Alembic Pharmaceuticals announces USFDA final approval for Nitrofurantoin capsules

Alembic Pharmaceuticals Limited today announced that it has received final approval from US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Nitrofurantoin capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg.   

The drug is equivalent to the reference listed drug product (RLD), Macrodantin capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations Limited. Nitrofurantoin capsules, USP (Macrocrystals) is used for the treatment of urinary tract infections.  

Reacting to this, the company’s stock today increased by 0.63 per cent and made an intraday high of Rs 989.75 per share.  

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

Alembic Pharmaceuticals is in the business of development, manufacturing & marketing of pharmaceuticals products i.e. formulations and active pharmaceutical ingredients. The company has three R&D and five manufacturing facilities.  

According to BSE data, the stock traded at a P/E multiple of 16.45 and a price-to-book ratio of 3.68. The stock has a 52-week high and a 52-week low of Rs 1,150 and Rs 863.55, respectively.  

At 2.35 pm, the stock of the company was trading at Rs 982.80, down by 0.08 per cent on BSE.