Global API sourcing simplified
We connect API buyers and suppliers worldwide with speed, trust, and full transparency.

Filters

Filters
Filter
Custom request?
Type
Production region
Qualifications
Show more
Country of origin
Show more

Bromhexine metabolite viii (Ambroxol) API Manufacturers & Suppliers

19 verified results
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency Total market transparency
|
Supplier trade data access Supplier trade data access
|
Buyer / supplier flow comparison Buyer / supplier flow comparison

Commercial-scale Suppliers

Producer
Produced in  India
|

Employees: 5000+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
EDMF/ASMF
|
MSDS
|
BSE/TSE

All certificates

GMP
CEP
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
WC
CoA
Distributor
Produced in  India
|

Employees: 10

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
MSDS
|
BSE/TSE
|
CoA

All certificates

GMP
FDA
MSDS
BSE/TSE
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
MSDS
|
BSE/TSE
|
ISO9001

All certificates

GMP
CEP
MSDS
BSE/TSE
ISO9001
CoA
HALAL
Kosher
ISO14001
Producer
Produced in  India
|

Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CoA

All certificates

GMP
FDA
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: MSDS
|
CoA

All certificates

MSDS
CoA
Producer
Produced in  India
|

Employees: 60

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
ISO9001
|
CoA
|
ISO14001

All certificates

GMP
MSDS
ISO9001
CoA
ISO14001
WHO-GMP
Get full market intelligence report
Get full market intelligence report
€399,-
All Ambroxol data. Full access. Full negotiation power
Distributor
Produced in  Singapore
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
EDMF/ASMF

All certificates

GMP
FDA
CEP
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
JDMF
WC
KDMF
CoA
Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
coa

All certificates

GMP
coa
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: WC
|
CoA

All certificates

WC
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: KDMF
|
coa

All certificates

KDMF
coa
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: CEP
|
coa
|
WC

All certificates

CEP
coa
WC
Get full market intelligence report
Get full market intelligence report
€399,-
All Ambroxol data. Full access. Full negotiation power
Producer
Produced in  Japan
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  Italy
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
FDA
|
CEP
|
KDMF
|
coa

All certificates

GMP
FDA
CEP
KDMF
coa
Producer
Produced in  Unknown
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in  Italy
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
coa

All certificates

GMP
FDA
CEP
USDMF
coa
Not active
Producer
Produced in  Germany
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

All certificates

GMP
CoA
Not active
Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Not active
When insight is your advantage
Full data, full access, full negotiation power
Total market transparency Total market transparency
|
Supplier trade data access Supplier trade data access
|
Buyer / supplier flow comparison Buyer / supplier flow comparison
Trusted by 30,000+ registered pharma professionals:
Reach multinationals, SMEs, compounding pharmacies & more!
Procaps
Pfizer
Reckitt
Sanofi
Blau
Abbvie

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

Adrenergics for Systemic UseAminesAnestheticsAnesthetics, LocalAniline CompoundsCough and Cold Preparations
Generic name
Ambroxol
Molecule type
small molecule
CAS number
18683-91-5
DrugBank ID
DB06742
Approval status
Approved drug, Investigational drug
ATC code
R02AD05

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

Ambroxol (CAS number 18683-91-5) is a secretolytic agent primarily indicated for the treatment of respiratory diseases characterized by abnormal mucus secretion and impaired mucus transport, such as bronchopulmonary disorders. It facilitates mucus clearance from the respiratory tract, thereby easing breathing difficulties associated with viscous or excessive mucus.

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

SummaryAmbroxol 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 actionAmbroxol 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

AbsorptionRapid and almost complete.
Half-life7-12 hours
Protein bindingApproximately 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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
India India CoA, GMP19 products
Producer
India India CoA, WC8 products
Distributor
Singapore Singapore BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC200 products
Distributor
China China BSE/TSE, CEP, CoA, GMP, HALAL, ISO14001, ISO9001, Kosher, MSDS250 products
Producer
Italy Italy CEP, CoA, FDA, GMP, KDMF14 products
Producer
Germany Germany CoA, GMP35 products
Producer
Italy Unknown CoA, JDMF104 products
Producer
India India CoA, GMP, ISO14001, ISO9001, MSDS, WHO-GMP5 products
Producer
South Korea South Korea CoA, JDMF4 products
Producer
China China CoA, MSDS107 products
Producer
Italy Italy CEP, CoA, FDA, GMP, USDMF44 products
Producer
Germany China CoA, KDMF18 products
Producer
India India CoA, FDA, GMP515 products
Distributor
China China CoA162 products
Producer
India India BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, WC54 products
Producer
Japan Japan CoA, JDMF8 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, MSDS263 products
Distributor
China China CoA12 products
Producer
India India CEP, CoA, WC3 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.