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Twin USFDA approvals for Morepen Labs’ Bulk Drugs (API) facilities


Baddi facility gets US FDA nod for bulk drug ‘Atorvastatin’ and Masulkhana facility for ‘Montelukast’

Morepen Laboratories 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 INR 5,000 crore and INR 2,000 crore respectively. The two APIs collectively contributes around INR 150 crore annual revenue to the company’s top line 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.

Speaking on the development, Sushil Suri, Chairman and Managing Director, Morepen Laboratories 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 INR  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.”

Following inspections, both the facilities of Masulkhana and Baddi have been approved without any deficiency and US FDA has not given any adverse remark/ observation (i.e. no Form 483 has been issued), besides a complete approval of the two plants’ quality parameters has been accorded

Suri further pointed out that, “With the help of our experienced and dedicated team, we are fully committed to service the regulated markets and fulfill the compliance requirements for US, European and other global customers. 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.”

Atorvastatin and Montelukast have shown great growth potential during last five years, with a CAGR of 25 per cent and 17 per cent respectively. The company expects decent incremental revenues with more US business coming to company’s kitty in the coming years. The company has a very strong regulatory department and has filed 45 Drug Master Files for all APIs with international documentation and validation data. It has been granted six Certificate of Suitability (COS) applicable in 28 European countries.

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