Lupin unveils generic equivalent of Prograf Capsules
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin's alliance partner Concord Biotech Limited received an approval for the company's Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (USFDA).
Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, are the generic equivalent of Prograf Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, Inc.
The product is indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in pediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants.
Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf) had an annual sales of approximately USD 303 million in the U.S. (IQVIA MAT September 2020).
The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.