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

New Delhi : 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 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 USFDAapproval 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.

"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," said chairman and MD, Morepen Laboratories Ltd., Sushil Suri.

Morepen Labs got an initial US FDA clearance for Montelukast Sodium in December 2017, based upon approval of customer's 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 viz. Loratadine, Desloratadine (already approved) and Montelukast (new approval). Similarly, the Baddi plant was also inspected by US FDA for the first time, triggered by a US customer for supply of Atorvastatin to the US markets.

The inspection got concluded this month itself. This plant mainly manufactures Atorvastatin amongst other APIs. Following this inspection, 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.

"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," added Suri.

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.

The Masulkhana plant was also inspected and approved by the Therapeutic Goods Agency (TGA), Australia in 2015; 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.

This apart, Morepen also supplies the 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 DMF or Drug Master File) is under consideration of the Japanese authority.

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.