Nicardipine is the generic name for the brand Cardene,which is used for short-term management of hypertension or increased blood pressure.

Wockhardt, Pharmaceutical and biotechnology major launches anti-hypertensive drug Nicardipine injections in USA. Wockhardt announced that company has received United States Food & Drug Administration (US FDA) final approval for marketing Nicardipine HCl 25mg/10 ml injection, which is used for short-term management of hypertension or increased blood pressure.

Nicardipine is the generic name for the brand Cardene, marketed in the United States by EKR Therapeutics. The patents covering this product expired on Nov 17, 2009 and Wockhardt is launching the product immediately.

 “The injections and other sterile products form an integral part of Wockhardt’s growth strategy in the United States,” said Wockhardt Chairman Habil Khorakiwala. “This is our seventeenth sterile product approval in the US based on a variety of technologies like liquid injections in vials and pre-filled syringes, powder for injection and ophthalmic solutions. Being backward integrated into the Nicardipine API will also help us gain competitive advantage.”

According to IMS, the total market for Nicardipine injection in the US is over $200 million and is one of the few drugs that are used in injectable form to control hypertension in patients who are unable to receive oral medications.

The Nicardipine injections will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad and it will use API, which is also being manufactured by Wockhardt in its FDA approved plant at Ankleshwar. Both the API and the injections were developed in-house. Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.

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