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dexketoprofen Tablets, film coated 25 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Bosnia And Herzegovina
GMP approvals
EU GMP
Available for
Licensing with supply, Distribution only
Comments
Indication - rheumatic and musculoskeletal disorders, dysmenorrhoea and other painful conditions Type of application - generic
Manufacturer #21530

The CTD dossier owner and manufacturer is the largest industrial manufacturer of medicines in western Balkan, operating for more than 70 years. The manufacturer produces an extensive array of medications for oral, injectable, and topical administration, targeting various bodily systems including the digestive system, metabolism, cardiovascular system, systemic infections, skin health, musculoskeletal system, nervous system, and respiratory system. Additionally, the company specializes in systemic hormone drugs, excluding those related to sex hormones, further diversifying its therapeutic offerings. The manufacturer quality system is fully aligned with international regulations and standards, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), as well as guidelines from the European Medicines Agency (EMA) and the World Health Organization (WHO).

Manufacturer usually replies in 4 days

DEXKETOPROFEN

Dexketoprofen provides short-term relief in painful conditions such as muscle sprains and strains, menstrual pain, toothache, migraines, knee pain and other short-term treatment of mild to moderate pain including dysmenorrhoea. Dexketoprofen, like other anti-inflammatory painkillers, is non-steroidal anti-inflammatory drugs (NSAIDs), or sometimes as 'anti-inflammatories'. It is the dextrorotatory stereoisomer of Ketoprofen. It is an anti-steroidal anti-inflammatory drug and has analgesic, antipyretic and int-inflammatory properties. Menarini manufactures Dexketoprofen under the brand name Keral. It is also available in Italy and Spain as an over-the-counter drug (OTC) under the trade name Enantyum besides in Latvia, Lithuania, and Estonia as an OTC under the tradename Dolmen. In Mexico, it is available in tablet form as "Stadium" made by Menarini. Dexketoprofen is sold under the brand name Keral, Enantyum, Dolmen and Stadium, amongst several other names.

Usage and Dosage:

In the Prophylaxis of organ rejection in patients who have received an allogeneic liver, kidney, or heart transplants, Dexketoprofen is often used in conjunction with adrenal corticosteroids or azathioprine or mycophenolate mofetil. The usual adult dose of Dexketoprofen does not exceed 25 mg per day by either taking half a 25 mg tablet every 4-6 hours, or one 25 mg tablet every eight hours. The patient must keep the duration of the therapy limited the immediate relief from pain. Depending on the nature and severity of pain, the recommended dosage for Adults is generally 12.5 mg, taken every 4-6 hours or 25 mg, taken every 8 hours. The total daily dose should not exceed 75 mg.

The price of Dexketoprofen:

In India, the price of three different brands of OTC drug cost between $0.4 to $2 and the wholesale price of Dexketoprofen Trometamol Powder is $30. The global bulk prices of this ingredient are between $170 and $320.

How it works:

Dexketoprofen actions block the effect of natural chemicals called cyclo-oxygenase, which helps to make other chemicals in the body, called prostaglandins. Prostaglandins are produced at sites of injury and cause pain or inflammation. Some of these prostaglandins are created by blocking the effect of COX enzymes, resulting in an easing of pain. All non-steroidal anti-inflammatory drugs reduce prostaglandin synthesis by the inhibition of the cyclooxygenase pathway. Synthesis of prostaglandins affects other inflammation mediators like kinins, alleviating pain.

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