | Primarily hepatic, converted to the S beta-OH metabolite. |
Formulation & handling
- Flunisolide is a small molecule corticosteroid primarily formulated for nasal and respiratory inhalation delivery as sprays, aerosols, and solutions.
- Its low water solubility and moderate lipophilicity (LogP 1.56) require consideration during formulation to ensure adequate bioavailability and stability.
- Packaging and handling should minimize exposure to moisture and air to maintain potency, given its formulation as metered-dose aerosols and sprays.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patent in the United States expired in July 2015, indicating that the market in the US and Canada has reached a mature phase with generic competition potentially available. Continued presence in these markets reflects established usage beyond patent protection. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Flunisolide includes multiple originator companies involved in production and packaging, with a significant presence of branded products such as Aerobid marketed primarily in the US and Canada. The available patent data indicates expiry in 2015, suggesting that generic competition is currently established in the market. The supply chain encompasses both large pharmaceutical manufacturers and specialized packagers to support product distribution in North American markets. |
|---|
Flunisolide 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.
Flunisolide (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.
Flunisolide API manufacturers & distributors
Compare qualified Flunisolide API suppliers worldwide. We currently have 4 companies offering Flunisolide 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
| Farmabios | Producer | Italy | Italy | CoA, GMP, ISO9001, USDMF | 58 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
When sending a request, specify which Flunisolide 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 Flunisolide 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.
