Sun Pharma announces US FDA approval for generic Gleevec®

Sun Pharmaceutical Industries Ltd. SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India Tel.: (91-22) 4324 4324 Fax.: (91-22) 4324 4343 CIN: L24230GJ1993PLC019050 www.sunpharma.com Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : SUN HOUSE, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, India. FOR IMMEDIATE RELEASE Sun Pharma announces US FDA approval for generic Gleevec ® Company eligible for 180-days marketing exclusivity on a first-to-file Para-IV ANDA Mumbai, December 04, 2015: Sun Pharmaceutical Indus tries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharma) today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec ®, Imatinib Mesylate tablets 100mg and 400mg. Imatinib Mesylate tablets, 100 mg and 400 mg are th erapeutic equivalents of Novartis’ Gleevec ® tablets. As per IMS MAT August 2015, these tablets have annual sales of approximately US$ 2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia. The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec ® with a para IV certification, is eligible for 180-days marketing e xclusivity in the US. Under the terms of a settleme nt agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec ® in the United States on February 1, 2016. The comm ercial launch of this product is scheduled for February 1, 2016. Gleevec ® is the registered trademark of Novartis Pharmaceuticals Corporation. About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's fifth largest specialty g eneric pharmaceutical company and India's top pharm aceutical company. A vertically integrated business, economie s of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable p rices. It provides high-quality, affordable medicin es trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is support ed by 50 manufacturing facilities spread across 6 continents , R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. The consolidated revenues for 12 months ending March 2015 are approx imately US$ 4.5 billion, of which US contributes US$ 2.2 bi llion. In India, the company enjoys leadership acro ss 13 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footpr int across emerging markets covers over 100 markets and 6 mark ets in Western Europe. Its Global Consumer Healthca re business is ranked amongst Top 10 across 4 global m arkets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innov ation supported by strong R&D capabilities comprising abo ut 2,000 scientists and R&D investments of over 7% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live. Contacts Nimish Desai Frederick Castro Tel +91 22 4324 4324, Xtn 2778 Tel +91 22 4324 4324, Xtn 2777 Tel Dir ect +91 22 4324 2778 Tel Direct +91 22 4324 2777 Mobile +91 -98203 30182 Mobile +91 99206 65176 E mail [email protected] E mail [email protected]

The release as fetched from its publisher. sunpharma.com ↗