Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules

Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for its generic Nitrofurantoin capsules indicated for the treatment of urinary tract infections. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Nitrofurantoin capsules, USP in the strengths of 25 mg, 50 mg and 100 mg, Alembic Pharma said in a regulatory filing.

The product is a generic version of Alvogen Malta Operations Ltd's Macrodantin capsules in the same strengths, it added.

According to IQVIA, Nitrofurantoin capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market size of USD 23 million for the twelve months ending March 2021, Alembic Pharma said.


Nitrofurantoin capsules, 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, it added.

The company has a cumulative total of 146 abbreviated new drug application (ANDA) approvals (128 final approvals and 18 tentative approvals) from USFDA, the filing said.

Shares of Alembic Pharmaceuticals were trading at Rs 982.40 apiece on BSE, down 0.12 per cent from its previous close.