Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg

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PTI | Mumbai | Updated: 28-01-2021 11:45 IST | Created: 28-01-2021 11:36 IST
Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg
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Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo®1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo® Tablets, 5 mg, and 10 mg market2 achieved annual sales of approximately $21.5 million*.

Glenmark's current portfolio consists of 168 products authorized for distribution in the U.S. marketplace and 43 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.

References:1 All brand names and trademarks are the property of their respective owners.

2 Market includes brand and all available therapeutic equivalents* IQVIATM National Sales Perspectives: Retail & Non-Retail, November 2020About Glenmark Pharmaceuticals LtdGlenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with a presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top-ranked companies in terms of Corporate Sustainability within each industry are featured in the index.

 

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