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FDA Approves Docefrez

Sun Pharma Announces US FDA Approval for Docefrez (docetaxel) for Injection

Mumbai, May 4, 2011: Sun Pharmaceutical Industries Ltd. announced that US FDA has granted its subsidiary an approval for its New Drug Application (NDA) for Docefrez (docetaxel) for Injection, 20 mg/vial and 80 mg/vial.

This NDA provides for the use of Docefrez (docetaxel) for Injection, 20 mg/vial and 80 mg/vial for locally advanced or metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and hormone refractory metastatic prostate cancer.

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.

Contacts Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail uday.baldota@sunpharma.com E mail mira.desai@sunpharma.com

Posted: May 2011

Docefrez (docetaxel) FDA Approval History

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