Lupin Ltd has received US FDA approval for its abbreviated new drug application (ANDA) for cephalexin capsules USP 250 mg and 500 mg. The US market for cephalexin capsules is estimated at USD 80 million.

According to the company release, this is Lupin's eighth ANDA approval by the US FDA till date and the third in this financial year. Earlier this year, the company had received approvals from the US FDA for lisinopril tablets and cephalexin for oral suspension. The approval makes company one of the select few integrated players who offer both cephalexin capsules and suspension in the US market.

A main stay cephalosporin antibiotic, cephalexin is indicated for the treatment of respiratory tract infections caused by S.pneumoniae and S.pyogenes, skin and skin structure infections caused by staphylococci or streptococci. Bone infections caused by staphylococci or P. mirabilis and genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis and K. pneumonia.