A U.S. generics manufacturing site that India’s Lupin picked up in its 2015 buyout of GAVIS Pharmaceuticals has now been significantly expanded as the drugmaker continues to make a push into the U.S. market.
This week, Lupin officially opened the expanded 150,000-square-foot manufacturing facility in Somerset, New Jersey, from which it began shipping product earlier this year. The company invested about $20 million on the project and has added 80 workers at the site, reports NJBIZ. It expects to add 50 more, on top of the roughly 250 who worked there when Lupin bought the company.
“This expansion was a tenfold expansion in capacity at the Somerset site and was part of a plan to meet the demand for affordable medicine in the U.S.,” Lupin CEO Vinita Gupta said at an unveiling of the project this week.
Lupin got its U.S. manufacturing foothold in 2015 when it laid out $880 million to buy the small generics maker that specializes in niche products including dermatology controlled substances.The all-cash deal for GAVIS included a 45,000-square-foot manufacturing and R&D operation and 124,000 square feet of packaging and distribution operations. The company was also working on its 105,000-square-foot expansion at the time.
GAVIS and Lupin combined had more than 100 products in the market and more than 160 that were pending approval. Lupin has said it is shooting to release 15 to 20 new products in the U.S. each year.
Those plans were affected, however, when in 2015 the FDA cited a key plant in Goa with a Form 483 with nine observations. The Goa plant was expected to be the main source for about a dozen new products the company had expected to launch in 2016, Lupin Managing Director Nilesh Gupta said last year. The drugmaker gets more than 40% of its revenues from the U.S.
Gupta said in October that the company would get the FDA final responses by the end of last year and expected the FDA to clear the Form 483 shortly after that.
The FDA also hit a Lupin site in Mandideep last year with four observations, two for an API facility and two for a finished formulation facility.