Morepen gets USFDA’s approvals for 2 manufacturing facilities in Himachal Pradesh

30 Jul 2018 Evaluate

Morepen Laboratories has received USFDA (United States Food and Drug Administration) approvals for both its bulk drugs manufacturing facilities situated in Himachal Pradesh. The Baddi facility has got USFDA approval for the manufacture of bulk drug Atorvastatin Calcium a Cholesterol reducing drug, while the Masulkhana facility has got the nod for manufacturing an anti-asthma bulk drug Montelukast Sodium for export to the US market.

The US market size for these two bulk drugs namely Atorvastatin Calcium and Montelukast Sodium is around Rs 5000 crore and Rs 2000 crore respectively. The two APIs collectively contributes around Rs 150 crore annual revenue to the company’s topline and constitutes 44% of the company’s total API business.

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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