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Aminosalicylic acid | CAS No: 65-49-6 | GMP-certified suppliers
A medication that treats active tuberculosis by inhibiting bacterial growth, commonly used in combination therapy to enhance efficacy and reduce resistance development.
Therapeutic categories
Primary indications
- For the treatment of tuberculosis
Product Snapshot
- Aminosalicylic acid is available in oral formulations including granules and tablets, with both immediate and delayed release options
- It is primarily indicated for the treatment of tuberculosis
- This API is approved for use in the European Union, Canada, and the United States
Clinical Overview
Pharmacologically, aminosalicylic acid exhibits bacteriostatic activity, inhibiting the multiplication of Mycobacterium tuberculosis without directly destroying the bacteria. Its clinical use is informed by two significant considerations: the rapid formation of an inactive toxic metabolite under acidic conditions and a relatively short serum half-life of approximately one hour for the free acid form. To improve tolerability, the sodium salt form of aminosalicylic acid is commonly employed in clinical settings.
The mechanism of action relies on dual pathways. Firstly, aminosalicylic acid competitively inhibits folic acid synthesis by binding to pteridine synthetase with higher affinity than para-aminobenzoic acid. This inhibition disrupts an essential step in folate biosynthesis, impeding bacterial growth since Mycobacterium tuberculosis cannot utilize exogenous folic acid. Secondly, it may interfere with the synthesis of mycobactin, a siderophore critical for iron acquisition in Mycobacterium tuberculosis, thereby limiting essential nutrient uptake.
Key absorption, distribution, metabolism, and excretion (ADME) parameters highlight a rapid metabolism leading to inactive metabolites and brief systemic persistence, necessitating multiple daily doses when administered orally. Safety and toxicity profiles necessitate monitoring for gastrointestinal disturbances and potential hypersensitivity reactions; however, the sodium salt form tends to be better tolerated than the free acid. No specific carcinogenicity or severe systemic toxicity has been consistently documented in approved therapeutic use.
Aminosalicylic acid is approved globally and categorized among antimycobacterial and anti-infective agents used in tuberculosis treatment regimens. Common usage contexts include multi-drug resistant tuberculosis regimens or cases where first-line agents require augmentation.
For active pharmaceutical ingredient procurement, stringent quality control is essential. Suppliers should provide documentation confirming identity, purity, compliance with pharmacopeial standards, and stability under storage conditions. Selection of the sodium salt form might be preferred due to improved patient tolerability in formulation.
Identification & chemistry
| Generic name | Aminosalicylic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 65-49-6 |
| UNII | 5B2658E0N2 |
| DrugBank ID | DB00233 |
Pharmacology
| Summary | Aminosalicylic acid exerts a bacteriostatic effect against Mycobacterium tuberculosis primarily by inhibiting folic acid synthesis through competitive binding to pteridine synthetase, reducing bacterial growth. It also potentially disrupts mycobactin production, impairing iron uptake necessary for bacterial survival. The compound is used in combination therapy to target active tuberculosis by suppressing bacterial multiplication and delaying resistance development. |
|---|---|
| Mechanism of action | There are two mechanisms responsible for aminosalicylic acid's bacteriostatic action against <i>Mycobacterium tuberculosis</i>. Firstly, aminosalicylic acid inhibits folic acid synthesis (without potentiation with antifolic compounds). The binding of para-aminobenzoic acid to pteridine synthetase acts as the first step in folic acid synthesis. Aminosalicylic acid binds pteridine synthetase with greater affinity than para-aminobenzoic acid, effectively inhibiting the synthesis of folic acid. As bacteria are unable to use external sources of folic acid, cell growth and multiplication slows. Secondly, aminosalicylic acid may inhibit the synthesis of the cell wall component, mycobactin, thus reducing iron uptake by <i>M. tuberculosis</i>. |
| Pharmacodynamics | Aminosalicylic acid is an anti-mycobacterial agent used with other anti-tuberculosis drugs (most often isoniazid) for the treatment of all forms of active tuberculosis due to susceptible strains of tubercle bacilli. The two major considerations in the clinical pharmacology of aminosalicylic acid are the prompt production of a toxic inactive metabolite under acid conditions and the short serum half life of one hour for the free drug. Aminosalicylic acid is bacteriostatic against <i>Mycobacterium tuberculosis</i> (prevents the multiplying of bacteria without destroying them). It also inhibits the onset of bacterial resistance to streptomycin and isoniazid. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Inhibitor of nuclear factor kappa-B kinase subunit alpha | Humans | inhibitor |
| Arachidonate 5-lipoxygenase | Humans | inhibitor |
ADME / PK
| Protein binding | 50-60% |
|---|---|
| Metabolism | Hepatic. |
Formulation & handling
- Aminosalicylic acid is a small molecule oral API typically formulated as tablets or granules, including delayed-release forms.
- It exhibits moderate water solubility and low lipophilicity, supporting oral systemic absorption independent of food intake.
- Stability considerations should focus on maintaining solid-state integrity during storage, with no special food-related handling required.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in the EU, Canada, and the US, with patent protection set to expire within the next 12 to 18 months, indicating a transition toward increased generic competition and market maturity. Post-patent expiry, product availability is expected to expand as additional manufacturers enter these markets. |
|---|
| Markets | EU, Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for aminosalicylic acid includes multiple originator companies, with both pharmaceutical manufacturers and packagers contributing to the supply chain. Branded products such as Granupas, Nemasol Sodium Tab 500mg, and Paser have a global presence across the US, EU, and Canadian markets. The presence of multiple manufacturers and established brands, alongside the product’s market distribution, indicates potential existing or forthcoming generic competition, likely influenced by patent expirations. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=4 gm/kg (orally in mice); LD<sub>50</sub>=3650 mg/kg (orally in rabbits) |
|---|
- Handle with appropriate personal protective equipment to avoid ingestion and minimize exposure
- Avoid inhalation and contact with skin or eyes
- May cause adverse toxicological effects
Aminosalicylic Acid is a type of Aminosalicylates
Aminosalicylates are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various inflammatory bowel diseases (IBDs), including ulcerative colitis and Crohn's disease. These compounds exhibit anti-inflammatory properties that target the gastrointestinal tract, helping to alleviate symptoms and manage these chronic conditions effectively.
Aminosalicylates function by inhibiting the production of inflammatory mediators, such as prostaglandins and leukotrienes, which play a significant role in triggering inflammation in the gut. By reducing the levels of these compounds, aminosalicylates aid in the suppression of inflammation, leading to symptom relief and promoting mucosal healing.
Commonly prescribed aminosalicylates include mesalazine (also known as mesalamine), olsalazine, and sulfasalazine. These medications are available in various formulations, including oral tablets, capsules, and rectal suppositories or enemas. The choice of formulation depends on the severity and location of the disease within the gastrointestinal tract.
The use of aminosalicylates has been shown to effectively induce and maintain remission in patients with IBDs. They are generally well-tolerated, with few reported side effects. However, as with any medication, individuals may experience mild adverse reactions, such as nausea, abdominal discomfort, or headaches.
In conclusion, aminosalicylates are a crucial class of pharmaceutical APIs utilized in the treatment of inflammatory bowel diseases. Their anti-inflammatory properties and targeted action on the gastrointestinal tract make them valuable therapeutic options for managing these chronic conditions. Proper usage of aminosalicylates, as directed by healthcare professionals, can significantly improve the quality of life for individuals living with IBDs.
Aminosalicylic Acid (Aminosalicylates), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Aminosalicylic Acid API manufacturers & distributors
Compare qualified Aminosalicylic Acid API suppliers worldwide. We currently have 1 companies offering Aminosalicylic Acid API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
When sending a request, specify which Aminosalicylic Acid 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.).
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