Company Watch

Lupin gets USFDA nod for Cephalexin capsules

Our News Bureau - Mumbai

Lupin has received USFDA approval for its ANDA for Cephalexin capsules USP 250 mg and 500 mg. The US market for Cephalexin capsules is estimated at $80 million.

This is Lupin's eighth ANDA approval by the USFDA till date and the third in this financial year. Earlier this year, the company had received approvals from USFDA for Lisinopril tablets and Cephalexin for oral suspension. This approval makes Lupin 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 and streptococci; bone infections caused by staphylococci and P. mirabilis and genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae.