Drug firm Wockhardt said it has received approval from American health regulator to market Lansoprazole, a drug used in treatment of ulcers, in the US market.
The company has received final approval from the US Food and Drug Administration (USFDA) to market Lansoprazole in the American market in strengths of 15 mg and 30 mg, Wockhardt said in a statement.
“Lansoprazole delayed release formulation is a very challenging product and it once again demonstrates Wockhardt R&D’s capability in the NDDS technology space,” Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
Lansoprazole is the generic name for the brand Prevacid, marketed in the United States by Takeda. “Wockhardt is launching the product immediately,” the company added. According to IMS Health sales data, the total market for the product in the US is about $700 million. Wockhardt already markets an over-the counter version of 15 mg Lansoprazole DR capsules in the US.
“Wockhardt will be manufacturing the Lansoprazole active pharmaceutical ingredient (API) in its facility at Ankleshwar, India and the delayed-release capsules of Lansoprazole at its facility in Aurangabad,” the company said. Wockhardt scrip was trading at Rs 1,280 on the BSE.