The new facility coming up at Indore will conform to the US Food and Drug Administration and other leading regulatory standards. Land for the project has been acquired and construction will soon begin.
Further, the company plans to create additional active pharmaceutical ingredient manufacturing plants at Mandideep in Madhya Pradesh and Ankaleshwar in Gujarat.
Lupin, which has one of the largest drug manufacturing capacities in India with 11 manufacturing plants, is currently working on almost 100 per cent capacity utilisation. The expansion is to meet the anticipated growth in business, said Dr Kamal K Sharma, managing director.
The company had spent about Rs 170 crore (Rs 1.7 billion) to expand manufacturing facilities last year, including setting up of a new manufacturing facility at Bari Brahmana in Jammu.
The Rs 2028 crore (Rs 20.28 billion) Lupin has filed about 51 Abbreviated New Drug Applications with the US FDA and so far received 23 product approvals, with 16 products in the market.
It plans to file about 15 ANDAs with the US FDA every year. About a dozen of the ANDAs filed are Para IV certifications, which challenge the patents of innovator companies, and over 15 are super generics, which are difficult to make sustained release products.
Its antibiotics such as lisinorpil, cefprozil, cephalexin, meloxicam and sertaline are among the top selling generic drugs in the US market.
Paediatrics segment, valued at about $ 8.5 billion in the US, will be a major focus area for Lupin in future, said Kamal Sharma.
He said Lupin is also looking at acquisition of companies in geographies like Latin America, Japan and the Middle East.
Europe will be the next major focus area for Lupin. Plans are to launch about seven products during the current year. While the company will adopt a direct to market strategy in the UK, it will enter into strategic tie-ups with leading marketing companies for the other major European markets.
Lupin is the only company so far to get marketing approval in France for Cefpodoxime Proxetil, the generic equivalent of Sanofi Aventis's bacterial infection drug Orelox tablets.
The European patent for the drug will expire within two weeks and the company is ready to launch the product. As per IMS, the sales of Orelox in France are currently close of Euro 75 million (close to Rs 420 crore or Rs 4.2 billion), and the European sales were about Euro 130 million (Rs 750 crore or Rs 7.5 billion).
