Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Balsalazide API Manufacturers & Suppliers
6 verified results
All Balsalazide data. Full access. Full negotiation power
Commercial-scale Suppliers
Employees: >600
All certificates
Employees: 1-5
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Balsalazide | CAS No: 80573-04-2 | GMP-certified suppliers
A medication that treats mildly to moderately active ulcerative colitis by delivering targeted anti-inflammatory effects to the colon with a favorable safety profile for inflammatory bowel disease management.
Therapeutic categories
Primary indications
- For the treatment of mildly to moderately active ulcerative colitis
Product Snapshot
- Balsalazide is an oral small molecule formulation available in capsule and film-coated tablet dosage forms
- It is primarily indicated for the treatment of mildly to moderately active ulcerative colitis
- The product is approved for use in the United States and also has investigational status in other markets
Clinical Overview
Pharmacodynamically, balsalazide delivers the active moiety mesalamine (5-aminosalicylic acid, 5-ASA) directly to the colon. The prodrug remains largely inactive systemically until cleaved by colonic bacterial azoreductases, resulting in equimolar release of mesalamine and inert 4-aminobenzoyl-β-alanine. Mesalamine exerts localized anti-inflammatory effects in the intestinal mucosa, primarily by modulating the inflammatory cascade associated with ulcerative colitis.
The exact mechanism of action of mesalamine is not fully elucidated but is thought to involve inhibition of both cyclooxygenase and lipoxygenase pathways. These enzymatic pathways generate arachidonic acid metabolites such as prostaglandins and leukotrienes, which are elevated in chronic intestinal inflammation. By blocking the production of these mediators, mesalamine reduces mucosal inflammation without significant systemic immunosuppression.
Absorption of balsalazide from the upper gastrointestinal tract is minimal, optimizing delivery to the colon. Metabolism is restricted to microbial cleavage in the large intestine. Systemic exposure to mesalamine following balsalazide administration is low, contributing to its targeted effect and safety profile. However, potential adverse effects include nephrotoxicity and hypersensitivity reactions, necessitating monitoring of renal function during therapy.
From a sourcing and quality control perspective, the procurement of balsalazide active pharmaceutical ingredient (API) requires careful assessment of azo compound purity, stability, and absence of residual solvents to ensure pharmaceutical-grade quality. Manufacturers should verify compliance with pharmacopeial standards and control of potential impurities associated with azobenzene derivatives to support safe formulation and regulatory approval.
Identification & chemistry
| Generic name | Balsalazide |
|---|---|
| Molecule type | Small molecule |
| CAS | 80573-04-2 |
| UNII | P80AL8J7ZP |
| DrugBank ID | DB01014 |
Pharmacology
| Summary | Balsalazide is a prodrug that is enzymatically cleaved in the colon to release mesalamine (5-aminosalicylic acid), which exerts local anti-inflammatory effects in the gastrointestinal tract. Its mechanism involves inhibition of cyclooxygenase (Prostaglandin G/H synthase 1 and 2) and lipoxygenase (Arachidonate 5-lipoxygenase) pathways, reducing the production of pro-inflammatory arachidonic acid metabolites. The drug targets include peroxisome proliferator-activated receptor gamma and enzymes involved in eicosanoid synthesis, addressing inflammation associated with mildly to moderately active ulcerative colitis. |
|---|---|
| Mechanism of action | The mechanism of action of 5-aminosalicylic acid is unknown, but appears exert its anti-inflammatory effects locally (in the GI tract) rather than systemically. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways (catalyzes the formation of prostaglandin precursors from arachidonic acid), and through the lipoxygenase pathways (catalyzes the formation of leukotrienes and hydroxyeicosatetraenoic acids from arachidonic acid and its metabolites), is increased in patients with chronic inflammatory bowel disease. Therefore, it is possible that 5-aminosalicylic acid diminishes inflammation by blocking production of arachidonic acid metabolites in the colon through both the inhibition of cyclooxygenase and lipoxygenase. |
| Pharmacodynamics | Balsalazide is a prodrug that has little or no pharmacologic activity until it is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid), an anti inflammatory drug indicated for the treatment of mildly to moderately active ulcerative colitis. Balsalazide disodium is delivered intact to the colon where it is cleaved by bacterial azoreduction to release equimolar quantities of mesalamine, which is the therapeutically active portion of the molecule, and the intert 4-aminobenzoyl-(beta)-alanine. As a result, the spectrum of pharmacologic activity of balsalazide is similar to that of mesalamine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Peroxisome proliferator-activated receptor gamma | Humans | agonist |
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Low and variable, intact balsalazide is poorly absorbed systemically. |
|---|---|
| Half-life | Half-life could not be determined. |
| Protein binding | ≥99% |
| Metabolism | Cleaved in the colon via bacterial azoreduction to 5–aminosalicylic acid (5–ASA) and 4–aminobenzoyl-beta-alanine, the inactive carrier moiety. |
| Route of elimination | The products of the azoreduction of this compound, 5-ASA and 4-aminobenzoyl-ß-alanine, and their N-acetylated metabolites have been identified in plasma, urine and feces. Following single-dose administration of 2.25 g COLAZAL (three 750 mg capsules) under fasting conditions in healthy subjects, mean urinary recovery of balsalazide, 5-ASA, and N-Ac-5-ASA was 0.20%, 0.22% and 10.2%, respectively. |
Formulation & handling
- Balsalazide is a small molecule oral agent primarily formulated as capsules and film-coated tablets.
- It exhibits low water solubility and moderate lipophilicity (LogP 3.17), which may influence formulation strategies for bioavailability.
- The API is stable for oral administration with no significant food interaction, allowing dosing with or without food.
Regulatory status
| Lifecycle | The API is currently marketed in the United States with several patents expiring between 2026 and 2031, indicating ongoing market protection and a moderate stage of lifecycle maturity. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for Balsalazide involves multiple manufacturers and packagers, indicating a diversified production base primarily focused on the US market. The presence of several branded products reflects established originator companies. Patent expirations ranging from 2026 to 2031 suggest ongoing and potential future generic competition in the US market. |
|---|
Safety
| Toxicity | A single oral dose of balsalazide disodium at 5 grams/kg or 4-aminobenzoyl-(beta)-alanine, a metabolite of balsalazide disodium, at 1 gram/kg was non-lethal in mice and rats. No symptoms of acute toxicity were seen at these doses. |
|---|
- Handle balsalazide disodium with standard laboratory safety procedures to minimize exposure
- Avoid inhalation and skin contact during API handling due to limited acute toxicity data
- Use appropriate personal protective equipment to prevent contamination and ensure safe handling
Balsalazide 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.
Balsalazide (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.
Balsalazide API manufacturers & distributors
Compare qualified Balsalazide API suppliers worldwide. We currently have 6 companies offering Balsalazide API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Chifeng Arker Tech. | Producer | China | China | CoA, WC | 8 products |
| Dr. Sahu's Laboratories | Producer | India | India | CoA, GMP | 70 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| Hubei Biocause | Producer | China | China | CoA, GMP | 12 products |
| PharmaZell | Producer | Germany | Germany, India | BSE/TSE, CoA, EDMF/ASMF, FDA, GDP, GMP, MSDS, USDMF, WC | 31 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
When sending a request, specify which Balsalazide 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 Balsalazide 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.
