MUMBAI: Lupin Ltd has announced that it has received US Food and Drug Administration (USFDA) 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 $80 million.
This is the company's eighth ANDA approval by the USFDA so far and the third in this financial year.
Earlier this year, the company had received approvals from the USFDA for Lisinopril tablets and Cephalexin for oral suspension.
"The approval makes the company one of the select few integrated players who offer both Cephalexin capsules and suspension in the US market," Lupin said in a notice to the BSE.
A main stay cephalosporin antibiotic, Cephalexin is indicated for the treatment of respiratory tract infections.