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Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (US FDA) for its Extended Phenytoin Sodium Capsules USP, 100 mg to market a generic version of Viatris Specialty LLC's Dilantin (Phenytoin Sodium) Capsules, 100 mg.
Extended Phenytoin Sodium Capsules are used to treat tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures, as well as to prevent and treat seizures that develop during or after neurosurgery. Unichem's Ghaziabad plant will commercialise the product.
Unichem Laboratories is a speciality pharmaceutical company that operates on a global scale. It makes and sells a wide range of pharmaceutical formulations in a variety of markets across the world, both as branded generics and generics.
Unichem Labs bags ANDA approval from US FDA
Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (US FDA) for its Extended Phenytoin Sodium Capsules USP, 100 mg to market a generic version of Viatris Specialty LLC's Dilantin (Phenytoin Sodium) Capsules, 100 mg.
Extended Phenytoin Sodium Capsules are used to treat tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures, as well as to prevent and treat seizures that develop during or after neurosurgery. Unichem's Ghaziabad plant will commercialise the product.
Unichem Laboratories is a speciality pharmaceutical company that operates on a global scale. It makes and sells a wide range of pharmaceutical formulations in a variety of markets across the world, both as branded generics and generics.
More news about: quality / gmp | Published by Sudeep Soparkar | October - 17 - 2022 | 822
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