Sun Pharma gets FDA nod for rosuvastatin calcium tablets

PTI Updated - January 17, 2018 at 10:26 PM.

An employee speaks on phone as he walks out of research and development centre of Sun Pharmaceutical Industries Ltd in Mumbai April 7, 2014. India's Sun Pharmaceutical Industries Ltd Managing Director Dilip Shanghvi said he expects Ranbaxy Laboratories Ltd to become profitable in the short term. Sun said it will buy Ranbaxy in a $3.2 billion all-share deal, creating the world's fifth-largest generic drug maker from two firms struggling with quality issues in the lucrative United States market. Sun plans to focus on remediation of compliance issues that have resulted in bans at multiple Ranbaxy plants, Shanghvi told analysts on a conference call. REUTERS/Danish Siddiqui (INDIA - Tags: BUSINESS HEALTH)

Drug major Sun Pharma has received final approval from the US health regulator USFDA for rosuvastatin calcium tablets, used in lowering cholesterol.

In a BSE filing, Sun Pharma said: “One of its subsidiaries has received final approval from USFDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor, Rosuvastatin Calcium tablets.

Rosuvastatin calcium tabets are generic version of Crestor tablets of IPR Pharmaceuticals, Inc. Approval has been granted in the strengths of 5 mg, 10 mg, 20 mg and 40 mg.

Crestor is used to lower cholesterol and fats (triglycerides) in the blood and is used to reduce the chances of developing problems such as heart disease and strokes.

Quoting IMS sales data for the 12 months to May 2016, Sun Pharma said Rosuvastatin calcium tablets achieved annual sales of around USD 6.78 billion.

Shares of Sun Pharma were trading 1.38 per cent up, at Rs 793 apiece, in the morning trade on BSE.

Published on July 20, 2016 06:50