Lupin receives US FDA approval for perindopril erbumine tablets
29 Jan 2010
Mumbai-based pharmaceuticals company Lupin Ltd has announced that the US Food and Drug Administration (US FDA) has granted final approval to its US subsidiary, Lupin Pharmaceuticals, Inc. (LPI) for its perindopril erbumine tablets, in 2mg, 4mg and 8mg dosages.
"Commercial shipments of the product will commence shortly," Lupin saidin a statement.
Lupin's perindopril erbumine tablets are AB-rated to Aceon tablets indicated for the treatment of patients with essential hypertension and can be used with conventional treatment for management of coronary artery disease.
Aceon had annual sales of approximately $24 million for the twelve months ended September 2009, based on IMS Health sales data.
Lupin products are marketed in over 70 countries in the world.
The company said it is among the Top 10 the fastest growing generics manufacturers in the two largest pharmaceutical markets of the world – The US, and Japan
In the US it is now ranked 9th by prescriptions sales, growing at 92 per cent. In Japan it is ranked 7th, with a 23 per cent growth rate.
In India Lupin is among the the fastest growing, Top 5 pharmaceutical firms as per ORG IMS - March 2009, and the fastest growing generics firm in South Africa, where it is ranked 6th with a YoY growth of 30 per cent (IMS)
