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Meloxicam | CAS No: 71125-38-7 | GMP-certified suppliers
A medication that provides reliable relief for arthritis, osteoarthritis, juvenile rheumatoid arthritis, and supports postsurgical pain control across key therapeutic and procedural settings for diverse patient needs.
Therapeutic categories
Primary indications
- Meloxicam is indicated for the symptomatic treatment of arthritis and osteoarthritis
- In addition, it is indicated for the pauciarticular and polyarticular course of Juvenile Rheumatoid Arthritis (JRA) in patients aged 2 years old or above
- Off-label uses include the treatment of dental or post-surgical pain
- In addition to the above, meloxicam has also been studied in the treatment of neuropathic pain
Product Snapshot
- Meloxicam is a small-molecule NSAID available in oral, injectable, rectal, and topical formulations
- It is used for symptomatic management of arthritis, juvenile rheumatoid arthritis, and postsurgical pain, with additional off‑label and exploratory applications in dental and neuropathic pain
- It is approved for human and veterinary use in the US, EU, and Canada
Clinical Overview
Meloxicam exerts anti‑inflammatory, analgesic, and antipyretic effects through inhibition of prostaglandin synthetase enzymes COX‑1 and COX‑2. It shows preferential inhibition of COX‑2, which may lower but does not eliminate the risk of gastrointestinal mucosal injury. Reduced prostaglandin synthesis attenuates inflammatory mediator activity and limits sensitization of pain receptors. In clinical settings, meloxicam decreases markers of inflammation such as ESR and CRP.
The drug has a relatively long elimination half‑life, enabling once‑daily dosing. It is metabolized primarily via cytochrome P450 enzymes, including CYP2C9, CYP2C8, and CYP3A pathways. Systemic exposure can be influenced by hepatic impairment or by coadministration of inhibitors or inducers of these enzymes. Renal elimination accounts for a portion of cleared metabolites.
Safety considerations align with those of other NSAIDs. Meloxicam carries risks of gastrointestinal bleeding or ulceration, renal function decline, fluid retention, hypertension, and thrombotic cardiovascular events. Gastrointestinal events may occur at a somewhat lower incidence than with some nonselective NSAIDs, though clinically relevant risk remains. Hyperkalemia has been reported, particularly in patients with renal compromise or those receiving interacting therapies.
Common usage contexts include oral, transdermal, and intravenous formulations, depending on regional availability.
For API procurement, suppliers should provide evidence of compliant synthesis routes, control of benzothiazine‑related impurities, validated stability data, and robust characterization aligned with pharmacopeial specifications to support formulation and regulatory needs.
Identification & chemistry
| Generic name | Meloxicam |
|---|---|
| Molecule type | Small molecule |
| CAS | 71125-38-7 |
| UNII | VG2QF83CGL |
| DrugBank ID | DB00814 |
Pharmacology
| Summary | Meloxicam is a nonsteroidal anti‑inflammatory drug that reduces inflammatory, analgesic, and pyretic signaling by inhibiting prostaglandin synthesis through COX‑2–preferential blockade with additional COX‑1 activity. This suppression of prostaglandin pathways decreases inflammatory mediator production and neuronal sensitization to pain. Its pharmacodynamic profile reflects COX‑2–dominant inhibition with residual COX‑1 effects that contribute to gastrointestinal risk. |
|---|---|
| Mechanism of action | Meloxicam inhibits prostaglandin synthetase (cylooxygenase 1 and 2) enzymes leading to a decreased synthesis of prostaglandins, which normally mediate painful inflammatory symptoms.As prostaglandins sensitize neuronal pain receptors, inhibition of their synthesis leads to analgesic and inflammatory effects. Meloxicam preferentially inhibits COX-2, but also exerts some activity against COX-1, causing gastrointestinal irritation. |
| Pharmacodynamics | Meloxicam is an anti-inflammatory, analgesic analgesic with antipyretic effects in fever.Prostaglandins are substances that contribute to inflammation.This drug also exerts preferential actions against COX-2, which may reduce the possible gastrointestinal effects of this drug. In humans, meloxicam has demonstrated the ability to decrease erythrocyte sedimentation rate(ESR) in patients with rheumatoid arthritis, and to decrease ESR, C-reactive protein (CRP), as well as aquaporin-1 expression.As with other NSAIDS, prolonged use of meloxicum can result in renal or cardiovascular impairment or thrombotic cardiovascular events. A note on gastrointestinal effects As meloxicam preferentially inhibits COX-2, it is thought to cause less gastrointestinal irritation compared to other NSAIDS. Despite this, it still carries a risk of gastric inflammation, bleeding and ulceration.In one study, patients on meloxicam suffered from gastrointestinal symptoms at a rate of 13% compared to 19% of those on [diclofenac]. GI events were found to be less severe in the meloxicam-treated patients. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | The absolute bioavailability oral capsules after a dose was 89% in one pharmacokinetic study. Cmax was reached 5–6 hours after administration of a single dose given after the first meal of the day. The Cmax doubled when the drug was administered in the fasting state. Despite this, meloxicam can be taken without regard to food, unlike many other NSAIDS. Meloxicam formulated for instillation with [bupivacaine] produced varied systemic measures following a single dose of varying strength. In patients undergoing bunionectomy, 1.8 mg of meloxicam produced a C<sub>max</sub> of 26 ± 14 ng/mL, a median T<sub>max</sub> of 18 h, and an AUC<sub>∞</sub> of 2079 ± 1631 ng\*h/mL. For a 9 mg dose used in herniorrhaphy, the corresponding values were 225 ± 96 ng/mL, 54 h, and the AUC<sub>∞</sub> was not reported. Lastly, a 12 mg dose used in total knee arthroplasty produced values of 275 ± 134 ng/mL, 36 h, and 25,673 ± 17,666 ng\*h/mL. |
|---|---|
| Half-life | The half-life of meloxicam is approximately 20 hours, which is considerably longer than most other NSAIDS. It can therefore be dosed without the need for slow-release formulations. Meloxicam applied together with [bupivacaine] for postsurgical analgesia had a median half-life of 33-42 hours, depending on dose and application site. |
| Protein binding | Meloxicam is about 99.4% protein bound, primarily to albumin. |
| Metabolism | Meloxicam is almost completely metabolized. CYP2C9 is the main enzyme responsible for the metabolism of meloxicamwith minor contributions from CYP3A4.Meloxicam has 4 major metabolites with no activity determined. About 60% of the ingested dose is metabolized to 5'-carboxy meloxicam from hepatic cytochrome enzyme oxidation of an intermediate metabolite, 5’-hydroxymethylmeloxicam.Two other metabolites are likely produced via peroxidation. |
| Route of elimination | Meloxicam is mainly eliminated through metabolism. Its metabolites are cleared through renal and fecal elimination.Less than <0.25% of a dose is eliminated in the urine as unchanged drug.About 1.6% of the parent drug is excreted in the feces. |
| Volume of distribution | The volume of distribution of meloxicam is 10-15L. Because of its high binding to albumin, it is likely to be distributed in highly perfused tissues, such as the liver and kidney.Meloxicam concentrations in synovial fluid, measured after an oral dose, is estimated at 40% to 50% of the concentrations measured in the plasma.This drug is known to cross the placenta in humans. |
| Clearance | After an oral dose, the total clearance of meloxicam is 0.42–0.48 L/h.The FDA label indicates a plasma clearance from 7 to 9 mL/min. No dose changes are required in mild to moderate renal or hepatic impairment. The use of meloxicam in patients with severe renal or hepatic impairment has not been studied. FDA prescribing information advises against it. |
Formulation & handling
- Oral formulations require solubility‑enhancing approaches due to low aqueous solubility, though absorption is not food‑dependent.
- Parenteral solutions need appropriate cosolvents or pH adjustment to maintain solubility and prevent precipitation during storage and administration.
- Topical, ophthalmic, and rectal products leverage the API’s small‑molecule stability, with standard protection from light and oxidation typically sufficient.
Regulatory status
| Lifecycle | The API remains partly protected in the United States by multiple patents extending through 2035, suggesting a maturing but not yet fully generic‑exposed market. With products present in Canada, the US, and the EU, overall lifecycle status reflects established global availability alongside ongoing U.S. exclusivity for certain protected elements. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Meloxicam’s originator is associated with Boehringer Ingelheim, but the market is now dominated by a broad set of global generic manufacturers and packagers, indicating a mature and well‑established supply base. Branded and generic products are available in the US, EU, and Canada, reflecting wide international distribution. Core substance patents have expired, and the remaining US patents relate mainly to later formulations, allowing extensive existing generic competition. |
|---|
Safety
| Toxicity | The oral LD50 in rats is 98 mg/kg.Signs and symptoms of overdose with meloxicam may include shallow breathing, seizure, decreased urine output, gastrointestinal irritation, nausea, vomiting, gastrointestinal bleeding, and black tarry stools.In the case of an overdose, offer supportive treatment and attempt to remove gastrointestinal contents. Cholestyramine has been shown to enhance the elimination of meloxicam. |
|---|
- Acute toxicity profile includes an oral LD50 of approximately 98 mg/kg in rats
- Overdose exposure is associated with CNS depression, seizure activity, and significant gastrointestinal irritation or bleeding
- Excessive systemic levels may manifest with reduced respiratory drive and decreased renal output, indicating potential risk to renal and respiratory systems during high‑dose exposure
Meloxicam 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.
Meloxicam (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.
Meloxicam API manufacturers & distributors
Compare qualified Meloxicam API suppliers worldwide. We currently have 30 companies offering Meloxicam API, with manufacturing taking place in 9 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 |
|---|---|---|---|---|---|
| Amsa S.P.A. | Producer | Italy | Italy | CoA, EDMF/ASMF, GMP, JDMF | 10 products |
| Apex Healthcare | Producer | India | India | CoA, JDMF | 9 products |
| Arch Pharmalabs | Producer | India | India | CoA, GMP, USDMF, WC | 19 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 176 products |
| Atilus Pharma | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, HALAL, Kosher, MSDS | 11 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, JDMF, KDMF, MSDS, USDMF | 243 products |
| Bidachem | Producer | Italy | Italy | CoA, GMP, USDMF | 14 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO14001, ISO9001, MSDS | 235 products |
| Cipla | Producer | India | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Darshan Pharmachem (P) Li... | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 10 products |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP, JDMF, USDMF | 18 products |
| Dongbang FTL | Producer | South Korea | South Korea | CoA, EDMF/ASMF, JDMF, KDMF | 13 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hwail Pharm | Producer | South Korea | South Korea | CoA, JDMF | 4 products |
| Il Shin Chemical Co | Producer | South Korea | South Korea | CoA, JDMF | 3 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Micro Labs | Producer | India | India | CEP, CoA, FDA, GMP | 38 products |
| Nantong Jinghua | Producer | China | China | CoA | 12 products |
| Norbrook Labs | Producer | Ireland | Ireland | CEP, CoA | 6 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, GMP, USDMF | 51 products |
| Ramdev Chemical | Producer | India | India | CoA, GMP, WC | 3 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Xinhua | Producer | China | China | CoA, USDMF, WC | 21 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Sun Pharma | Producer | India | India | CEP, CoA, KDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 62 products |
When sending a request, specify which Meloxicam 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 Meloxicam 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 Meloxicam API
Sourcing
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Technical
What is Meloxicam (CAS 71125-38-7) used for?
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Is Meloxicam a small molecule?
Are there special stability concerns for oral Meloxicam?
Regulatory
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Pharmaoffer
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