Glenmark was among a wave of drugmakers that decided having U.S. manufacturing was a good hedge when FDA crackdowns on facilities in India were keeping some of them from exporting to the U.S. The Mumbai-based Glenmark will see if that bet pays off when a $100 million plants open in North Carolina on Tuesday.
The 100,000-square-foot facility is designed to produce not only a variety of fixed dose formulations in tablets and capsules but also vials and prefilled syringes as well as ampoules for inhaled formulations, the drugmaker said. The company expects to build employment there well beyond the 168 workers currently on site.
Glenmark won its first Abbreviated New Drug Application for the Monroe, North Carolina, plant in June with the FDA approval of atovaquone and proguanil hydrochloride tablets, a generic version of GlaxoSmithKline's malaria treatment Malarone. At the time, the company said the approval was the foundation for its portfolio expansion at the new site in.
Glenmark, Cipla, Lupin Pharmaceuticals and other Indian companies have established a beachhead in U.S. drug manufacturing. When Glenmark first decided to build in the U.S., Managing Director Glenn Saldanha told Dow Jones that while it will cost the company more to manufacture in the U.S. compared to India, his company can manufacture more sophisticated, higher-quality products here. "That is the trade-off," he said.
The generics market in the U.S. has become increasingly difficult since Glenmark first decided to build the plant. An oversupply of cheap generics in the U.S. market has squeezed prices to the point that many drugmakers are looking to exit the market. Novartis for one decided to sell off some of its Sandoz generic business in the U.S., stop making products where margins are no longer worth it and concentrate on biosimilars and complex generics.