Mumbai: Pharmaceutical company Lupin Ltd said on 14 June it has received US Food and Drug Administration (USFDA) approval for multiple strengths of Trandolapril tablets used in the treatment of hypertension.
“We are delighted with the timely approval of Trandolapril tablets. This approval broadens our growing portfolio of cardiovascular medications,” Lupin Managing Director Kamal Sharma said.
Lupin received the USFDA approval for multiple strengths of 1mg, 2mg and 4mg.
This abbreviated new drug application (ANDA) — Trandolapril tablets, are the AB-rated generic equivalent of Abbott’s Mavik tablets that are indicated for the treatment of hypertension.
According to IMS sales data, the Trandolapril tablets had annual sales of about $49 million for the 12 months ended in December 2006.
Earlier on 31 May, the company had received USFDA approval for Cefadroxil capsules, an antibiotic used for treatment of infections caused by bacteria.
Shares of the company were trading at Rs683.50, up 1.59% on BSE in early morning trade.