Mumbai: Drug maker Lupin Ltd on Monday said it has received final approval from the US drug regulator for marketing Amlodipine-Benazepril capsules, used for treating high blood pressure, in America.
The company has received a final approval from the US Food and Drug Administration (US FDA) for its Amlodipine-Benazepril capsules, Lupin said in a filing to the Bombay Stock Exchange.
“We are very pleased with the approval of our Amlodipine-Benazepril capsules. This is a significant approval and it broadens our growing portfolio of cardiovascular medications with a strong complement to our existing product line,” Lupin Ltd Group president and executive directors Nilesh Gupta said.
The capsules are available in the strengths of 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules, the filing added.
“The approval reflects the confidence and acceptance of our facility by the FDA, as well as our unwavering commitment to quality and bringing in important products to market,” Gupta added.