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oxcarbazepine Tablets 150 mg, 300 mg, 600 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
FDA, EU GMP
Comments
Ref. Trileptal
Manufacturer #31058

This company, based in Europe, is a pharmaceutical manufacturer with a history spanning over seven decades. They focus on the development, production, and marketing of generic and value-added medicines, catering to patients globally. Their expertise lies in complex generics and their portfolio includes prescription drugs and over-the-counter medications. They hold significant experience in the industry, with strong manufacturing capabilities in Europe and North America, backed by GMP certifications. The company has a robust track record of growth, demonstrated by its international presence and expansion into key regions such as Europe and North America. Key therapy areas include cardiovascular, oncology, and gastrointestinal disorders. Their production lines include solid dosage forms, injectables, and liquids.

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Oxcarbazepine Manufacturers

Oxcarbazepine is a potent anticonvulsant drug used alone or in combination with other drugs in the treatment of partial seizures. Oxcarbazepine belongs to a class of drugs called anticonvulsants. Oxcarbazepine is advised as a prescription product as well as generic prescription product. Manufacturers market Oxcarbazepine drug under the Brand name of Trileptal, Oxtellar XR. Trileptal brand of oxcarbazepine is used as monotherapy (alone) or adjunctive therapy in the treatment of partial seizures in adults and as a single drug in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as combination with other drugs in pediatric patients aged 2 years and above with partial seizures. Oxtellar XR brand of oxcarbazepine is used with other medicines in adults and children who are at least 6 years old. Oxcarbazepine comes in a dosage form of tablet (film coated) and suspension which are administered orally. Oxcarbazepine tablet is available in dosage strength of 150 mg, 300 mg, 600 mg and suspension form is available in 300 mg/5 mL (60 mg/mL). Oxcarbazepine tablet can be taken with or without food. Each film coated tablet is in oval shape, slightly biconvex and engraved on both the sides. Bottle containing oxcarbazepine suspension, has to shake well and the dose should be immediately prepared. The required amount of oral suspension should be withdrawn from the bottle using the oral dosing device supplied with the bottle. Oral suspension can be mixed in a small glass of water before administration or can be swallowed directly from the device. The recommended adult daily dose is 1200 mg/day, and in pediatrics, the recommended daily dose is dependent upon patient weight. The approved storage conditions for Oxcarbazepine is to store at a temperature of 25° C (77° F). Excursions permitted to 15° C - 30° C (59° F - 86° F).

Wholesale Price of Oxcarbazepine

In US market, the cost for oxcarbazepine oral suspension 300 mg/5 mL (60 mg/mL) is around $ 64 for a supply of 150 milliliters. The wholesale price of 150 mg oxcarbazepine oral tablet costs around $ 33.88 for a set of 100 tablets and per unit / tablet cost as $ 0.34. For a set of 500 tablets the price range is $ 128.91 - $ 303.74 with per unit cost as low as $ 0.26 The wholesale price of 300 mg oxcarbazepine oral tablet costs around $ 50.77 for a set of 100 tablets and per unit / tablet comes at $ 0.51 The wholesale price of 600 mg oxcarbazepine oral tablet costs around $ 81.61 for a set of 100 tablets and per unit / tablet costs at $ 0.82

Oxcarbazepine - Mechanism of Action

Oxcarbazepine is a prodrug and is converted to its active metabolite, monohydroxy (MHD). Oxcarbazepine and MHD inhibits seizure activity by binding to the inactive site of sodium channel, this helps in stabilization of neuronal membranes and prevent the spread of seizure activity within central nervous system without affecting normal neuronal transmission.

Finding Oxcarbazepine Manufacturers and Suppliers

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