Wockhardt has received one final and one tentative US FDA approval for generic version of Plendil and Geodaon respectively. The company is launching extended-release tablets containing 2.5 mg, 5 mg, and 10 mg felodipine, the generic name of the brand Plendil of AstraZeneca for treating hypertension with final US FDA approval.
Further, Wockhardt is planning to launch generic version of 20 mg, 40 mg, 60 mg and 80 mg capsules containing ziprasidone hydrochloride for the treatment of bipolar disorders and schizophrenia from September 2, 2012. Ziprasiodne capsule is the generic name of Pfizer's brand Geodon. Dr Habil Khorakiwala, founder chairman and Group CEO said, “This is the fifth US FDA approval for Wockhard in the past 8 days. Wockhardt's R&D has ensured a steady stream of new products, which has translated into a varied product offering in the US market.”
According to IMS Health, the total market for Plendil 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, 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 and ziprasidone HCI API in its facility at Ankleshwar, India and the tablets of felodipine ER and the capsules at its facility in Aurangabad, India. The technology for the API and the extended-release tables were developed in-house.