Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used in treating hypertension. Felodipine is the generic name for the brand Plendil®, marketed in the United States by Astra Zeneca. Wockhardt is launching the product immediately.
According to IMS Health, the total market for this product in the US was over $66 million. Hypertension and related cardiac diseases remain a major health concern the world over.
“We have received four ANDA approvals in the last 5 days and two of these are extended release pharmaceutical formulations,” said Dr. Habil Khorakiwala, Wockhardt Founder Chairman & Group CEO. “This definitely is a reflection of Wockhardt’s R&D prowess in indigenously developing such products,” he further added.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the few players to market technically challenging products has reaped the advantage of being an early entrant.
Wockhardt will be manufacturing the Felodipine API in its facility at Ankleshwar, India and the tablets of Felodipine ER at its facility in Aurangabad, India. The technology for the API and the extended-release tables were developed in-house.
Wockhardt is a high-technology intensive global pharmaceutical and biotechnology company with multi-disciplinary and innovative R&D programmes. It has 3 research centres globally and manufacturing facilities across India, USA, UK and Ireland. Wockhardt has a significant presence in USA, Europe and India, with 75% of its global revenues coming from international businesses. With a large pool of Patents and Intellectual Property knowhow, Wockhardt is home to 578 scientists, of whom 80 are doctorates. In all, Wockhardt has 164 Patents granted worldwide. In biotechnology research, it has built a competent ‘Concept to Market’ capabilities in all facets of development and manufacture of recombinant biopharmaceuticals. Wockhardt boasts of a multi-ethnic workforce of more than 7,900 people from 21 different nationalities.