New R&D unit coming up at Lupin to develop products for emerging markets

Domestic drug major Lupin, which recently restructured its new drug research programmes, will set up a research and development (R&D) centre to exclusively develop generic drug products for the emerging markets in Latin America, Africa and Australia.

To employ 50 to 60 people, it is expected to be ready in Aurangabad in three months, said Nilesh Gupta, group president and executive director. Lupin currently has an R&D team of 700-plus scientists.

The new centre would allow Lupin to file product dossiers for marketing approvals in all emerging nations. The centre will also cater to Japan. Lupin’s business in that country currently comes through its subsidiary there, Kyowa Pharmaceuticals.

The attempt will be to get some products from Lupin also registered in Japan to augment its product basket. Kyowa has its own R&D and manufacturing facility in Japan.

The parallel research facility will allow entry into newer markets without diluting the current focus of Lupin’s R&D team to make regulatory filings in the US and European region. Lupin had filed a record 37 product registration filings and 19 bulk drug or raw material registration filings with the US Food and Drug Administration during 2009-10. Fourteen regulatory filings were made with European authorities during the same period.

The product registration will form the basis of Lupin’s expansion plans in these regions. The company is on the lookout for acquisitions in countries like Brazil and Mexico to build marketing muscle to promote its branded generics. “Once the stage is set for new product launches, we will evaluate how to develop a marketing network in these countries,” said Gupta.

Most of Lupin’s factories are operating at over 90 per cent capacity. New facilities – its Special Economic Zone at Indore being a major location for future production centres – are expected to be in tune with growth targets.

“We will not set up idle capacities. Our manufacturing locations will keep adding product lines as and when required. We have decided to introduce one new therapeutic area each year. Addition of dedicated manufacturing facilities will happen as volumes go up in each of these categories. We have been spending Rs 400-500 crore annually during the last three years towards capacity expansion. This investment will continue for some more years,” said Gupta.

He said the company had completely restructured its new drug research programmes. If the earlier research was focused mainly on developing herbal-based drugs and known molecules, the focus now was to develop unique first-in-class drugs (new ones which other companies aren’t trying to develop). The company would look at out-licensing these products to multinational drugmakers, he said.