Wockhardt gets USFDA approval to market generic Protonix

Drug firm Wockhardt today said it has received final approval from the US health regulator -- US Food and Drug Administration to market generic pantoprazole tablets, used for treating ulcers and hyperacidity, in the American market.

The company has launched the tablets in the strengths of 20 mg and 40 mg in the US market as the patent covering the product expired on January 19, 2010, Wockhardt said in a filing to the Bombay Stock Exchange (BSE).

The company's pantoprazole tablets are generic equivalent of Protonix, which is marketed by Pfizer in the US market.

"This is yet another product that Wockhardt has been able to launch on the date of the patent expiry," Wockhardt Chairman Habil Khorakiwala said.

He further added, "The ability to launch products on the date of patent expiry is a critical requirement to create maximum value and over the years, Wockhardt has been able to reinforce this capacity on several occasions."

The company will manufacture the generic tablets at its US Food and Drug Administration's certified plant at Waluj, Maharashtra.

The Mumbai-based firm also said it will manufacture pantoprazole active pharmaceutical ingredients (API) at its plant at Ankleshwar in Gujarat.

According to information services company Wolters Kluwerm , the total market for pantoprazole in the American market is nearly $ 2 billion.

Shares of Wockhardt today closed at Rs 366.50 on the BSE, up 4.45 per cent from its previous close.

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