Drug firm Morepen Laboratories today said it has received approval from the US health regulator for two bulk drug facilities in Himachal Pradesh manufacturing Atorvastatin Calcium and Montelukast Sodium, respectively.
While the Baddi facility has got US Food and Drug Administration (USFDA) nod to manufacture cholesterol reducing bulk drug Atorvastatin Calcium, the Masulkhana facility has received approval for manufacturing anti-asthma bulk drug Montelukast Sodium, Morepen Laboratories said in a filing to BSE.
"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," it added.
The two active pharmaceutical ingredients (APIs) collectively constitute 44 per cent of the company's total API business, Morepen Laboratories said.
Commenting on the development, Morepen Laboratories Chairman and MD Sushil Suri said, "With this development in place, the company is set to expand its foothold in the combined Rs 7,000 crore US market for Atorvastatin and Montelukast."
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