18 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Pharmaceutical and biotechnology major Wockhardt received final approval from the US FDA for marketing 15mg and 30mg delayed release capsules of Lansoprazole, which is used in treatment of peptic ulcers. Lansoprazole is the generic name for the brand Prevacid, marketed in the US by Takeda. Wockhardt is launching the product immediately.
Wockhardt will be manufacturing the Lansoprazole API in its facility at Ankleshwar, India, and the delayed release capsules of Lansoprazole at its facility in Aurangabad, India. The technology for the API and the capsules were developed in-house.
Dr Habil Khorakiwala, founder chairman and group CEO, Wockhardt, said that, "Lansoprazole delayed release formulation is a verychallenging product and it once again demonstrates Wockhardt R&D's capability in the NDDS technology space. We have received eight ANDA approvals in the past 30 days and four of them have been products that involved significant echnology in formulation."
According to IMS Health, the total market for this product in the US is about $700 million. Proton pump inhibitors like Lansoprazole are the mainstay of treating ulcers worldwide. Wockhardt already markets an over-the-counter version of 15mg Lansoprazole capsules in the US.