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Acetylcysteine | CAS No: 616-91-1 | GMP-certified suppliers
A medication that supports respiratory care by reducing thick mucus and provides essential treatment for acetaminophen overdose in key markets such as the US and Canada.
Therapeutic categories
Primary indications
- Acetylcysteine is indicated for mucolytic therapy and in the management of [acetaminophen] overdose
Product Snapshot
- Acetylcysteine is a small‑molecule API available in oral, inhalation, and parenteral formulations
- It is used for mucolytic applications and for management of acetaminophen toxicity
- It is approved in the US and Canada, with some investigational listings in additional markets
Clinical Overview
The pharmacologic activity in mucolytic therapy arises from reactive sulfhydryl groups that cleave disulfide bonds within mucin glycoproteins. This reduces the size and viscosity of mucin oligomers, improving clearance. Acetylcysteine may also modulate mucin production through antioxidant effects that influence intracellular redox pathways and downstream signaling involved in MUC5AC transcription. Additional antioxidant activity results from deacetylation to cysteine, supporting endogenous glutathione synthesis.
In acetaminophen toxicity, acetylcysteine replenishes glutathione and can directly conjugate the reactive metabolite N‑acetyl‑p‑benzoquinone imine. This prevents accumulation of protein‑bound adducts in hepatocytes that drive necrosis. Timely administration is essential to limit progression of hepatic injury.
Pharmacodynamic characteristics include a short duration of action with dosing intervals that vary by route of administration. The therapeutic window is wide. Key safety considerations include risk of hypersensitivity reactions, gastrointestinal intolerance, and upper gastrointestinal hemorrhage. Taste and odor can affect adherence, and dilution of oral solutions is sometimes used to improve tolerability.
Pharmacokinetic behavior is route dependent. Systemic exposure varies between oral, inhaled, and intravenous administration because of differences in absorption and first‑pass metabolism. The compound is deacetylated to cysteine and undergoes further metabolic pathways before renal elimination.
Acetylcysteine is available in multiple branded and generic products for inhalation, oral, and intravenous use, depending on regional regulatory approvals and clinical context.
For API procurement, sourcing should prioritize verified identity, control of sulfur‑containing impurities, and compliance with pharmacopeial specifications to ensure suitability for sterile or nonsterile finished dosage forms.
Identification & chemistry
| Generic name | Acetylcysteine |
|---|---|
| Molecule type | Small molecule |
| CAS | 616-91-1 |
| UNII | WYQ7N0BPYC |
| DrugBank ID | DB06151 |
Pharmacology
| Summary | Acetylcysteine reduces mucus viscosity by cleaving disulfide bonds in mucin and modulating mucin production through redox‑dependent effects on signaling pathways. It also serves as a cysteine donor for glutathione synthesis, supporting antioxidant defense. In acetaminophen overdose, it conjugates NAPQI directly or replenishes glutathione to facilitate detoxification. |
|---|---|
| Mechanism of action | A number of possible mechanisms for the mucolytic activity of acetylcysteine have been proposed. Acetylcysteine's sulfhydryl groups may hydrolize disulfide bonds within mucin, breaking down the oligomers, and making the mucin less viscous.Acetylcysteine has also been shown to reduce mucin secretion in rat models.It is an antioxidant in its own right but is also deacetylated to cysteine, which participates in the synthesis of the antioxidant glutathione.The antioxidant activity may also alter intracellular redox reactions, decreasing phosphorylation of EGFR and MAPK, which decrease transcription of the gene MUC5AC which produces mucin. In the case of acetaminophen overdoses, a portion of the drug is metabolized by CYP2E1 to form the potentially toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI).The amount of NAPQI produced in an overdose saturates and depletes glutathione stores.The free NAPQI promiscuously binds to proteins in hepatocytes, leading to cellular necrosis.Acetylcysteine can directly conjugate NAPQI or provide cysteine for glutathione production and NAPQI conjugation. |
| Pharmacodynamics | Acetylcysteine is indicated for mucolytic therapy and in the management of acetaminophen overdose.It has a short duration of action as it is given every 1-8 hours depending on route of administration, and has a wide therapeutic window.Patients should be counselled regarding diluting oral solutions in cola for taste masking,the risk of hypersensitivity, and the risk of upper gastrointestinal hemorrhage. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glutathione synthetase | Humans | stimulator |
| Cystine/glutamate transporter | Humans | activator |
| NAPQI (N-acetyl-p-benzoquinone imine) | Humans | reducer |
ADME / PK
| Absorption | An 11 g dose in the form of an effervescent tablet for solution reaches a mean C<sub>max</sub> of 26.5 µg/mL, with a T<sub>max</sub> of 2 hours, and an AUC of 186 µg\*h/mL. |
|---|---|
| Half-life | The mean terminal half life of acetylcysteine in adults is 5.6 hoursand in pre-term neonates is 11 hours. |
| Protein binding | Acetylcysteine is 66-97% protein bound in serum,usually to albumin. |
| Metabolism | Acetylcysteine can be deacetylated by aminoacylase 1 or other undefined deacetylases before undergoing the normal metabolism of cysteine. |
| Route of elimination | An oral dose of radiolabelled acetylcysteine is 13-38% recovered in the urine in the first 24 hours,while 3% is recovered in the feces. |
| Volume of distribution | The volume of distribution of acetylcysteine is 0.47 L/kg. |
| Clearance | Acetylcysteine has a mean clearance of 0.11 L/hr/kg. |
Formulation & handling
- Highly water‑soluble small molecule suitable for oral, inhalation, and parenteral solutions, with effervescent and soluble tablets leveraging its good aqueous dispersibility.
- Oxidation‑prone thiol requires protection from air and metal ions during processing and storage, with solutions typically stabilized by controlled pH.
- IV and inhalation formulations benefit from antioxidant controls and compatible container–closure systems to prevent discoloration and sulfide odor formation.
Regulatory status
| Lifecycle | The API remains in a protected phase in the US and Canada due to multiple patents extending through 2032, with some earlier protections expiring between 2025 and 2026. Overall, the market is transitioning gradually, with full generic exposure unlikely until the later-expiring patents lapse. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Multiple originator and packager companies participate in the manufacturing and distribution of acetylcysteine, indicating a well‑established and diversified supply base. Branded products are marketed primarily in the United States and Canada, reflecting a concentrated but stable regional presence. Several active US patents extend into the mid‑2020s and early 2030s, suggesting that while some competition may already exist for older formulations, later‑expiring patents may continue to limit full generic entry for certain presentations. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with vomiting, nausea, bronchospasm, periorbital angioedema, and hypotension.Treat patients with symptomatic and supportive measures.Hemodialysis may remove some acetylcysteine from circulation as it is somewhat protein bound. |
|---|
- Overexposure is associated with gastrointestinal distress and hypersensitivity‑type reactions, including bronchospasm and localized angioedema
- High systemic levels may produce cardiovascular depression, such as hypotension
- Compound shows partial plasma protein binding
Acetylcysteine 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.
Acetylcysteine (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.
Acetylcysteine API manufacturers & distributors
Compare qualified Acetylcysteine API suppliers worldwide. We currently have 14 companies offering Acetylcysteine API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Arevipharma | Producer | Germany | Unknown | CEP, CoA, FDA | 25 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Innovative Healthcare | Producer | India | India | CoA, GMP, HALAL, ISO9001, MSDS, WHO-GMP | 10 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| Nippon Protein | Producer | Japan | Japan | CEP, CoA, FDA | 3 products |
| Shanxi Yanghe Pharmaceuti... | Producer | China | China | CoA, FDA, GMP, ISO9001, USDMF, WC | 4 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 767 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Wuhan Grand Hoyo | Producer | China | China | CEP, CoA, GMP, KDMF | 2 products |
When sending a request, specify which Acetylcysteine 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 Acetylcysteine 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.
Frequently asked questions about Acetylcysteine API
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Technical
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Regulatory
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