Lupin alliance partner Concord gets USFDA nod for Tacrolimus Capsules
Tacrolimus Capsules USP 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.
Mumbai, Baltimore: Pharma major, Lupin Limited in alliance with Concord Biotech Limited, has recently announced that the company has received approval from the United States Food and Drug Administration (USFDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg.
The product is a generic version of Prograf Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, Inc.
Tacrolimus Capsules USP 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.
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).
Read also: Lupin reports net profit at Rs 211 crore in Q2
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.
