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Twin USFDA approvals for Morepen Labs’ bulk drugs (API) facilities

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Morepen Laboratories Ltd has received US FDA (United States Food and Drug Administration) 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 got the nod for manufacturing an anti-asthma bulk drug “Montelukast Sodium” for export to the US market.

It is significant to note here that 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 top line and constitutes 44 per cent of the company’s total API business.

Responding to the development, Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd, said, “History has repeated itself with the company once again securing twin USFDA approvals, without any adverse remarks from the US regulator. 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. The two APIs will also strengthen company’s existing APIs portfolio comprising Loratadine and Desloratadine in the US market.”

“With the help of our experienced and dedicated team, we are fully committed to service the regulated markets and fulfil the compliance requirements for US, European and other global customers. We are continuously working on scaling up our R&D efforts to become a niche player in the global API markets. R&D team of the company is working relentlessly for churning out new technologies and innovative processes towards cost reduction and also towards process simplification,” Suri further stated.

Atorvastatin and Montelukast have shown great growth potential during last 5 years, with a CAGR of 25% and 17% respectively. The company expects decent incremental revenues with more US business coming to company’s kitty in the coming years.

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