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news.Glenmark Generics Inc (GGI), the US subsidiary of Glenmark Generics Limited (GGL), have been granted final approval from the US Food and Drug Administration (FDA) for Felodipine extended-release tablets, the generic version of Astrazeneca Pharmaceuticals LP, Plendil.
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Glenmark‘s extended-release Felodipine tablets are available in strengths of 2.5 mg, 5 mg and 10 mg and are indicated for the treatment of hypertension.
Glenmark will commence marketing and distribution immediately in the US and anticipates a successful launch based on the limited competition existing in the market.
The company’s current portfolio consists of 63 generic products authorized for distribution in the US market, as well as over 40 ANDA’s filed with the FDA pending approval.
In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.