Glenmark receives ANDA approval for Tacrolimus caps
Tacrolimus capsule is used for preventing organ rejection in certain patients following liver, kidney, or heart transplant
Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf 1 capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc. Tacrolimus capsule is an immunosuppressant and is used for preventing organ rejection in certain patients following liver, kidney, or heart transplant.
According to IQVIATM sales data for the 12 month period ending September 2020, the Prograf Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately $286.8 million.
Glenmark’s current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
PTI