Alembic Pharmaceuticals announces USFDA Final Approval for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), 'Macrodantin Capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations Ltd. Nitrofurantoin capsules, USP (Macrocrystals) 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), 25 mg, 50 mg and 100 mg have an estimated market size of US$ 23 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 146 ANDA approvals (128 final approvals and 18 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.985.65 as compared to the previous close of Rs. 987.6. The total number of shares traded during the day was 12230 in over 1076 trades.

The stock hit an intraday high of Rs. 994.6 and intraday low of 982.05. The net turnover during the day was Rs. 12079754.

Source : Equity Bulls

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