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Lupin gets tentative nod from US FDA for Silodosin Capsules

06 Sep 2016 Evaluate

Pharma Major Lupin’s has received tentative approval for its Silodosin Capsules 4 mg and 8 mg from the United States Food and Drug Administration (US FDA) to market a generic version of Allergan Sales, LLC's Rapaflo Capsules, 4 mg and 8 mg.

The company's Silodosin Capsules, 4 mg and 8 mg are the AB rated generic equivalent of Allergan Sales, LLC's Rapaflo Capsules, 4 mg and 8 mg. It is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. Rapaflo had US sales of $ 228.7 million.

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.

 

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Company Name CMP
Sun Pharma. Inds. 1810.00
Dr. Reddys Labs. 1200.10
Cipla 1346.85
Lupin 2029.00
Zydus Lifesciences 1145.25
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