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Home Drug Development FDA Approvals

Sun Pharma announces US FDA approval for generic Coreg CR

Yuvraj_pawp by Yuvraj_pawp
27th October 2017
in FDA Approvals

Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Coreg CR®, (carvedilol phosphate) extended release capsules, 10mg, 20mg, 40mg, 80 mg.

These generic carvedilol phosphate extended release capsules, 10mg, 20mg, 40mg, 80mg are therapeutic equivalents of GSK’s Coreg CR® extended release capsules. As per IMS, Coreg CR® had annual sales of approximately US$208 million in the US for the 12 months ended August 2017.

About Sun Pharmaceutical Industries Ltd. (CIN – L24230GJ1993PLC019050)
Sun Pharma is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma’s global presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 11 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top
10 across 3 global markets.

Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information please visit www.sunpharma.com

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