"The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Fingolimod capsules 0.5 mg," Cadila Healthcare said in a filing to BSE.
The drug will be produced at the group's formulations manufacturing facility at pharma SEZ in Ahmedabad, it added.
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The product is mainly used for treating multiple sclerosis, Cadila said.
The group now has over 120 approvals and has so far filed more than 300 Abbreviated New Drug Applications (ANDAs), it added.
Shares of Cadila Healthcare today closed at Rs 532.50 per scrip on BSE, up 2.68 per cent from its previous close.