Lupin Ltd received US Food & Drug Administration's approval for its abbreviated new drug application for Cefuroxime Axetil tablets.
The approvals were received for 250 mg and 500 mg tablets, for which the company has entered into an agreement with Watson Pharmaceuticals Inc for marketing it in the United States, a Lupin release said in Mumbai on Monday.
This is the first ANDA approval for Lupin in the US market, it said adding the company would manufacture the products at Mandideep, near Bhopal.
The company also estimates the market size of "Cefruxime Axetil", a broad-spectrum cephalosporin antibiotic for oral administration, to be at $310 million, it said.
The product patent for the amorphous form of "Cefuroxime Axetil" will expire on Tuesday, the release added.