Unichem Laboratories Limited has received ANDA approval for its Extended Phenytoin Sodium Capsules USP, 100 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Dilantin (Phenytoin Sodium) Capsules, 100 mg, of Viatris Specialty LLC.

Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. The product will be commercialized from Unichem’s Ghaziabad Plant.

Unichem Laboratories Limited, an international, integrated, specialty pharmaceutical company, manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world. In India,

The company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.