Unichem Laboratories bags USFDA approval for generic version of Dilantin; stock zooms ~2%

14 Oct 2022 , 11:30 AM

Unichem Laboratories Limited announced that it has received ANDA approval from the United States Food and Drug Administration (USFDA) 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.

At around 11.33 AM, Unichem Laboratories was trading at Rs367.15 up by 1.72% from its previous closing of Rs360.95 on the BSE. The scrip opened at Rs366.90 and touched intraday high and low of Rs370.10 and Rs364.75 respectively.

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