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Country of origin : Bosnia-and-herzegovina

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1 products found

ketoprofen

Capsules 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bosnia And Herzegovina
GMP approvals
EU GMP
Comments
Indication - rheumatic and musculoskeletal disorders, dysmenorrhoea and other painful conditions
Manufacturer #21530

The company 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).

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KETOPROFEN

Ketoprofen is a propionic acid of a non-steroidal anti-inflammatory drug. It treats renal colic, muscular pain and moderately severe migraine attacks. Ketoprofen is also highly preferred in the treatment of chronic pain in patients with osteoarthritis, rheumatoid arthritis and management of acute forms of pain, traumatic and post-surgical pain and primary dysmenorrhea. It has analgesic and antipyretic effects. It works by inhibiting body’s production of prostaglandin. Ketoprofen is sold under the Brand names Orudis ,Oruvail Ketoflam amongst others. Rhône-Poulenc chemists were the first to synthesize it in 1967, and introduced in 1973 in France and the United Kingdom as an antiinflammatory drug. It was first approved for used in the USA in 1980.

Dosage:

Ketoprofen is available as immediate and extended release capsules. For quick relief from symptoms of Rheumatoid Arthritis, the patient is recommended to take immediate release oral capsule of 50mg or 75mg and if taking extended release oral capsule, the recommended dose is 200mg. The Typical dosage for immediate release capsule is 75 mg taken 3 times per day, or 50 mg taken 4 times per day with daily Maximum dosage capped at 300 mg. the typical dose of Extended-release capsule is 200 mg taken once per day. In the treatment of Osteoarthritis, immediate-release oral capsule of Strengths or 50 mg, 75 mg or extended-release oral capsule of 200 mg Strength is prescribed. The dose for relief from pain and menstrual pain is same as the above The price of Ketoprofen: In the USA, As of 2015, the consumers were paying between US is $50 to $100 for a month’s supply. This price is significantly lower in the developing world. The same monthly supply of 90 tablets of 50 mg or 100 mg cost between USD2 and USD5 in India.

How does Ketoprofen work?

Ketoprofen works by selectively inhibiting isoform-I of cyclo-oxygenase, COX-1. Its salification with lysine aminoacid enables rapid onset of action. Its actions decrease the hormones that cause inflammation and pain in the body caused by inflammation. It mixes with cyclooxygenases and thereby prevents its substrate-enzyme combination with arachidonic acid and the formation of icosanoids, prostaglandins, and thromboxanes. In combination with lipoxygenase, its actions prevents the substrate-enzyme combining with arachidonic acid and the formation of the icosanoid products like leukotrienes. It’s primary actions are antipyretic and anti-inflammatory.

Finding Ketoprofen Manufacturers and Ketoprofen Suppliers

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