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Fenspiride | CAS No: 5053-06-5 | GMP-certified suppliers

A medication that supports treatment of acute and chronic inflammatory respiratory and ENT conditions, including asthma, by improving airway function and managing obstructive airway diseases.

Therapeutic categories

Anti-Asthmatic AgentsAutonomic AgentsBronchodilator AgentsDrugs for Obstructive Airway DiseasesPeripheral Nervous System AgentsRespiratory System Agents
Generic name
Fenspiride
Molecule type
small molecule
CAS number
5053-06-5
DrugBank ID
DB08979
Approval status
Experimental drug
ATC code
R03BX01

Product Snapshot

  • Fenspiride is available in multiple oral formulations including capsules, syrup, and pills, as well as suppositories
  • It is primarily investigated for respiratory conditions with anti-inflammatory and bronchodilator properties
  • The compound remains in experimental status without formal approval from major regulatory agencies

Clinical Overview

Fenspiride (CAS Number 5053-06-5) is an oxazolidinone spiro compound classified within the azaspirodecane derivatives, characterized by a spirodecane structure incorporating nitrogen. It is utilized primarily for the treatment of certain respiratory diseases, with regulatory approval in Russia for acute and chronic inflammatory conditions of the ear, nose, and throat (ENT) organs and the respiratory tract. Indications include rhinopharyngitis, laryngitis, tracheobronchitis, otitis, and sinusitis, along with maintenance therapy in asthma management.

The pharmacological profile of fenspiride positions it within several therapeutic categories: anti-asthmatic agents, bronchodilators, autonomic agents, drugs for obstructive airway diseases, peripheral nervous system agents, and respiratory system agents. However, specific pharmacodynamics and detailed mechanisms of action for fenspiride are not well documented in the publicly available scientific literature. This compound is understood to exert its effects through interactions relevant to respiratory inflammation and airway function, though precise molecular targets remain unspecified.

Key absorption, distribution, metabolism, and excretion (ADME) parameters for fenspiride have not been comprehensively detailed in current data sources. Given its systemic therapeutic use, consideration of metabolic pathways and elimination kinetics would be critical for dosage optimization and safety assessment in clinical contexts.

Safety and toxicity profiles of fenspiride require cautious appraisal due to limited global exposure and clinical data, with use confined largely to specific regional markets. No widespread international regulatory approvals exist at this time. Monitoring for adverse effects related to respiratory and autonomic system modulation is advisable, as is vigilance for off-target reactions.

In sourcing fenspiride API, stringent quality control measures aligning with pharmacopeial standards and regulatory requirements must be enforced. The scarcity of international suppliers and the need for authenticated, reproducible batches underscore the importance of validated manufacturing processes and comprehensive impurity profiling to ensure batch consistency and compliance with regional registration demands.

Identification & chemistry

Generic name Fenspiride
Molecule type Small molecule
CAS 5053-06-5
UNII S983QC7HKM
DrugBank ID DB08979

Formulation & handling

  • Fenspiride is a small molecule suitable for oral administration, available in capsule, syrup, pill, and suppository forms.
  • Moderate water solubility and logP suggest reasonable bioavailability and formulation flexibility.
  • No specific peptide or biologic sensitivities noted; standard handling and stability protocols for small molecules apply.

Regulatory status

Fenspiride is a type of Cough suppressants


Cough suppressants, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), are commonly used to alleviate coughing symptoms. These medications act on the central nervous system to reduce the urge to cough, providing temporary relief and improving patient comfort. Cough suppressants are widely employed in the treatment of various respiratory conditions, including colds, flu, bronchitis, and allergies.

The primary mechanism of action for cough suppressants involves targeting the cough reflex arc. This reflex arc comprises sensory nerve fibers in the respiratory tract that detect irritants, sending signals to the brainstem to initiate coughing. Cough suppressants work by suppressing this reflex at different points, depending on the specific drug.

One widely used class of cough suppressants is opioid derivatives, such as codeine and hydrocodone. These substances act by binding to opioid receptors in the brain, decreasing the sensitivity of the cough reflex. Another class includes non-opioid agents, such as dextromethorphan, which functions by affecting receptors in the brain called NMDA receptors.

Cough suppressants are available in various formulations, including oral syrups, tablets, and capsules. They are often combined with other active ingredients, such as expectorants or antihistamines, to provide a more comprehensive treatment approach.

While cough suppressants can provide symptomatic relief, it is crucial to use them under proper medical guidance. Certain individuals, such as those with respiratory conditions like chronic obstructive pulmonary disease (COPD) or asthma, may require cautious use or alternative treatment options due to potential side effects or drug interactions.

In conclusion, cough suppressants are an essential subcategory of pharmaceutical APIs utilized to manage coughing symptoms. These medications work by targeting the cough reflex arc in the central nervous system, providing temporary relief from coughing. Careful consideration should be given to appropriate usage and potential contraindications, ensuring safe and effective treatment.


Fenspiride (Cough suppressants), 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.