omega 3 fatty acids Tablets TBD

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Brazil
Manufacturer #441

Manufacturer usually replies in nan days

Omega−3 fatty acids

Omega 3 fatty acids are lipid-regulating agents. They are an adjunct to diet to reduce triglyceride levels in adult patients with severe, that is more than 500 mg/dL or greater, hypertriglyceridemia. Ingestion of omega-3 PUFAs, abundant in fish oils, have potent actions on several human disorders and diseases, including cardiovascular disease and cancer. they reduce platelet activity, contributing to their potential cardiovascular benefits. Fish oil lowers high triglyceride levels reducing the risk for heart disease and stroke. It also curbs stiffness and joint pain in addition to boosting the effectiveness of anti-inflammatory drugs. It also plays a role in important in visual and neurological development in infants. A diet rich in omega-3s lowers inflammation, helping asthma patients heal and recover better. Some studies have also shown that they can help in reducing symptoms of ADHD and Alzheimer’s and Dementia. Omega−3 fatty acids are sold under the brand names Vascepa in the USA and Epadel among others. Efamol Holdings Plc filed the first patents for treating schizophrenia using essential fatty acid compositions in 1988, since then several companies have made formulations for the treatment of other conditions. In 2004, the FDA gave EPA and DHA omega−3 fatty acids, a "qualified health claim" status, but said it has "supportive but not conclusive research shows that consumption of EPA and DHA [omega−3] fatty acids may reduce the risk of coronary heart disease’.

Dosage and administration

Omega−3 fatty acids are sold in Japan as capsules in 300mg, 600mg to 900mg strength capsules for oral administration. The usual dose is 1.8 g per day and can be increased to 2.7g a day if TG levels remain abnormal. IT can be taken two or three times daily after meals to achieve the desired daily dose. In the USA, the brand available in 500-mg and 1000-mg capsules at a dose of 4 g a day, to be taken orally as two 1000-mg capsules, or four 500-mg capsules, twice daily with meals.

The price of Omega−3 fatty acids

In the international market, the consumers have to pay a retail price of $208.22. for the supply of 120 capsules of 1g strength. In India, the consumers have to pay the retail price of USD 9 for a supply of 225grms of 1000mg strength.

How does it work?

They are characterized by the presence of a double bond three atoms away from the terminal methyl group in their chemical structure. Omega-3 fatty acids help in reducing the risk of heart disease. In combination with diet and exercise, it lowers levels of certain blood fat, (bad) and raises levels of "good" cholesterol, called HDL. Omega-3 fatty acids are eicosapentaenoic acid, alpha-linolenic acid, and docosahexaenoic acid. ALA is found in plant oils such as flaxseed, soybean, and canola oils. DHA and EPA are occurring naturally in fish and other seafood. Omega−3 fatty acids, also called Omega-3 oils are polyunsaturated fatty acids.

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