Morepen gets US FDA clearance for its bulk drug Montelukast Sodium

Mumbai, Dec 20: Morepen Laboratories Ltd said that The United States Food and Drug Administration (US FDA) has cleared Montelukast Sodium, a bulk drug / API manufactured by company, for sale in the US market.

This gives Morepen an entry into the Rs 2000 crore (approx.USD300mn) US market for Montelukast.
The first commercial orders for the bulk drug are expected in Q2 of FY 2018-19.

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