Comments
New Delhi-based pharmaceuticals major Morepen Laboratories Ltd has received the clearance of the the United States Food and Drug Administration (USFDA) for its bulk drug Montelukast Sodium which helps control the symptoms of asthma.
“This gives Morepen an entry into the ₹2,000 crore US market for Montelukast,” a company release said. The first commercial orders for the bulk drug are expected in the second quarter of the next fiscal, it added.
Montelukast’s global market is estimated at about ₹13,000 crore out of which US market alone is ₹2,000 crore. The patent for Montelukast has expired in all markets worldwide. In the US, the product patent for the drug expired in 2012 and subsequently the process patent expired in 2014.
“It’s a big development for us as it is in recognition of our continuous efforts to produce world class API’s over more than three decades. Our image as a quality API supplier gets cemented with the entry of Montelukast in the US market. It would provide a major boost to the company's top line and thus the bottom line in the years to come,” said Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd.
Montelukast is manufactured at Morepen’s Masulkhana facility, which has been inspected by various global regulatory agencies like USFDA, EU GMP, TGA and others, the release added.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.