Ibuprofen API from Indian Manufacturers & Suppliers
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Ibuprofen | CAS No: 15687-27-1 | GMP-certified suppliers
A medication that relieves mild to moderate pain, reduces fever, and supports symptomatic management of common inflammatory and rheumatic conditions across key therapeutic markets.
Therapeutic categories
Primary indications
- Ibuprofen is the most commonly used and prescribed NSAID
- It is a very common over-the-counter medication widely used as an analgesic, anti-inflammatory and antipyretic
- The use of ibuprofen and its enantiomer in a racemic mix is common for the management of mild to moderate pain related to dysmenorrhea, headache, migraine, postoperative dental pain, spondylitis, osteoarthritis, rheumatoid arthritis, and soft tissue disorder
Product Snapshot
- Ibuprofen is an oral small‑molecule NSAID available in multiple solid, liquid, topical, and parenteral formulations
- It is used for analgesic, anti‑inflammatory, and antipyretic applications across musculoskeletal disorders, general pain indications, and selected neonatal uses
- It is an approved API in the US, Canada, and EU
Clinical Overview
Clinically, ibuprofen is used for mild to moderate pain, fever reduction, and symptomatic management of inflammatory and rheumatic disorders. Additional established uses include dysmenorrhea, migraine, postoperative dental pain, spondylitis, osteoarthritis, and rheumatoid arthritis. In neonatology, ibuprofen is used for pharmacologic closure of patent ductus arteriosus through prostaglandin E2 suppression. High-dose regimens have been studied in cystic fibrosis to modulate airway inflammation. Its sodium-retaining effect has been applied in selected cases of orthostatic hypotension.
Ibuprofen exerts its activity through non‑selective inhibition of cyclooxygenase isoforms COX‑1 and COX‑2, reducing prostaglandin and thromboxane synthesis. This leads to peripheral and central modulation of nociceptive signaling, suppression of fever via hypothalamic prostaglandin reduction, and attenuation of inflammatory pathways. Investigational findings have explored potential neuroprotective effects in chronic neurodegenerative conditions and possible associations with breast cancer risk reduction, though these remain non‑standard uses.
Absorption after oral administration is rapid, with high protein binding and hepatic metabolism primarily via oxidation and glucuronidation through CYP2C8, CYP2C9, and UGT pathways. Ibuprofen and its metabolites are largely excreted renally. The compound crosses the blood–brain barrier, consistent with central antipyretic and analgesic effects.
Safety considerations include gastrointestinal ulceration related to COX‑1 inhibition, nephrotoxicity with volume depletion or chronic exposure, and effects on platelet aggregation and gestational physiology due to thromboxane and prostaglandin suppression. Cardiovascular, renal, and gastrointestinal risks guide dosing and treatment duration.
Common global brands include prescription and non‑prescription formulations in oral, injectable, and topical forms.
For API procurement, suppliers should provide evidence of stereochemical integrity, control of oxidative and residual solvent impurities, and compliance with pharmacopeial specifications such as particle size, assay, and related substances to support consistent formulation performance.
Identification & chemistry
| Generic name | Ibuprofen |
|---|---|
| Molecule type | Small molecule |
| CAS | 15687-27-1 |
| UNII | WK2XYI10QM |
| DrugBank ID | DB01050 |
Pharmacology
| Summary | Ibuprofen is a non‑selective inhibitor of COX‑1 and COX‑2, reducing prostaglandin and thromboxane synthesis within the arachidonic acid pathway. This leads to broad modulation of inflammatory, nociceptive, and febrile signaling in peripheral tissues and the central nervous system. Its pharmacodynamic profile reflects suppression of prostanoid‑mediated pathways that drive pain, inflammation, and fever. |
|---|---|
| Mechanism of action | The exact mechanism of action of ibuprofen is unknown. However, ibuprofen is considered an NSAID and thus it is a non-selective inhibitor of cyclooxygenase, which is an enzyme involved in prostaglandin (mediators of pain and fever) and thromboxane (stimulators of blood clotting) synthesis via the arachidonic acid pathway. Ibuprofen is a non-selective COX inhibitor and hence, it inhibits the activity of both COX-1 and COX-2. The inhibition of COX-2 activity decreases the synthesis of prostaglandins involved in mediating inflammation, pain, fever, and swelling while the inhibition of COX-1 is thought to cause some of the side effects of ibuprofen including GI ulceration. |
| Pharmacodynamics | Ibuprofen has multiple actions in different inflammatory pathways involved in acute and chronic inflammation. The main effects reported in ibuprofen are related to the control of pain, fever and acute inflammation by the inhibition of the synthesis of prostanoids by COX-1 and COX-2. Pain relief is attributed to peripheral affected regions and central nervous system effects in the pain transmission mediated by the dorsal horn and higher spinothalamic tract. Some reports have tried to link the pain regulation with a possible enhancement on the synthesis of endogenous cannabinoids and action on the NMDA receptors. The effect on pain has been shown to be related to the cortically evoked potentials. The antipyretic effect is reported to be linked to the effect on the prostanoid synthesis due to the fact that the prostanoids are the main signaling mediator of pyresis in the hypothalamic-preoptic region. The use of ibuprofen in dental procedures is attributed to the local inhibition of prostanoid production as well as to anti-oedemic activity and an increase of plasma beta-endorphins. Some reports have suggested a rapid local reduction of the expression of COX-2 in dental pulp derived by the administration of ibuprofen. The administration of ibuprofen in patients with rheumatic diseases has shown to control joint symptoms. Ibuprofen is largely used in OTC products such as an agent for the management of dysmenorrhea which has been proven to reduce the amount of menstrual prostanoids and to produce a reduction in the uterine hypercontractility.As well, it has been reported to reduce significantly the fever and the pain caused by migraines.This effect is thought to be related to the effect on platelet activation and thromboxane A2 production which produces local vascular effects in the affected regions. This effect is viable as ibuprofen can enter in the central nervous system. In the investigational uses of ibuprofen, it has been reported to reduce neurodegeneration when given in low doses over a long time.On the other hand, its use in Parkinson disease is related to the importance of inflammation and oxidative stress in the pathology of this condition.The use of ibuprofen for breast cancer is related to a study that shows a decrease of 50% in the rate of breast cancer. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Apoptosis regulator Bcl-2 | Humans | modulator |
ADME / PK
| Absorption | It is very well absorbed orally and the peak serum concentration can be attained in 1 to 2 hours after extravascular administration. When ibuprofen is administered immediately after a meal there is a slight reduction in the absorption rate but there is no change in the extent of the absorption. When orally administered, the absorption of ibuprofen in adults is very rapidly done in the upper GI tract.The average Cmax, Tmax and AUC ranges around 20 mcg/ml, 2 h and 70 mcg.h/ml. These parameters can vary depending on the enantiomer form, route, and dose of administration. |
|---|---|
| Half-life | The serum half-life of ibuprofen is 1.2-2 hours.In patients with a compromised liver function, the half-life can be prolonged to 3.1-3.4 hours. |
| Protein binding | Ibuprofen dosage is more than 99% bound to plasma proteins and site II of purified albumin, binding appears to be saturable and becomes non-linear at concentrations exceeding 20 mcg/ml. |
| Metabolism | Ibuprofen is rapidly metabolized and biotransformed in the liver to the formation of major metabolites which are the hydroxylated and carboxylated derivatives.As soon as it is absorbed, the R-enantiomer undergoes extensive enantiomeric conversion (53-65%) to the more active S-enantiomer _in vivo_ by the activity of alpha-methylacyl-CoA racemase. Ibuprofen metabolism can be divided in phase I which is represented by the hydroxylation of the isobutyl chains for the formation of 2 or 3-hydroxy derivatives followed by oxidation to 2-carboxy-ibuprofen and p-carboxy-2-propionate. These oxidative reactions are performed by the activity of the cytochrome P450 isoforms CYP 2C9, CYP 2C19 and CYP 2C8. Therefore, these enzymes participate in the oxidation of the alkyl side chain to hydroxyl and carboxyl derivatives. From this enzymes, the major catalyst in the formation of oxidative metabolites is the isoform CYP 2C9. The metabolic phase I is followed by a phase II in which the oxidative metabolites may be conjugated to glucuronide prior to excretion. This activity forms phenolic and acyl glucuronides. |
| Route of elimination | Ibuprofen is rapidly metabolized and eliminated in the urine thus, this via accounts for more than 90% of the administered dose. It is completely eliminated in 24 hours after the last dose and almost all the administered dose goes through metabolism, representing about 99% of the eliminated dose.The biliary excretion of unchanged drug and active phase II metabolites represents 1% of the administered dose. In summary, ibuprofen is excreted as metabolites or their conjugates. The elimination of ibuprofen is not impaired by old age or the presence of renal impairment. |
| Volume of distribution | The apparent volume of distribution of ibuprofen is of 0.1 L/kg. |
| Clearance | The clearance rate ranges between 3-13 L/h depending on the route of administration, enantiomer type and dosage. |
Formulation & handling
- Oral formulations require solubility‑enhancing approaches due to low aqueous solubility and benefit from administration with food to reduce gastric irritation.
- Parenteral and ophthalmic preparations typically use solubilizers or alkaline solutions to keep the weak acid in solution and require pH control to maintain stability.
- Topical and rectal products use the solid, lipophilic API in dispersed systems where melting point and particle size distribution affect release and local absorption.
Regulatory status
| Lifecycle | The API’s core U.S. patents expired between 2010 and 2021, indicating a mature market with established generic presence. With products marketed in the US, Canada, and the EU, the ingredient is broadly commercialized and in a late lifecycle stage. |
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| Markets | US, Canada, EU |
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Supply Chain
| Supply chain summary | Ibuprofen has a single historical originator, but its core patents have long expired, and later formulation‑related patents listed here have also lapsed, placing the product firmly in the generic domain. Branded and private‑label products are widely available across the US, Canada, and the EU, supported by a large number of packagers and distributors rather than a small group of originator manufacturers. The expired patent landscape indicates well‑established generic competition with no remaining exclusivities expected to limit supply. |
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Safety
| Toxicity | The symptoms of overdose are presented in individuals that consumed more than 99 mg/kg. Most common symptoms of overdose are abdominal pain, nausea, vomiting, lethargy, vertigo, drowsiness (somnolence), dizziness and insomnia. Other symptoms of overdose include headache, loss of consciousness, tinnitus, CNS depression, convulsions and seizures. May rarely cause metabolic acidosis, abnormal hepatic function, hyperkalemia, renal failure, dyspnea, respiratory depression, coma, acute renal failure, and apnea (primarily in very young pediatric patients). The reported LD50 of ibuprofen is of 636 mg/kg in rat, 740 mg/kg in mouse and 495 mg/kg in guinea pig.[MSDS] |
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- Overdose exposure above roughly 99 mg/kg is associated with CNS depression, gastrointestinal distress, and neurologic effects including vertigo, somnolence, seizures, and loss of consciousness
- Severe toxicity may involve metabolic acidosis, abnormal hepatic function, hyperkalemia, renal impairment or failure, and respiratory depression, with apnea observed primarily in very young subjects
- Reported oral LD50 values range from approximately 495–740 mg/kg across rodent models, indicating moderate acute toxicity
Ibuprofen 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.
Ibuprofen (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.
Ibuprofen API manufacturers & distributors
Compare qualified Ibuprofen API suppliers worldwide. We currently have 21 companies offering Ibuprofen API, with manufacturing taking place in 7 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 | Unknown | CEP, CoA, FDA, GMP | 19 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF | 484 products |
| Hamari Chemicals | Producer | Japan | Japan | CoA, JDMF | 12 products |
| Hubei Biocause | Producer | China | China | CoA, USDMF | 12 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Piramal Pharma Solutions | Producer | India | Unknown | CEP, CoA, FDA, GMP | 44 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Salius Pharma Pvt Ltd | Distributor | India | India | CoA, FDA, GMP, MSDS, USDMF | 2 products |
| Shandong Xinhua | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 21 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| SI Group | Producer | United States | United States | CEP, CoA, FDA, USDMF | 2 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 764 products |
| Strides Pharma Science | Producer | India | India | CEP, CoA, GMP, WC | 14 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 146 products |
| Zhejiang NHU Company | Producer | China | China | CoA, GMP | 3 products |
| Zibo Xinhua-Perrigo Pharm... | Producer | China | China | CoA, USDMF | 1 products |
When sending a request, specify which Ibuprofen 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 Ibuprofen 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.
