Lupin Gets U.S. FDA Nod For Generic Immunosuppressant Capsules
An employee collects packs of tablets as they move along the production line inside the packaging unit at the Lupin Ltd. pharmaceutical plant in Salcette, Goa. (Photographer: Dhiraj Singh/Bloomberg)

Lupin Gets U.S. FDA Nod For Generic Immunosuppressant Capsules

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Drug firm Lupin Ltd. on Thursday said that in alliance with Concord Biotech, it has received approval from the U.S. health regulator to market generic immunosuppressant Tacrolimus capsules used in the American market.

In alliance with Concord Biotech, the company has received approval from the United States Food and Drug Administration to market Tacrolimus capsules USP, in the strengths of 0.5 mg, 1 mg, and 5 mg, Lupin said in a filing to the BSE.

The product is a generic version of Astellas Pharma US, Inc's Prograf capsules in the same strengths, it added.

According to IQVIA MAT September 2020 data, Tacrolimus capsules USP (0.5 mg, 1 mg, and 5 mg) had an annual sales of about $303 million in the U.S., Lupin said.

The capsules are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants, it added.

Shares of Lupin Ltd on Thursday fell 1.76% to Rs 897.70 per scrip on the BSE.

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