Sun Pharmaceutical announces USFDA approval to market generic Sinemet® tablets
Mumbai, November 5, 2008: Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715) announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market generic Sinemet®, carbidopa and levodopa tablets. These carbidopa and levodopa tablets are therapeutically equivalent to Sinemet® tablets from Bristol-Myers Squibb and are available in three strengths: 10 mg / 100 mg, 25 mg / 100 mg and 25 mg / 250 mg. These strengths of carbidopa and levodopa tablets, used in the treatment of Parkinson's disease and syndrome, have annual sales of approximately USD 70 million in the US.
Sinemet is a registered trademark of Merck & Co.
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.