Bromhexine metabolite viii (Ambroxol) API Manufacturers & Suppliers
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Ambroxol | CAS No: 18683-91-5 | GMP-certified suppliers
A medication that facilitates mucus clearance in bronchopulmonary diseases, improving respiratory function by reducing abnormal mucus secretion and easing breathing difficulties.
Therapeutic categories
Primary indications
- Ambroxol is indicated for secretolytic therapy in bronchoplmonary disease with abnormal mucus secretion and transport
- It allows the mucus to be more easily cleared and ease a patient's breathing
Product Snapshot
- Ambroxol is available in multiple formulation types including oral tablets, syrups, solutions, sprays, injections, suppositories, and inhalation forms
- Its primary therapeutic use is in secretolytic therapy for bronchopulmonary diseases characterized by abnormal mucus secretion and impaired mucus transport
- Ambroxol has obtained approval in various regulatory markets and is also listed as investigational in some regions
Clinical Overview
Pharmacologically, Ambroxol belongs to the class of phenylmethylamines and exerts mucolytic effects through multiple mechanisms. It stimulates the synthesis and release of pulmonary surfactant from type II pneumocytes, which reduces mucus adhesion to the bronchial walls. This anti-adhesive effect promotes the transport of mucus and contributes to airway defense by protecting against infection and irritation.
At the molecular level, Ambroxol inhibits nitric oxide (NO)-dependent activation of soluble guanylate cyclase, an enzyme involved in the generation of cyclic guanosine monophosphate (cGMP). This inhibition is believed to suppress excess mucus secretion by reducing phlegm viscosity, thereby improving mucociliary clearance.
Pharmacokinetic details such as absorption, distribution, metabolism, and excretion (ADME) specific to Ambroxol are not detailed here; however, it is recognized as a substrate for cytochrome P450 enzymes, particularly CYP3A4, which may be relevant in co-administration with other agents metabolized by this pathway.
Safety considerations include standard monitoring for tolerability and adverse effects typically associated with mucolytic therapy. Ambroxol is available on global markets under various brand names, notably Mucosolvan, Lasolvan, and Mucoangin, and is used in diverse clinical contexts for managing respiratory conditions involving mucus hypersecretion.
For API sourcing, pharmaceutical manufacturers should ensure strict compliance with purity specifications and regulatory standards. Given Ambroxol’s role as a substrate of CYP3A4, high chemical quality and consistent batch-to-batch reproducibility are critical to avoid variability in clinical performance. Suppliers should provide comprehensive certificates of analysis aligned with pharmacopeial requirements and adhere to Good Manufacturing Practices (GMP) to support regulatory filings and product quality assurance.
Identification & chemistry
| Generic name | Ambroxol |
|---|---|
| Molecule type | Small molecule |
| CAS | 18683-91-5 |
| UNII | 200168S0CL |
| DrugBank ID | DB06742 |
Pharmacology
| Summary | Ambroxol is a mucolytic agent indicated for bronchopulmonary diseases characterized by abnormal mucus secretion and impaired clearance. It inhibits nitric oxide-dependent activation of soluble guanylate cyclase, which may reduce excessive mucus secretion. This action decreases mucus viscosity and enhances mucociliary transport in the airways. |
|---|---|
| Mechanism of action | Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions. |
ADME / PK
| Absorption | Rapid and almost complete. |
|---|---|
| Half-life | 7-12 hours |
| Protein binding | Approximately 90% |
Formulation & handling
- Ambroxol is a small molecule compound formulated primarily for oral administration but also available in injectable and respiratory inhalation forms.
- Due to low water solubility (approximately 0.0185 g/L) and moderate lipophilicity (LogP 2.65), formulation strategies should address solubility enhancement for solution preparations.
- Handling considerations should include protection from moisture and proper storage to maintain stability in solid and solution dosage forms.
Regulatory status
Ambroxol is a type of Mucolytics
Mucolytics are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of respiratory conditions. Mucolytics are specifically designed to alleviate respiratory distress by enhancing the clearance of mucus from the airways.
These APIs work by breaking down the chemical bonds within mucus, reducing its viscosity and promoting its removal from the respiratory tract. By thinning the mucus, mucolytics facilitate easier expectoration and help to relieve congestion and cough associated with respiratory conditions such as chronic bronchitis, asthma, and cystic fibrosis.
One of the commonly used mucolytics is N-acetylcysteine (NAC), which acts as a precursor for the synthesis of glutathione—a powerful antioxidant. Glutathione helps to protect the respiratory system from oxidative stress and inflammation, promoting healthy lung function. NAC's mucolytic properties make it an effective treatment for conditions characterized by excessive mucus production.
Mucolytics can be formulated in various dosage forms, including oral tablets, effervescent granules, and inhalation solutions. The choice of formulation depends on the target condition and the desired mode of administration.
Overall, mucolytics play a crucial role in the management of respiratory disorders by improving mucus clearance and reducing airway obstruction. These pharmaceutical APIs offer relief to patients suffering from respiratory conditions, promoting better breathing and overall quality of life.
Ambroxol (Mucolytics), 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.
Ambroxol API manufacturers & distributors
Compare qualified Ambroxol API suppliers worldwide. We currently have 19 companies offering Ambroxol API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Aarambh Life Science | Producer | India | India | CoA, GMP | 19 products |
| Alchymars ICM SM | Producer | India | India | CoA, WC | 8 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, HALAL, ISO14001, ISO9001, Kosher, MSDS | 250 products |
| Bidachem | Producer | Italy | Italy | CEP, CoA, FDA, GMP, KDMF | 14 products |
| Boehringer Ingelheim | Producer | Germany | Germany | CoA, GMP | 35 products |
| Cambrex | Producer | Italy | Unknown | CoA, JDMF | 104 products |
| Darshan Pharmachem (P) Li... | Producer | India | India | CoA, GMP, ISO14001, ISO9001, MSDS, WHO-GMP | 5 products |
| Dong Wha Pharm | Producer | South Korea | South Korea | CoA, JDMF | 4 products |
| Emeishan Hongsen Biopharm... | Producer | China | China | CoA, MSDS | 107 products |
| Erregierre | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 44 products |
| Pen Tsao Chemical Industr... | Producer | Germany | China | CoA, KDMF | 18 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, WC | 54 products |
| Shizuoka Coffein Co | Producer | Japan | Japan | CoA, JDMF | 8 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Ven Petrochem & Pharma | Producer | India | India | CEP, CoA, WC | 3 products |
When sending a request, specify which Ambroxol 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 Ambroxol 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.
