Wockhardt Ltd has announced that the company has received US FDA approval for antibiotic cefprozil tablets 250 mg and 500 mg and is all set to launch the product in the US market.
Cefprozil, a Cephalosporin class of antibiotics, is used in the treatment of respiratory tract and skin infections. The company will launch cefprozil, the generic version of brand Cefzil, sold by Bristol Myers Squibb.
"Several of our products have seen a dramatic increase in market share in the US, over the last six months. Cephalosporins have been an important product in our portfolio and cefprozil will be a good addition to this range with a market potential of around $51 million", said the company's chairman Habil Khorakiwala. "The eight FDA approval in just four months will significantly contribute to our growing visibility in USA", added Habil Khorakiwala.
The cefprozil tablets are manufactured at the company's US FDA, certified formulation plant at Waluj, Maharashtra. The product was developed in-house.
The company is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API's, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.