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Celecoxibum (Celecoxib) API Manufacturers & Suppliers
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Celecoxib | CAS No: 169590-42-5 | GMP-certified suppliers
A medication that provides symptomatic relief in adult osteoarthritis, rheumatoid arthritis, acute pain, juvenile rheumatoid arthritis, ankylosing spondylitis, and primary dysmenorrhea.
Therapeutic categories
Primary indications
- Celecoxib is indicated for symptomatic treatment of adult osteoarthritis (OA) and adult rheumatoid arthritis (RA)
- Celecoxib is not a substitute for aspirin for cardiovascular event prophylaxis
- It may be also be used to treat acute pain from various sources, juvenile rheumatoid arthritis in children over 2, ankylosing spondylitis, and primary dysmenorrhea
Product Snapshot
- Celecoxib is formulated primarily as oral capsules and tablets, with some topical and liquid-filled capsule presentations
- It is mainly indicated for symptomatic treatment of adult osteoarthritis, rheumatoid arthritis, and management of acute pain conditions
- Celecoxib is approved for use in key regulatory markets including the US, Canada, and the EU
Clinical Overview
Pharmacologically, celecoxib selectively inhibits the COX-2 enzyme, which is upregulated in inflamed tissues and responsible for the synthesis of pro-inflammatory prostaglandins such as prostaglandin E2, prostacyclin, and thromboxane. This selective inhibition results in decreased inflammation and pain with a comparatively lower risk of gastrointestinal ulceration and bleeding than nonselective NSAIDs, due to less disruption of gastric mucosal prostaglandin synthesis. However, gastrointestinal risks remain and caution is advised in susceptible patients.
Absorption of celecoxib is oral, with metabolism primarily via cytochrome P450 enzymes CYP2C9 and to a lesser extent CYP3A4. The drug is a substrate and moderate inhibitor of CYP2D6 and has interactions relating to P-glycoprotein and BCRP transporters. Elimination half-life supports once or twice daily dosing.
Safety considerations include a class-associated increased risk of cardiovascular thrombotic events related to the imbalance of pro-aggregatory thromboxane A2 and anti-aggregatory prostacyclin following COX-2 inhibition. Post-marketing studies such as the PRECISION trial demonstrated cardiovascular safety of celecoxib at low doses comparable to naproxen and ibuprofen, but caution is warranted in patients with prior cardiovascular disease, in whom NSAID use is generally discouraged. Other adverse effects include potential for hyperkalemia, hypertension, nephrotoxicity, and photosensitivity.
Celecoxib is marketed globally under the brand name Celebrex, initially approved by the U.S. FDA in 1998. Given its widespread clinical use and complexity of synthesis, API procurement should prioritize suppliers adhering to current Good Manufacturing Practices (cGMP) with assured purity, consistent polymorphic form, and controlled residual solvents. Comprehensive batch analytical documentation and regulatory compliance are essential to support downstream formulation, stability, and regulatory submission.
Identification & chemistry
| Generic name | Celecoxib |
|---|---|
| Molecule type | Small molecule |
| CAS | 169590-42-5 |
| UNII | JCX84Q7J1L |
| DrugBank ID | DB00482 |
Pharmacology
| Summary | Celecoxib is a selective noncompetitive inhibitor of cyclooxygenase-2 (COX-2), reducing the synthesis of pro-inflammatory prostaglandins to alleviate pain and inflammation. It also binds to cadherin-11 and inhibits 3-phosphoinositide-dependent kinase-1 (PDK-1) and carbonic anhydrase enzymes 2 and 3, contributing to its anticancer effects. Its pharmacodynamic profile includes a lower risk of gastrointestinal ulceration compared to nonselective NSAIDs but carries a risk of thrombotic cardiovascular events associated with COX-2 inhibition. |
|---|---|
| Mechanism of action | Unlike most NSAIDs, which inhibit both types of cyclooxygenases (COX-1 and COX-2), celecoxib is a selective noncompetitive inhibitor of cyclooxygenase-2 (COX-2) enzyme. COX-2 is expressed heavily in inflamed tissues where it is induced by inflammatory mediators. The inhibition of this enzyme reduces the synthesis of metabolites that include prostaglandin E2 (PGE2), prostacyclin (PGI2), thromboxane (TXA2), prostaglandin D2 (PGD2), and prostaglandin F2 (PGF2). Resultant inhibition of these mediators leads to the alleviation of pain and inflammation. By inhibiting prostaglandin synthesis, non-steroidal anti-inflammatory drugs (NSAIDs) cause mucosal damage, ulceration and ulcer complication throughout the gastrointestinal tract. Celecoxib poses less of an ulceration risk than other NSAIDS, owing to its decreased effect on gastric mucosal prostaglandin synthesis when compared to placebo. Celecoxib exerts anticancer effects by binding to the cadherin-11 (CDH11)protein, which is thought to be involved in the progression of tumors, and inhibiting the 3-phosphoinositide-dependent kinase-1 (PDK-1) signaling mechanism. In addition, celecoxib has been found to inhibit carbonic anhydrase enzymes 2 and 3, further enhancing its anticancer effects. As mentioned in the pharmacodynamics section of this drug entry, celecoxib may cause an increased risk of thrombotic events. The risk of thrombosis resulting from COX-2 inhibition is caused by the vasoconstricting actions of thromboxane A2, leading to enhanced platelet aggregation, which is uncontrolled when the actions of prostacyclin, a platelet aggregation inhibitor, are suppressed through the inhibition of COX-2. |
| Pharmacodynamics | Celecoxib inhibits cyclooxygenase 2 (COX-2) enzyme, reducing pain and inflammation. It is important to note that though the risk of bleeding with celecoxib is lower than with certain other NSAIDS, it exists nonetheless and caution must be observed when it is administered to those with a high risk of gastrointestinal bleeding. **A note on the risk of cardiovascular events** Significant concerns regarding the safety of COX-2 selective NSAIDs emerged in the early 2000s. [Rofecoxib], another member of the COX-2 inhibitor drug class, also known as Vioxx, was withdrawn from the market due to prothrombotic cardiovascular risks. Following an FDA Advisory Committee meeting in 2005, in which data from large clinical outcome trials were evaluated, the FDA concluded that the risk for cardiovascular thrombotic events for both COX-2 selective NSAIDs and nonselective NSAIDs was evident. It was determined that the benefits of celecoxib treatment, however, outweighed the risks. Postmarketing cardiovascular outcomes trial (PRECISION) revealed that the lowest possible dose of celecoxib was similar in cardiovascular safety to moderate strength doses of both naproxen and ibuprofen. Patients who had previous cardiovascular events including acute MI, coronary revascularization, or coronary stent insertion were not evaluated in the trial. It is not advisable to administer NSAIDS to these groups of patients. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Carbonic anhydrase 2 | Humans | inhibitor |
| Carbonic anhydrase 3 | Humans | inhibitor |
ADME / PK
| Absorption | Celecoxib is absorbed rapidly in the gastrointestinal tract. When a single oral dose of 200 mg was given to healthy research subjects, the peak plasma levels of celecoxib occurred within 3 hours. The Cmax is 705 ng/mL. When multiple doses are given, steady-state concentrations are reached on or before day 5. When taken with a high-fat meal, peak plasma levels are delayed for about 1 to 2 hours with an increase in total absorption (AUC) of 10% to 20%. The AUC of celecoxib has been shown to be significantly lower in patients with chronic renal impairment. A meta-analysis of pharmacokinetic studies has suggested an approximately 40% higher AUC (area under the curve) of celecoxib in black patients compared to Caucasians for unknown reasons. |
|---|---|
| Half-life | The effective half-life of celecoxib is approximately 11 hours when a single 200 mg dose is given to healthy subjects. The terminal half-life of celecoxib varies because of its low solubility, which prolongs absorption. |
| Protein binding | The protein binding of celecoxib is 97%, and it is primarily bound to albumin. |
| Metabolism | A large part of celecoxib metabolism is mediated by cytochrome P450 2C9 in the liver with some contribution from CYP3A4 and CYP2C8 and possible contributions from CYP2D6. It is metabolized by biotransformation to carboxylic acid and glucuronide metabolites. Three metabolites, a primary alcohol, a carboxylic acid, and a glucuronide conjugate, have been found in human plasma after celecoxib administration. These are considered inactive metabolites in regards to COX enzyme inhibition. Patients who are known or suspected to have decreased cytochrome P450 2C9 activity or function, based on their previous history, should be administered celecoxib with caution as they may have abnormally high serum concentrations resulting from decreased metabolism celecoxib. |
| Route of elimination | Celecoxib is primarily eliminated by hepatic metabolism with small amounts (<3%) of the unchanged drug found in both the urine and feces. About 57% of an oral dose of celecoxib is excreted in the feces and 27% is found to be excreted into the urine in the form of metabolites. The main metabolite in urine and feces is identified as the carboxylic acid metabolite (73%). The amount of glucuronide in the urine is reported to be low. |
| Volume of distribution | The apparent volume of distribution of celecoxib at steady state (Vss/F) is about 429 L, which suggests wide distribution into various tissues. Celecoxib is not preferentially bound to red blood cells. Another resource reports a volume of distribution of 455 ± 166L. |
| Clearance | Apparent clearance (CL/F), single oral 200 mg dose, healthy subjects = 27.7 L/hr. Clearance may be decreased by about 47% in patients with chronic renal insufficiency, according to a pharmacokinetic study. Studies have not been performed in patients with severe renal impairment. |
Formulation & handling
- Celecoxib is a small molecule NSAID primarily formulated for oral administration, also available in topical forms.
- It has low water solubility and high lipophilicity (LogP 4.01), which may impact dissolution and bioavailability in oral formulations.
- To reduce gastrointestinal irritation risks, avoid concomitant alcohol and separate from multivalent ion-containing products by several hours.
Regulatory status
| Lifecycle | The API is marketed in Canada, the US, and the EU, with initial patent protections expiring between 2014 and 2018, while later patents in the US extend exclusivity through 2038. This positions the API in a mature market phase with ongoing patent coverage influencing competitive dynamics. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Celecoxib is manufactured by a limited number of originator companies, with multiple packagers supporting broad distribution. Branded products are available across key markets including the US, EU, and Canada. While some patents remain active with expiry dates extending into 2030 and beyond, earlier patents have already expired, supporting the presence of generic competition in these regions. |
|---|
Safety
| Toxicity | The oral TDLo in humans 5.71 mg/kg. It is not advisable to administer celecoxib in patients with renal impairment or advanced hepatic impairment, as this may lead to increased serum concentrations, causing toxicity. Symptoms of overdose may include breathing difficulties, coma, drowsiness, gastrointestinal bleeding, high blood pressure, kidney failure, nausea, sluggishness, stomach pain, and vomiting. Because serious gastrointestinal tract ulceration and bleeding can occur without preceding symptoms, patients should be monitored for signs/symptoms of gastrointestinal bleeding. Symptomatic and supportive measures should be taken in a celecoxib overdose. The induction of emesis or administration of active charcoal should take place if the patient is seen within 4 hours of celecoxib ingestion. Diuresis, urinary alkalinization, hemodialysis, or hemoperfusion may not be useful in a celecoxib overdose due to its high level of protein binding. |
|---|
- Oral exposure in humans has a reported lowest observed dose (TDLo) of 5
- 71 mg/kg, indicating potential toxicity at low doses
- High protein binding limits effectiveness of extracorporeal elimination techniques such as hemodialysis or hemoperfusion in overdose situations
Celecoxib 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.
Celecoxib (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.
Celecoxib API manufacturers & distributors
Compare qualified Celecoxib API suppliers worldwide. We currently have 37 companies offering Celecoxib 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.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CEP, CoA, GMP, GDP, JDMF, KDMF, MSDS, USDMF | 243 products |
| Chemsynlab | Producer | China | China | CoA | 11 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Dongbang FTL | Producer | South Korea | South Korea | CEP, CoA, EDMF/ASMF, JDMF, KDMF | 13 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Erregierre | Producer | Italy | Italy | CoA, GMP, USDMF | 44 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Hikal | Producer | India | India | CEP, CoA, GMP, USDMF | 26 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 155 products |
| Micro Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 38 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| PharmaZell | Producer | Germany | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, KDMF, MSDS, USDMF, WC, WHO-GMP | 31 products |
| Punjab Chemicals & Crop | Producer | India | India | CoA, GMP, WC | 5 products |
| Qilu Tianhe | Producer | China | China | CEP, CoA, GMP, WC | 16 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP | 51 products |
| Raks Pharma | Producer | India | India | CEP, CoA, FDA, USDMF | 58 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sai-Tech Pharmaceuticals ... | Producer | India | India | CoA | 8 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Chenghui Shuangd... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, WC | 98 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shin Poong Pharm | Producer | South Korea | South Korea | CoA, JDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 764 products |
| Strides Pharma Science | Producer | India | Unknown | CEP, CoA, GMP | 14 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tianjin Tianyao | Producer | China | China | CoA, USDMF | 24 products |
| WATERSTONE PHARMACEUTICAL... | Producer | China | China | CoA, USDMF | 4 products |
| Watson Pharma | Producer | India | India | CoA, GMP, WC | 5 products |
| Zhejiang Chemsyn | Producer | China | China | CoA | 9 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP | 69 products |
| Zhejiang Yongtai Pharma | Producer | China | China | CoA, USDMF | 5 products |
When sending a request, specify which Celecoxib 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 Celecoxib 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.
