Sun Pharma receives US FDA approval for generic Crestor

20 Jul 2016 Evaluate

Sun Pharmaceutical Industries and its subsidiaries or associate companies have received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor, 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 have annual sales of approximately $ 6.8 billion in the US. These tablets are indicated for the treatment of adult patients with Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) and adult patients with Homozygous Familial Hypercholesterolemia.

Sun Pharma is the world's fifth 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.

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