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Morepen Laboratories Ltd has received USFDA (United States Food and Drug Administration) approval for both its bulk drugs manufacturing facilities situated in Himachal Pradesh. While the Baddi facility has got USFDA approval for the manufacture of bulk drug Atorvastatin Calcium - a cholesterol reducing drug, the Masulkhana facility has recently got the approval for manufacturing an anti-asthma bulk drug Montelukast Sodium for export to the US market.
The US market size for bulk drugs - Atorvastatin Calcium and Montelukast Sodium is approximately Rs 5,000 crore and Rs 2,000 crore, respectively. The two APIs collectively contribute around Rs 150 crore annual revenue to the company’s top line and constitutes 44 per cent of the company’s total API business.
Morepen Labs had got an initial USFDA clearance for Montelukast Sodium in December 2017, based upon the approval for customer’s abbreviated new drug application (ANDA) which triggered an inspection of its Masulkhana facility in 2018.
The facility had gone for regular inspection for all the three products manufactured therein - Loratadine, Desloratadine (already approved) and Montelukast (new approval).
Similarly, the Baddi plant was also inspected by USFDA for the first time, triggered by a US customer, for the supply of Atorvastatin to the US markets. The inspection was concluded in July. This plant mainly manufactures Atorvastatin among other APIs.
Following this inspection, both the facilities of Masulkhana and Baddi have been approved without any deficiency and USFDA has not given any adverse remark or observation (i.e. no Form 483 has been issued). Besides a complete approval of the two plants’ quality parameters has been accorded.
The Masulkhana plant was also inspected and approved by the Therapeutic Goods Agency (TGA), Australia in 2015 and minor improvements were made in keeping with the TGA requirements. In addition, the plant has received an EU-GMP certification following an inspection by the Slovenian drug regulatory authorities in 2013.
The main API facility situated at Baddi in Himachal Pradesh houses multiple plants for the manufacture of different drugs, including Atorvastatin, and is spread across around 50 acres. The Masulkhana facility got its first USFDA approval for the manufacture of ‘Loratadine’ in 1999, followed by another USFDA approval for ‘Desloratadine’ in 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. The two APIs will also strengthen the company’s existing APIs portfolio comprising Loratadine and Desloratadine in the US market.”
Suri further said, “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.”
Atorvastatin and Montelukast have shown great growth potential during the last five years, with a compound annual growth rate of 25 per cent and 17 per cent, respectively. Morepen expects decent incremental revenues with more US business coming to its kitty in the coming years.
Morepen had also started supplying APIs for Canada and the European Union since 1999, and intermediates for Loratadine for the Japanese market. Its application for marketing of API (known as Drug Master File) is under the consideration of the Japanese authority.
The company has filed 45 drug master files for all APIs with international documentation and validation data. It has been granted six certificate of suitability applicable in 28 European countries.
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