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Ketorolac Tromethamine

Ketorolac Tromethamine API

Ketorolac Tromethamine-API

CAS Number: 74103-07-4

Therapeutic Category
Pain Management
API Technology
Dose Form
Oral Solids
Dr Reddy's Development Status
Available Regulatory Filing
China DMF
CEP Granted
Brazil DMF
Korea DMF
Russia DMF
Saudi Arabia
Innovator Brand (USA)
No Document Available

Mechanism of Action

Ketorolac has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of SPRIX, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2), an early component of the arachidonic acid cascade, resulting in the reduced synthesis of prostaglandins, thromboxanes, and prostacyclin.

Ketorolac is a potent inhibitor of prostaglandin synthesis in vitro. Ketorolac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because ketorolac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.


SPRIX is a nonsteroidal anti-inflammatory drug indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Ketorolac Tromethamine API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Ketorolac Tromethamine API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.


Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

50 kg or more: 31.5 mg every 6 to 8 hours; less than 50 kg: 15.75 mg (1 spray in each nostril). 15 or 30 mg, injected into a muscle or a vein four times a day.

To relieve moderately severe pain, usually after surgery.

It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

We offer Crystalline form

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