Morepen Laboratories gets USFDA approval for two bulk drug (API) facilities

Baddi Facility for Atorvastatin Calcium and Masulkhana facility for Montelukast Sodium

Morepen Laboratories has received USFDA approvals for both its bulk drugs manufacturing facilities situated in Himachal Pradesh. While the Baddi facility has got US FDA approval for the manufacture of bulk drug "Atorvastatin Calcium", a Cholesterol reducing drug, the Masulkhana facility has recently 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 viz. Atorvastatin Calcium and Montelukast Sodium is approximately Rs.5,000 crore and Rs. 2,000 crore respectively. The two APIs collectively contributes around Rs. 150 crore annual revenue to the company's topline and constitutes 44 per cent of the company's total API business.

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