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Ketorolac | CAS No: 74103-06-3 | GMP-certified suppliers
A medication that provides short‑term relief of acute postoperative, musculoskeletal, and arthritic pain requiring opioid‑level analgesia while avoiding dependence concerns.
Therapeutic categories
Primary indications
- Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and has antipyretic, analgesic and anti-inflammatory properties
- It is indicated for short term management of acute pain that requires the calibre of pain management offered by opioids
- Clinicians may choose to initiate ketorolac to manage post-operative pain, spinal and soft tissue pain, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, menstrual disorders and headaches among other ailments
- Regardless of the etiology of pain, patients should use the lowest possible dose, and avoid using ketorolac for an extended period of time (ideally ≤ 5 days)
Product Snapshot
- Ketorolac is a small‑molecule NSAID supplied in injectable, oral, ophthalmic, nasal, and topical formulations
- It is used for short‑term management of moderate to severe acute pain across surgical, musculoskeletal, and ocular settings
- It is approved in major regulated markets including the US, Canada, and the EU
Clinical Overview
Ketorolac exerts analgesic, anti‑inflammatory, and antipyretic activity through inhibition of cyclooxygenase enzymes. It is administered as a racemic mixture, with the S‑enantiomer contributing most of the pharmacological effect. Non‑selective inhibition of COX‑1 and COX‑2 reduces prostaglandin synthesis. COX‑2 inhibition underlies the desired analgesic and anti‑inflammatory actions, while COX‑1 inhibition affects platelet function and gastric mucosal protection, contributing to bleeding risk and ulceration. Long‑term use is avoided due to the potential for serious gastrointestinal injury and renal toxicity.
Absorption varies by route, with rapid systemic exposure following parenteral and intranasal administration. Protein binding is high, and the drug undergoes hepatic metabolism primarily through glucuronidation, with minor involvement of CYP2C8 and CYP2C9 pathways. Renal excretion is the main elimination route, making dose adjustment necessary in renal impairment or in older adults. Ketorolac is associated with risks of gastrointestinal bleeding, renal adverse events, hypertension, fluid retention, and hypersensitivity in patients with NSAID intolerance. It may impair platelet aggregation and prolong bleeding time. Ophthalmic formulations achieve local anti‑inflammatory effects with minimal systemic exposure.
Ketorolac is marketed under various brand names worldwide across dosage forms used in perioperative care and ambulatory pain management.
For API procurement, suppliers should provide evidence of compliance with pharmacopeial specifications, consistent control of enantiomeric composition, validated impurity profiles, and robust documentation supporting stability, traceability, and compliance with global regulatory standards.
Identification & chemistry
| Generic name | Ketorolac |
|---|---|
| Molecule type | Small molecule |
| CAS | 74103-06-3 |
| UNII | YZI5105V0L |
| DrugBank ID | DB00465 |
Pharmacology
| Summary | Ketorolac is a non‑selective NSAID that inhibits COX‑1 and COX‑2, reducing prostaglandin synthesis involved in pain, inflammation, and fever. Its therapeutic effects stem primarily from COX‑2 blockade, while COX‑1 inhibition accounts for platelet and gastrointestinal effects. The drug is administered as a racemic mixture, with the S‑enantiomer responsible for most pharmacologic activity. |
|---|---|
| Mechanism of action | Ketorolac inhibits key pathways in prostaglandin synthesis which is crucial to it's mechanism of action.Although ketorolac is non-selective and inhibits both COX-1 and COX-2 enzymes, it's clinical efficacy is derived from it's COX-2 inhibition. The COX-2 enzyme is inducible and is responsible for converting arachidonic acid to prostaglandins that mediate inflammation and pain. By blocking this pathway, ketorolac achieves analgesia and reduces inflammation.Ketorolac is administered as a racemic mixture; however, the "S" enantiomer is largely responsible for it's pharmacological activity. |
| Pharmacodynamics | Ketorolac is a non-selective NSAID and acts by inhibiting both COX-1 and COX-2 enzymes which are normally responsible for converting arachidonic acid to prostaglandins. The COX-1 enzyme is constitutively active and can be found in platelets, gastric mucosa, and vascular endothelium. On the other hand, the COX-2 enzyme is inducible and mediates inflammation, pain and fever. As a result, inhibition of the COX-1 enzyme is linked to an increased risk of bleeding and risk of gastric ulceration, while the desired anti-inflammatory and analgesic properties are linked to inhibition of the COX-2 enzyme.Therefore, despite it's effectiveness in pain management, ketorolac should not be used long-term since this increases the risk of serious adverse effects such as gastrointestinal bleeding, peptic ulcers, and perforations. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Ketorolac is rapidly, and completely absorbed after oral administration with a bioavailability of 80% after oral administration.[L3674L3674L3674]Cmax is attained 20-60 minutes after administration, and after intramuscular administration, the area under the plasma concentration-time curve (AUC) is proportional to the dose administered. After intramuscular administration, ketorolac demonstrates a time to maximal plasma concentration (tmax) of approximately 45-50 minutes, and a tmax of 30-40 minutes after oral administration.The rate of absorption may be reduced by food; however, the extent of absorption remains unaffected. |
|---|---|
| Half-life | Ketorolac tromethamine is administered as a racemic mixture, therefore the half-life of each enantiomer must be considered. The half life of the S-enantiomer is ~2.5 hours, while the half life of the R-enantiomer is ~5 hours. Based on this data, the S enantiomer is cleared about twice as fast as the R enantiomer. |
| Protein binding | >99% of Ketorolac is plasma protein bound. |
| Metabolism | Ketorolac is heavily metabolized via hydroxylation or conjugation in the liver; however, it appears that the key metabolic pathway is glucuronic acid conjugation.Enzymes involved in phase I metabolism include CYP2C8 and CYP2C9, while phase II metabolism is carried out by UDP-glucuronosyltransferase (UGT) 2B7. |
| Route of elimination | Ketorolac is primarily renally eliminated and approximately 92% of the dose can be recovered in the urine with 60% of this proportion recovered unchanged, and 40% recovered as metabolites. In addition 6% of a single dose is eliminated in the feces. |
| Volume of distribution | The apparent volume of distribution of ketorolac in healthy human subjects is 0.25 L/kg or less. |
| Clearance | The plasma clearance of ketorolac is 0.021 to 0.037 L/h/kg.Further, studies have illustrated that clearance of oral, IM and IV doses of ketorolac are comparable which suggests linear kinetics.It should also be noted that clearance in children is about double the clearance found in adults. |
Formulation & handling
- Oral formulations may benefit from food co‑administration to reduce GI irritation, but food has no meaningful impact on drug stability or absorption characteristics.
- Parenteral and ophthalmic products use aqueous solutions; modest water solubility may require pH adjustment or solubilizers to maintain clarity and prevent precipitation.
- The small‑molecule, solid-state API is chemically stable under typical handling but requires protection from moisture to avoid dissolution or clumping during formulation.
Regulatory status
| Lifecycle | Most original North American patent protection expired between 2009 and 2011, with remaining U.S. patents extending coverage into 2024–2027, indicating the product is moving into a late‑lifecycle phase. Across the US, Canada, and EU markets, this timing suggests increasing generic availability as the final U.S. patents lapse. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Ketorolac has long-established originators, with Allergan and related legacy entities supplying branded products such as Acular while a large number of manufacturers and packagers now participate in production and distribution. Branded and generic forms are available across the US, Canada, and the EU, reflecting broad global presence. Core substance patents have expired, and remaining later‑dated US patents appear to be formulation‑related, supporting the existing mature generic competition. |
|---|
Safety
| Toxicity | The rate of adverse effects increases with higher doses of ketorolac. The most frequently observed adverse effects in patients occurring with an incidence of greater than 10% include: abdominal pain, dyspepsia, nausea, and headaches.Most adverse effects associated with short term use are mild in nature, related to the gastrointestinal tract and nervous system, and occur in roughly 39% of patients.Common symptoms of ketorolac overdose include nausea, vomiting, epigastric pain, gastrointestinal bleeding, lethargy and drowsiness. More rare symptoms of overdose include acute renal failure, hypertension, respiratory depression, and coma. Ketorolac is classified as Pregnancy Category C since there is a lack of evidence demonstrating safety in pregnant women.NSAIDs including ketorolac increase the risk of premature closure of the fetal ductus arteriosus in the 3rd trimester; therefore, beginning at 30 weeks gestation, pregnant women should avoid ketorolac. Ketorolac has been shown to be excreted in breast milk, and although available data has not demonstrated any adverse effects in nursing infants, practitioners should proceed with caution when suggesting ketorolac for nursing mothers.The benefits should outweigh the risks and the mother should be counselled to monitor the infant closely and to contact the infant's healthcare provider should any adverse effects arise. Women who are trying to conceive are not advised to take ketorolac since it's effect on prostaglandin synthesis may impair fertility.[L11055L11055] |
|---|
- Dose‑dependent adverse effects are common, with gastrointestinal and CNS events (abdominal pain, dyspepsia, nausea, headache) occurring in over 10% of exposed subjects and overall event rates near 39% in short‑term use
- Overdose profiles include prominent gastrointestinal irritation and CNS depression, with less frequent progression to acute renal failure, hypertension, respiratory depression, or coma
- Classified as Pregnancy Category C
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Ketorolac is a type of Non-opioid analgesics
Non-opioid analgesics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used for the management of pain. Unlike opioids, which are known to have addictive properties, non-opioid analgesics offer pain relief without the risk of dependence or addiction.
These APIs work by inhibiting the production of prostaglandins, which are substances in the body that contribute to pain and inflammation. Non-opioid analgesics are typically available over-the-counter (OTC) and come in various forms such as tablets, capsules, creams, and gels.
One of the most common non-opioid analgesics is acetaminophen, which is highly effective in relieving mild to moderate pain. It is commonly used to alleviate headaches, toothaches, and musculoskeletal pain. Another popular non-opioid analgesic is non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen. These medications not only reduce pain but also have anti-inflammatory properties, making them particularly useful for conditions such as arthritis.
Non-opioid analgesics are generally well-tolerated but can have potential side effects, including gastrointestinal disturbances and, in rare cases, liver or kidney damage. It is important to follow recommended dosages and consult a healthcare professional if there are any concerns or underlying medical conditions.
In conclusion, non-opioid analgesics are a vital category of pharmaceutical APIs that offer effective pain relief without the risk of addiction. Their accessibility, diverse formulations, and relatively favorable safety profile make them a popular choice for individuals seeking relief from various types of pain.
Ketorolac (Non-opioid analgesics), classified under Analgesics
Analgesics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are commonly used to relieve pain. They are designed to alleviate discomfort by targeting the body's pain receptors or by reducing inflammation. Analgesics are widely utilized in the medical field to manage various types of pain, ranging from mild to severe.
One of the primary classes of analgesics is nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the production of prostaglandins, substances that contribute to pain and inflammation. This class includes well-known drugs like ibuprofen and naproxen. Another class of analgesics is opioids, which are derived from opium or synthetic compounds that mimic the effects of opium. Opioids act on the central nervous system to reduce pain perception and provide potent pain relief. Examples of opioids include morphine, codeine, and oxycodone.
Analgesics are available in various forms, such as tablets, capsules, creams, and injections, allowing for different routes of administration based on the patient's needs. They are commonly used to manage pain associated with conditions like arthritis, headaches, dental procedures, and post-operative recovery.
It is important to note that analgesics should be used under medical supervision, as improper use or overuse can lead to adverse effects, including gastrointestinal complications, addiction, and respiratory depression in the case of opioids. Therefore, it is crucial for healthcare professionals to assess each patient's individual needs and prescribe the appropriate analgesic and dosage.
In summary, analgesics are a vital category of pharmaceutical APIs used to alleviate pain by targeting pain receptors or reducing inflammation. With various classes and forms available, they provide valuable options for pain management when used responsibly and under medical guidance.
Ketorolac API manufacturers & distributors
Compare qualified Ketorolac API suppliers worldwide. We currently have 18 companies offering Ketorolac 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Chromo Labs. | Producer | India | India | CoA, GMP, WC | 11 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC | 170 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Farmak | Producer | Czech Republic | Czech Republic | CoA, USDMF | 19 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| Quimdis | Distributor | France | Unknown | CoA | 17 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, USDMF | 51 products |
| Recordati S.p.A. | Producer | Italy | Italy | CEP, CoA, FDA, KDMF, USDMF | 18 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong N.T. Pharma | Producer | China | China | CoA, USDMF | 12 products |
| Symed Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 28 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, MSDS, USDMF, WC | 37 products |
When sending a request, specify which Ketorolac 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 Ketorolac 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 Ketorolac API
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Technical
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Regulatory
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