Glenmark Pharmaceuticals Receives ANDA Approval For Fenofibrate Capsules


On Monday, Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fenofibrate Capsules USP, 67 mg, 134 mg and 200 mg, the generic version of Tricor® Micronized Capsules, 67 mg, 134 mg, and 200 mg of AbbVie, Inc.

According to IMS Health sales data for the 12-month period ending February 2017, the Tricor® Micronized Capsules, 67 mg, 134 mg and 200 mg market1 achieved annual sales of approximately $97.5 million*.

Glenmark’s current portfolio consists of 114 products authorized for distribution in the U.S. marketplace and approximately 64 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.

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