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Lupin receives FDA approval for Nitrofurantoin capsules

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Nitrofurantoin capsules a generic version of Alvogen Malta Operations’ Macrodantin Capsules, 50 mg and 100 mg

Lupin, an innovation led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally, has received final approval for its Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen Malta Operations’ Macrodantin Capsules, 50 mg and 100 mg.

Lupin’s Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg had annual sales of approximately USD 27 million in the US.

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