Sun Pharma announces US FDA approval for generic Cymbalta®

Sun Pharmaceutical Industries Ltd. 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces US FDA approval for generic Cymbalta® Mumbai, December 12, 2013: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) today announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta ®, Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg. Duloxetine Delayed-Release Capsules USP, 20 mg, 30 mg and 60 mg are therapeutic equivalents of Eli Lilly & Company’s Cymbalta® Delayed-Release Capsules. These Capsules have annual sales of approximately USD 5.5 billion in the US. Duloxetine Delayed-Release Ca psules USP are indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD) and diabetic peripheral neuropathic pain (DPNP). Sun Pharma’s subsidiary, being one of the first-to-file ANDAs for generic Cymbalta® with a para IV certification, is eligible for shared 180-day marketing exclusivity in the US. Cymbalta® is a registered trademark of Eli Lilly & Company, Inc. About Sun Pharma Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an inte rnational specialty pharmaceut ical company with over 70% sales from global markets. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in US, India and several other markets acro ss the world. For the year ending March 2013, overall revenues were at US$2.1 billion, of which US contri buted US$1.1 billion. In India, the compan y is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex dosage forms. More information about the company can be found at www.sunpharma.com. Contacts Nimish Desai Mira Desai Tel +91 22 6645 5645, Xtn 5717 Tel +91 22 6645 5645, Xtn 5606 Tel Direct +91 22 6645 5717 Tel Direct +91 22 6645 5606 Mobile +91-98203 30182 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]

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