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.
Lupin has big plans to build market share in the U.S., but those plans were stymied when the FDA cited a facility in Goa from which it expects to ship new products. The head of the Indian drugmaker is now saying that he thinks the facility is in good shape and that it will get an FDA signoff in the next couple of months.
India’s Lupin is recalling nearly 54,000 vials of an antibiotic made at its plant in Mandideep, India. It turns out that it is one of the facilities to receive citations during a recent inspection by the FDA.