Morepen Laboratories has received USFDA clearance for its bulk drug Montelukast Sodium.

The company stated, “This gives Morepen an entry into the Rs.2,000 crore (approximately USD 300 million) US market for Montelukast. The first commercial orders for the bulk drug are expected in Q2FY19.”

Further, the company is expecting to get business of approx Rs.500 crore from this API in the coming 3-4 years and it is among the largest producers of Montelukast globally with an annual capacity of more than 30 tonnes.

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