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Morepen receives US FDA clearance

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Morepen to sell Montelukast Sodium, a bulk drug/ API in US market

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

Sushil Suri, Chairman and MD, Morepen Laboratories says, “It’s a big development for us as it is in recognition of our continuous effort to produce world class API’s over more than three decades. Our image as a quality API supplier gets cemented with the entry of Montelukastin the US market. It would provide a major boost to the company’s top line and thus bottom line in the years to come.”

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

Montelukast is another blockbuster product for Morepen at 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 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 manufaturing 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 in China. Morepen also holds accrediations for other countries including Canada, Russia, Taiwan, Iran for Montelukast. Commercial sales of Montelukast are presently reaching customers in about 35 countries. US supplies would also commence following the US FDA clearance.

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