Morepen gets US FDA clearance for Montelukast Sodium

The first commercial orders for the bulk drug are expected in Q2 of FY 2018-19

The United States Food and Drug Administration (US FDA) has cleared Montelukast Sodium, a bulk drug / API manufactured by Morepen Laboratories, for sale in the US market. This gives Morepen an entry into the Rs 2000 crore (Approx $ 300 million) US market for Montelukast. The first commercial orders for the bulk drug are expected in Q2 of FY 2018-19.

Sushil Suri, CMD, Morepen Laboratories, said, “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.”

Montelukast’s global market is estimated at about Rs 13000 crore (Approx. US$ 2 billion) out of which US market alone is Rs 2,000 crore. The patent for Montelukast has expired in all the markets worldwide. In US, the product patent got expired in 2012 and subsequently process patent expired in 2014.

Morepen is the market leader for Montelukast in India with over 50 per cent market share, supplying to almost all major finished dosage manufacturers in India. Already crossed Rs 100 crore annual sales from Montelukast Sodium alone, Morepen is going to get a business of around Rs. 500 crore from this API in next 3-4 years.

Morepen holds process patent for Montelukast Sodium Amorphous for US, Canada and Europe markets. The company’s manufacturing process yields very less impurities, very less residual solvents, higher assay, better colour of the API and is an environment friendly process as it does not involve use of class II solvents.

Morepen’s API Montelukast supplies are regular to various countries in Europe and also to China. Morepen also holds accreditations for other countries including Canada, Russia, Taiwan, Iran for Montelukast. Commercial sales of Montelukast are presently reaching customers in about 35 countries. The US supplies would also commence following the US FDA clearance.

Montelukast is manufactured at Morepen’s Masulkhana facility in Himachal Pradesh, which has been inspected by various global regulatory agencies like US FDA, EU GMP, TGA and others. Montelukast has obtained COS (Certificate of Suitability) in Europe and IDL (Import Drug Licence) from China.