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Lupin launches generic immunosuppressant drug in US

Its alliance partner Concord Biotech received approval from FDA

USFDA issues warning letter on Lupins Somerset facility, cites repeated violations at companys manufacturing facilities
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USFDA issues warning letter on Lupin's Somerset facility, cites repeated violations at company's manufacturing facilities

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New Delhi: Drug firm Lupin on Wednesday said it has launched generic immunosuppressant Tacrolimus capsules in the American market after its alliance partner Concord Biotech received an approval for the product from the US health regulator.

The company has launched Tacrolimus capsules USP in the strengths of 0.5 mg, 1 mg, and 5 mg, after Concord Biotech Ltd received an approval for its abbreviated new drug application (ANDA) from the United States Food and Drug Administration (USFDA), Lupin said in a regulatory filing. The capsules are generic versions of Astellas Pharma US Inc's Prograf capsules in the same strengths, it added. According to IQVIA MAT September 2020 data, Tacrolimus capsules USP of 0.5 mg, 1 mg, and 5 mg had annual sales of around $303 million in the US, Lupin said.

"The capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in paediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants," it added. Shares of Lupin Ltd were trading at Rs 902.05 per scrip on BSE, up 0.77 per cent from its previous close.

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