Glenmark Pharmaceuticals announced on Wednesday that it has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Tacrolimus Capsules USP, the generic version of Prograf® Capsules, of Astellas Pharm US.
The Mumbai based company stated in its BSE regulatory filing. “According to IQVIATM sales data for the 12 month period ending September 2020, the Prograf® Capsules, 0.5 mg, 1 mg and 5 mg market achieved annual sales of approximately $286.8 million*.”
“Glenmark’s current portfolio consists of 166 products authorized for distribution in the U.S.
marketplace and 45 ANDA’s pending approval with the U.S. 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.”
