The approval is for Cephalexin capsules of 250 mg and 500 mg, the company informed the Bombay Stock Exchange.
The US market for Cephalexin Capsules is estimated at $80 million, it said. This is the company'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 the US FDA for Lisinopril tablets and Cephalexin for Oral Suspension, it added.
Cephalexin is indicated for the treatment of respiratory tract infections, skin and skin structure infections, bone infections and genitourinary tract infections, it said.