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Sulindac | CAS No: 38194-50-2 | GMP-certified suppliers
A medication that provides relief from pain and inflammation associated with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder, and acute gouty arthritis.
Therapeutic categories
Primary indications
- For acute or long-term use in the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis), and acute gouty arthritis
Product Snapshot
- Sulindac is supplied as oral tablets and rectal suppositories for small‑molecule solid‑dose formulations
- It is used for symptomatic management of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder conditions, and acute gouty arthritis
- It is approved in the US and Canada, with both approved and investigational regulatory designations
Clinical Overview
Sulindac functions as a prodrug. Following oral administration, it undergoes hepatic reduction to form an active sulfide metabolite, while an inactive sulfone metabolite is also generated. The sulfide metabolite participates in enterohepatic circulation, which contributes to sustained systemic exposure. This metabolic pathway may influence gastrointestinal tolerability compared with some other nonselective NSAIDs.
Pharmacologically, sulindac provides anti-inflammatory, analgesic, and antipyretic effects. Its clinical activity is attributed primarily to reversible inhibition of cyclooxygenase isoenzymes COX‑1 and COX‑2, resulting in reduced prostaglandin synthesis. Antipyretic activity is associated with hypothalamic action leading to enhanced peripheral vasodilation and heat dissipation. Although the precise molecular determinants of its activity are not fully clarified, its pharmacodynamic profile is consistent with other nonselective NSAIDs.
Absorption occurs after oral dosing, with metabolism predominantly in the liver. The active metabolite reaches measurable systemic concentrations and exhibits high plasma protein binding. Elimination occurs through both biliary and renal routes, reflecting contributions from enterohepatic recycling and renal excretion of metabolites. Pharmacokinetic performance may be altered in hepatic impairment due to its reliance on metabolic activation.
Safety considerations align with the nonselective NSAID class. Clinically relevant risks include gastrointestinal ulceration or bleeding, renal function effects, fluid retention, hypertension, and rare photosensitivity reactions. Sulindac has also been associated with hyperkalemia in susceptible populations. Caution is advised in patients with compromised renal or hepatic function and in those receiving concomitant nephrotoxic or protein‑binding–competitive therapies.
For API procurement, sourcing should prioritize suppliers with demonstrated control of stereochemical integrity, impurity profiles related to sulfinyl and sulfide forms, and robust stability data appropriate for global regulatory submission.
Identification & chemistry
| Generic name | Sulindac |
|---|---|
| Molecule type | Small molecule |
| CAS | 38194-50-2 |
| UNII | 184SNS8VUH |
| DrugBank ID | DB00605 |
Pharmacology
| Summary | Sulindac is a nonsteroidal anti‑inflammatory agent whose activity is primarily attributed to inhibition of COX‑1 and COX‑2, reducing prostaglandin synthesis involved in inflammation, pain, and fever. It may also influence hypothalamic pathways related to thermoregulation and interacts with additional targets such as aldose reductase, MAPK3, PPAR‑δ, and prostaglandin receptors. These combined actions support its use in conditions characterized by inflammatory pain. |
|---|---|
| Mechanism of action | Sulindac's exact mechanism of action is unknown. Its antiinflammatory effects are believed to be due to inhibition of both COX-1 and COX-2 which leads to the inhibition of prostaglandin synthesis. Antipyretic effects may be due to action on the hypothalamus, resulting in an increased peripheral blood flow, vasodilation, and subsequent heat dissipation. |
| Pharmacodynamics | Sulindac is a non-steroidal anti-inflammatory indene derivative, also possessing analgesic and antipyretic activities. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Aldose reductase | Humans | inhibitor |
ADME / PK
| Absorption | Approximately 90% absorbed in humans following oral administration. |
|---|---|
| Half-life | The mean half-life of sulindac is 7.8 hours while the mean half-life of the sulfide metabolite is 16.4 hours. |
| Protein binding | At 1 mcg/ml concentrations, approximately 93% sulindac and 98% of its sulfide metabolite are bound to human serum albumin. |
| Metabolism | Undergoes two major biotransformations: reversible reduction to the sulfide metabolite, and irreversible oxidation to the sulfone metabolite. Sulindac and its sulfide and sulfone metabolites undergo extensive enterohepatic circulation. Available evidence indicates that the biological activity resides with the sulfide metabolite. Side chain hydroxylation and hydration of the double bond also occur. |
| Route of elimination | Sulindac is excreted in rat milk; concentrations in milk were 10 to 20% of those levels in plasma. It is not known if sulindac is excreted in human milk. Approximately 50% of the administered dose of sulindac is excreted in the urine with the conjugated sulfone metabolite accounting for the major portion. Hepatic metabolism is an important elimination pathway. |
| Clearance | * Renal cl=68.12 +/- 27.56 mL/min [NORMAL (19-41 yrs)] |
Formulation & handling
- Low aqueous solubility supports conventional oral solid formulations but may require attention to dissolution performance for consistent exposure.
- As a small‑molecule NSAID, it is suitable for standard tablet processing, with typical sensitivity to gastric irritation influencing co‑formulation with protective excipients.
- Food co‑administration considerations indicate a need to assess the impact of fed‑state conditions on dissolution and GI tolerability during formulation development.
Regulatory status
| Lifecycle | Patent protection for this API has either expired or is approaching expiry, suggesting a mature market environment. In Canada and the US, the product landscape reflects established competition consistent with late‑lifecycle status. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Sulindac originated from a single research‑based developer, with subsequent supply dominated by multiple generic manufacturers that formulate and distribute the active ingredient. Branded products such as Clinoril have been marketed mainly in the US and Canada, while numerous packagers support broad distribution. Patent expiry has long passed, and the presence of many established generic producers indicates mature generic competition. |
|---|
Safety
| Toxicity | Acute oral toxicity (LD<sub>50</sub>) in rats is 264 mg/kg. Cases of overdose have been reported and rarely, deaths have occurred. The following signs and symptoms may be observed following overdose: stupor, coma, diminished urine output and hypotension. |
|---|
- Exhibits moderate acute oral toxicity in rats (LD50 ~264 mg/kg), indicating the need for controlled handling and exposure minimization in manufacturing settings
- Overdose data associate the compound with CNS depression (stupor, coma) and systemic effects such as reduced urine output and hypotension, underscoring the importance of preventing high-level exposure
- Personnel should manage the API to avoid conditions that could lead to significant systemic absorption, given the documented severe outcomes in accidental or excessive exposure
Sulindac is a type of NSAIDs
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) are a widely used subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs). These medications are commonly prescribed for their analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. NSAIDs work by inhibiting the production of certain enzymes called cyclooxygenases (COX), which play a crucial role in the synthesis of prostaglandins, substances that contribute to pain, inflammation, and fever.
These pharmaceutical APIs are available in various formulations, including tablets, capsules, creams, and gels, making them convenient for different administration routes. Some popular examples of NSAIDs include aspirin, ibuprofen, naproxen, and diclofenac.
NSAIDs are commonly used to treat a wide range of conditions such as arthritis, musculoskeletal injuries, dental pain, menstrual pain, and headaches. They are also effective in managing inflammatory conditions like rheumatoid arthritis and ankylosing spondylitis.
While NSAIDs are generally safe and effective when used as directed, they may have side effects. These can include gastrointestinal issues such as stomach ulcers or bleeding, cardiovascular risks, and kidney problems. Therefore, it is essential to follow the recommended dosage and consult with healthcare professionals to ensure proper and safe usage.
In conclusion, NSAIDs are a subcategory of pharmaceutical APIs that offer analgesic, anti-inflammatory, and antipyretic properties. Their versatility and effectiveness in treating various conditions make them widely prescribed medications. However, it is crucial to be aware of potential side effects and consult healthcare providers for appropriate usage.
Sulindac (NSAIDs), 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.
Sulindac API manufacturers & distributors
Compare qualified Sulindac API suppliers worldwide. We currently have 2 companies offering Sulindac 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 |
|---|---|---|---|---|---|
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Piramal Pharma Solutions | Producer | India | India | CoA, USDMF, WC | 44 products |
When sending a request, specify which Sulindac 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 Sulindac 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.
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