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Sun Pharmaceutical Industries Ltd Announces US FDA Approval for Generic Cardizem CD(R)


10/31/2011 7:56:49 AM

Mumbai, October 31, 2011: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cardizem CD®, Diltiazem HCl extended-release capsules.

These generic Diltiazem HCl extended-release capsules, are equivalent to Valeant International's, Cardizem CD®, 120 mg, 180 mg, 240 mg, 300 mg and 360 mg. Annual sale in the US for these strengths is approximately $ 300 million.

Diltiazem HCl extended-release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm.

Cardizem CD® is a registered trademark of Valeant International.

About Sun Pharmaceutical Industries Ltd. ]

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.




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