drugset / Press release

Sun Pharma announces US FDA approval for generic Crestor®

2016-07-20 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗

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 Crestor ® Mumbai, July 20, 2016: Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and inclu des its subsidiaries or associate companies) 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 Cres tor ®, Rosuvastatin Calcium tablets 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base). These Rosuvastatin Calcium tablets are therapeutic equivalents of IPR Pharmaceuticals, Inc.’s Crestor ® tablets. As per IMS MAT May 2016, these tablets hav e annual sales of approximately US$ 6.8 billion in the US. These tablets are indicated for the treatme nt of adult patients with Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinem ia) and adult patients with Homozygous Familial Hypercholesterolemia. ® - All brand names and trademarks are the property of respective owners. 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 47 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 2016 are approx imately US$ 4.3 billion, of which US contributes US$ 2.1 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 8% 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 Direct +91 22 4324 2778 Tel Direct +91 22 4324 2777 Mobile +91 -98203 30182 Mobile +91 99206 65176 E mail [email protected] E mail frederick. [email protected]

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