Alembic Pharma gets USFDA nod for generic Nitrofurantoin capsules

Live bsense Live Volume Todays L/H PlusAlembic Pharmaceuticals, a drug company, announced Thursday that it received approval from the US Health regulator for its generic Nitrofurantoin capsules for treatment of urinary tract infection.Alembic Pharma announced that the company received the final approval of the US Food & Drug Administration for its abbreviated drug application (ANDA), for Nitrofurantoin capsules. USP is available in three strengths: 25 mg, 50mg, and 100m.It is a generic version Alvogen Malta Operations Ltd’s Macrodantin capsules with the same strengths.Alembic Pharma stated that Nitrofurantoin capsules (USP) (Macrocrystals), 25mg, 50mg, and 100mg have an estimated market value of USD 23 millions for the 12 months ending March 2021.It is indicated to treat urinary tract infections caused by susceptible strains such as enterococci and staphylococcus aureus.According to the filing, the company has received 146 abbreviated drug application (ANDA), approvals from USFDA. This includes 18 tentative approvals and 128 final approvals.BSE saw shares of Alembic Pharmaceuticals trade at Rs 982.40 per share, a 0.12% decrease from its previous close.