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Morepen Lab gets USFDA clearance for its bulk drug Montelukast Sodium

20 Dec 2017 Evaluate

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 2000 crore US market for Montelukast. The first commercial orders for the bulk drug are expected in Q2 of FY 2018-19.

Morepen is a well-known pharma company having well equipped Research & Development Centre and is all set to seize the Generic revolution in pharma industry, by filing multiple DMFs and COS for new APIs.

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