Panaji: 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 recently 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 topline and constitutes 44 per cent of the company’s total API business.
The main API facility situated at Baddi (Himachal Pradesh) houses multiple plants for manufacture of different drugs, including Atorvastatin, and is spread across an area of around 50 acres. The Masulkhana facility of Morepen Labs got its first USFDA approval for the manufacture of ‘Loratadine’ in the year 1999, followed by another USFDA approval for ‘Desloratadine’ in the year 2011. Montelukast” is the third API approved out of this plant.
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.”