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Country of origin : Turkey

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idebenone

Tablets, film coated 45 mg, 90 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Manufacturer #32131
This company specializes in the production of high-technology pharmaceutical and medical products across multiple therapy areas. Their extensive product portfolio includes prescription medications, over-the-counter drugs, medical devices, and supplements, available in a variety of dosage forms. They operate a fully integrated production base adhering to strict GMP certifications and hold patents for their innovative products. The company serves key regions including the EU and North America, demonstrating a strong track record and experience in the global healthcare market.

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IDEBENONE

Idebenone is used in the treatment and manages Alzheimer's, Huntington’s, liver, and heart diseases. It also treats some inherited disorders including Leber’s hereditary optic neuropathy, mitochondrial encephalomyopathies that involve nerve and muscle disorders, Duchenne muscular dystrophy, and Friedreich's ataxia, a nervous system disorder producing gait and speech problems, and eventually leading toward heart disease and diabetes. Idebenone is similar to coenzyme Q-10 and a man-made product. Idebenone is sold under brand names Catena, Raxone, Sovrima, among others. Takeda Pharmaceutical Company initially developed it for the treatment of Alzheimer's disease and other cognitive defects but met with limited success. Later, Santhera Pharmaceuticals, a Swiss co investigated it for the treatment of neuromuscular diseases. In 2010, It was tested for Friedreich's ataxia and Duchenne muscular dystrophy but it was not approved for the above in North America or Europe. In 2007, Idebenone was approved by the European Medicines Agency for use in Leber's hereditary optic neuropathy and received its designation as an orphan drug.

Dosage and administration

Idebenone is sold as tablets in 300mg strength and taken orally. In the treatment of Alzheimer's disease, the recommended initial adult dose is 90-120 mg, taken three times a day. In treating inherited Leber's hereditary optic neuropathy, the dose is 300 mg, taken orally three times per day with meals for both children and adults. In children, in the treatment of Duchenne muscular dystrophy, the dose is 900 mg, taken daily for one year.

The price of Idebenone

In the international market, a supply of 20mg of for the ingredient form costs around USD 247. In India, the consumers have to pay a retail price of USD 2.8 for a supply of 10 tablets of 45mg strength.

How does it work?

Idebenone has several actions, some of the actions include stimulation of ATP formation, increasing the antioxidant capacity, scavenging the free radicals, protecting against lipid peroxidation. It also bypasses the dysfunctional complex I of the mitochondrial respiratory chain.

Finding Idebenone Manufacturers and Suppliers:

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