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Mefenamic acid | CAS No: 61-68-7 | GMP-certified suppliers
A medication that relieves mild to moderate pain, dysmenorrhea, and inflammatory conditions such as rheumatoid arthritis and osteoarthritis for reliable symptom control.
Therapeutic categories
Primary indications
- For the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain, inflammation, and fever
Product Snapshot
- Mefenamic acid is a small‑molecule NSAID available in oral and parenteral formulations
- It is used for musculoskeletal inflammatory conditions and dysmenorrhea, as well as mild to moderate pain and fever
- It is an approved API in the US and Canada
Clinical Overview
Pharmacologically, mefenamic acid acts as a reversible inhibitor of cyclooxygenase isoenzymes COX‑1 and COX‑2, reducing the synthesis of prostaglandins that mediate inflammation, peripheral and central sensitization, and pyrogenic responses. Inhibition of prostanoid signaling contributes to attenuation of pain transmission and inflammatory hyperalgesia.
Absorption occurs following oral administration, with high protein binding typical of many acidic NSAIDs. Hepatic metabolism involves cytochrome P450 pathways, including CYP1A2, CYP2C8, and CYP2C9, and conjugation via UGT isoforms such as UGT1A9 and UGT2B7. Metabolites and unchanged drug are excreted primarily in urine and feces. The compound’s classification as both a CYP substrate and inhibitor indicates potential for metabolic interactions, particularly with agents dependent on similar pathways.
Safety considerations align with the broader NSAID class. Gastrointestinal irritation, ulceration, and bleeding risk are established concerns. Renal adverse effects may occur, particularly in patients with compromised renal perfusion, consistent with its categorization among nephrotoxic agents. Mefenamic acid may influence blood pressure and potassium homeostasis in susceptible individuals. Photosensitivity reactions have been reported. Use is generally limited to short-term regimens to mitigate risk. It is contraindicated in individuals with NSAID hypersensitivity or a history of aspirin-induced bronchospasm.
Mefenamic acid is marketed in various global regions, commonly as oral capsules or tablets for short-duration pain management and menstrual symptom control.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of polymorphic form, impurity profile, and residual solvent compliance, supported by current GMP certification and full regulatory documentation to facilitate dossier preparation.
Identification & chemistry
| Generic name | Mefenamic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 61-68-7 |
| UNII | 367589PJ2C |
| DrugBank ID | DB00784 |
Pharmacology
| Summary | Mefenamic acid is a fenamate NSAID that inhibits COX‑1 and COX‑2, reducing prostaglandin synthesis. This suppression of prostanoid signaling underlies its anti‑inflammatory, analgesic, and antipyretic effects. The drug’s therapeutic activity reflects modulation of pathways that mediate pain, inflammation, and fever. |
|---|---|
| Mechanism of action | Mefenamic acid binds the prostaglandin synthetase receptors COX-1 and COX-2, inhibiting the action of prostaglandin synthetase. As these receptors have a role as a major mediator of inflammation and/or a role for prostanoid signaling in activity-dependent plasticity, the symptoms of pain are temporarily reduced. |
| Pharmacodynamics | Mefenamic acid, an anthranilic acid derivative, is a member of the fenamate group of nonsteroidal anti-inflammatory drugs (NSAIDs). It exhibits anti-inflammatory, analgesic, and antipyretic activities. Similar to other NSAIDs, mefenamic acid inhibits prostaglandin synthetase. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Mefenamic acid is rapidly absorbed after oral administration. |
|---|---|
| Half-life | 2 hours |
| Protein binding | 90% |
| Metabolism | Mefenamic acid undergoes metabolism by CYP2C9 to 3-hydroxymethyl mefenamic acid, and further oxidation to a 3-carboxymefenamic acid may occur. The activity of these metabolites has not been studied. Mefenamic acid is also glucuronidated directly. |
| Route of elimination | The fecal route of elimination accounts for up to 20% of the dose, mainly in the form of unconjugated 3-carboxymefenamic acid.3 The elimination half-life of mefenamic acid is approximately two hours. Mefenamic acid, its metabolites and conjugates are primarily excreted by the kidneys. Both renal and hepatic excretion are significant pathways of elimination. |
| Volume of distribution | * 1.06 L/kg [Normal Healthy Adults (18-45 yr)] |
| Clearance | * Oral cl=21.23 L/hr [Healthy adults (18-45 yrs)] |
Formulation & handling
- Low aqueous solubility and high logP favor use of solubilizers or solid dispersion approaches for oral products, with attention to GI irritation that often necessitates food co‑administration.
- Parenteral powder-for-suspension forms require suitable wetting agents and controlled reconstitution to maintain uniformity and prevent precipitation.
- As a small, lipophilic acidic compound, it is compatible with conventional solid oral dosage formats but benefits from particle-size control to improve dissolution.
Regulatory status
| Lifecycle | Patent‑expiry details were not provided, so the lifecycle can only be described in general terms. In the US and Canadian markets, the API appears to be in a post‑patent, mature phase characterized by established generic availability and stable market dynamics. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Mefenamic acid originates from a single innovator manufacturer, with supply supported by multiple U.S.‑based packagers that handle distribution and finished‑dose presentation. The product is established in North American markets, with branded and unbranded versions available in both the United States and Canada. Patent expiry occurred years ago, enabling broad generic competition in all major markets. |
|---|
Safety
| Toxicity | Oral, rat LD<sub>50</sub>: 740 mg/kg. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, dark stool, ringing in the ears, change in amount of urine, unusually fast or slow heartbeat, muscle weakness, slow or shallow breathing, confusion, severe headache or loss of consciousness. |
|---|
- Rat oral LD50 is approximately 740 mg/kg, indicating moderate acute toxicity
- Control dust and avoid oral exposure during handling
- Overdose is associated with gastrointestinal bleeding–related manifestations (e
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Mefenamic acid 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.
Mefenamic acid (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.
Mefenamic acid API manufacturers & distributors
Compare qualified Mefenamic acid API suppliers worldwide. We currently have 16 companies offering Mefenamic acid 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 |
|---|---|---|---|---|---|
| Arch Pharmalabs | Producer | India | India | CEP, CoA, FDA, GMP, WC | 19 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF | 176 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 | CEP, CoA, GMP, GDP, KDMF, MSDS, USDMF | 243 products |
| Cheng Fong Chemical | Producer | Taiwan | Taiwan | CoA, JDMF, USDMF | 6 products |
| Dongbang FTL | Producer | South Korea | South Korea | CEP, CoA, GMP, KDMF | 13 products |
| G.C. Chemie Pharmie Ltd | Producer | India | India | CoA | 21 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 757 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, WC | 22 products |
| Wanbury | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 15 products |
| Wisdom Pharma | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 12 products |
| Yung Zip Chemical | Producer | Taiwan | Taiwan | CEP, CoA, FDA, USDMF | 12 products |
When sending a request, specify which Mefenamic 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.).
Use the list above to find high-quality Mefenamic acid 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 Mefenamic acid API
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Technical
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Regulatory
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Pharmaoffer
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