News Feature | July 8, 2014

Lupin To Build 2 New U.S. R&D Centers

By Estel Grace Masangkay


Pharmaceutical firm Lupin announced that it is currently building two new research and development centers in the U.S. dedicated to researching inhalation and complex drug formulations.

According to Lupin’s chairman, this move will help the company continue to assert itself as a leader in generics and specialty pharmaceuticals. Chairman Desh Bandhu Gupta told The Economic Times, “In keeping with our global strategy of building a highly differentiated generic and speciality business, the company is in the process to setting up two dedicated Centers of Excellence for research in inhalation and complex injectables in Florida and Maryland in the US.”

The company revealed that it has invested heavily in R&D in the last few years, increasing its investment of 8.1 percent of its net sales in 2013 to 8.6 percent in the fiscal year 2014.

The company asserted that research continues to be its “backbone,” reporting that, following milestones in its various partnerships, it has increased filings based on its process and formulations research group. In particular, Lupin’s Novel Drug Discovery and Development (NDDD) program, targeting new metabolic/endocrine disorders, pain, autoimmune disease, and cancer treatments, among others, as well as its Biotechnology research program have both seen advancements as of late. Gupta added that Lupin’s Advanced Drug Delivery Systems (ADDS) is aiding the company to build a differentiated pipeline of branded drugs and opportunities for out-licensing. The Biotech group has been redirecting its efforts to develop its biosimilar offerings for advanced markets such as Japan, he said.

The fiscal year 2014 saw 45 regulatory approvals in key markets for Lupin. These include supplemental NDAs in the U.S., EU, Australia, Canada, and Japan. Gupta said, “The company also filed 19 ANDAs (of which, 4 are potentially first-to-file) with the US FDA, 4 MAAs with European regulatory authorities, 4 MAAs in Australia and 2 ANDS in Canada. The cumulative ANDA filings with the USFDA stood at 192 with 99 approvals. The company has 30 confirmed first-to-files including 15 exclusive ones.”

Last month, Lupin announced its commercial launch of Ciprofloxacin for Oral Suspension for the treatment of infections in the U.S. following final approval from the FDA.

As continued growth is a concern for the company,  Lupin has determined future areas for growth and will carefully increase its investments to tap new global opportunities, markets, and technologies