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news.Wockhardt has received final approval from the US Food and Drug Administration (FDA) to market Lansoprazole 15mg and 30mg delayed release capsules aimed to treat peptic ulcers.
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The company is planning an immediate release of the capsule in the US, which is being marketed under the brand name, Prevacid by Takeda.
Wockhardt founder chairman and group CEO Habil Khorakiwala said Lansoprazole delayed release formulation adds up to NDDS technology space.
"We have received eight ANDA approvals in the past 30-days and four of them have been products that involved significant technology in formulation," Khorakiwala added.
The total market for the product in the US is about $700m, according to IMS Health.
Wockhardt is already marketing 15mg Lansoprazole DR capsules in the US as an over-the-counter drug.
Wockhardt will manufacture Lansoprazole API and the Lansoprazole delayed-release capsules at its Ankleshwar and Aurangabad facilities in India respectively.