Morepen Laboratories has received approval from United States Food and Drug Administration (USFDA) for Montelukast Sodium, a bulk drug/ API to sell in the US market.
This gives Morepen an entry into the Rs 20 billion US market for Montelukast. The first commercial orders for the bulk drug are expected in Q2 of FY19E.
Sushil Suri, Chairman and Managing Director, 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 130 billion (approx. USD 2 billion) out of which US market alone is Rs 20 billion. The patent for Montelukast has expired in all the markets worldwide. In U.S., the product patent got expired in 2012 and subsequently process patent expired in 2014.
Montelukast is another blockbuster product for Morepen after Loratadine. Morepen is amongst the largest producers of Montelukast globally with an annual capacity of more than 30 tons. Besides, 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 1 billion annual sales from Montelukast Sodium alone, Morepen is going to get a business of around Rs 5 billion from this API in next 3-4 years.
Shares of the company gained Rs 4.1, or 13.53%, to trade at Rs 34.40. The total volume of shares traded was 3,169,460 at the BSE (10.00 a.m., Thursday).