Baddi-based Morepen Laboratories Limited has received United States Food and Drug Administration (US FDA) approvals for both its bulk drugs manufacturing facilities situated at Baddi and Masulkahna-Parwanoo in Himachal Pradesh.

The Baddi-based units have got US FDA approval for the manufacture of bulk drug “Atorvastatin Calcium”, a cholesterol reducing drug, while Masulkhana-Parwanoo 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- Atorvastatin Calcium and Montelukast Sodium is around 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.

Morepen Laboratories Ltd Chairman and Managing Director Sushil Suri said that 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 2011. Montelukast is the third API approved out of this plant.

He 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.”