Zydus Cadila gets US regulator nod to commercialise Fingolimod capsules

Indian pharmaceutical major, Zydus Cadila announced that it has received approval from United States Food & Drug Administration (USFDA) to market Fingolimod capsules in the strength of 0.25 mg.  

Fingolimod is a sphingosine 1-phosphate receptor modulator used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations as well as to delay physical disability. Earlier, in October 2020, the Group was granted approval to market Fingolimod capsules in the strength of 0.5 mg.   

The abovementioned drug in the strengths of 0.25 mg will be manufactured at the Group’s formulation manufacturing facility located at Special Economic Zone (SEZ), Ahmedabad. As of now, Cadila has 319 approvals and filed over 400 ANDAs.    

At 1.33 pm on Thursday, the stock of Cadila Healthcare was trading at Rs 619.90, down by 0.71 per cent or 4.45 per share as against a 0.72 per cent gain in the benchmark index.  The 52-week high and 52-week low of the scrip was recorded at Rs 673.70 and Rs 347.05, respectively on BSE.