Drug maker Lupin today said it has received approval from the U.S. health regulator to market its Suprax capsules, used for treating bacterial infections, in the American market.
The company’s subsidiary, Lupin Pharmaceuticals Inc, has received new drug application (NDA) approval from the United States Food and Drug Administration (USFDA) for Suprax (Cefixime) capsules in the strength of 400 mg, Lupin said in a statement.
The firm expects to commence shipping the product in the near future, it added.
Commenting on the development, Lupin Group President & ED Nilesh Gupta said: “The new dosage form will add to our growing Suprax franchise and gives healthcare providers and patients a new formulation to treat the indicated infections“.
The approval will expand Lupin’s range of Suprax dosage forms. The product is currently available as 100 mg/5ml, 200 mg/5ml suspensions and 400 mg tablets, the statement said.
Shares of Lupin Ltd were being quoted at Rs. 537 in the afternoon trade on the BSE today, up 0.74 per cent from previous close.