Lupin gets FDA approval for generic Nitrofurantoin Capsules USP

Nitrofurantoin Capsules USP (Macrocrystals), 50mg and 100mg, had annual sales of approximately $27mn in the US (IQVIA MAT April 2018).

Jul 12, 2018 07:07 IST India Infoline News Service

Pharma major Lupin announced that it has received final USFDA approval to market Nitrofurantoin capsules USP (Macrocrystals), 50mg and 100mg, the generic version of Alvogen's Macrodantin capsules, 50 mg and 100 mg.

It is indicated for the treatment of urinary tract infections due to susceptible strains of Escherichia coli (E. coli), enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.

Nitrofurantoin capsules had annual sales of approximately $27mn in the US (IQVIA MAT April 2018).

Lupin share price is currently at Rs892.65, down Rs8.45, or 0.94%, from its previous close of Rs901.10 on the BSE. The scrip opened at Rs900.05 and has touched a high and low of Rs909 and Rs897.80, respectively.

Lupin is a manufacturer of branded and generic formulations, biotechnology products and APIs. The company generated 38% revenue from US business, 27% from India, 17% from APAC, 7% from EMEA (Europe, Middle-East, and Africa), 5% from LATAM and ROW markets, and 1% from API in FY18.

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