Iceland-based Alvogen has a business model that leans heavily on contract manufacturers to get better prices and faster delivery of the products it manufactures. One of those has had manufacturing issues that have led the company to recall two dozen lots of a hypertension drug.
According to the most recent FDA Enforcement report, Alvogen is recalling 24 lots of branded and generic nifedipine extended-release tablets in different dose sizes that it manufactured for itself and for Bayer HealthCare. Nifedipine, branded Adalat, is a channel blocker and hypertension treatment.
According to the report, the drugmaker began the voluntary, class III recall last month because of a chemical contamination of the product. It reported that there was potential cross-contamination with residual sorafenib powder found in an inlet air duct. Sorafenib is a chemotherapy drug.
Alvogen was started in 2009 by Robert Wessman after cashing out his interest in Actavis, a generics company that morphed into Allergan before Allergan unloaded the generics operations last year to Teva for $40.5 billion. Alvogen has its own line of products, including generics and over-the-counter offerings, and does contract manufacturing, but the company also intends to make biosimilars.
Toward that end, Alvogen last year opened a $250 million, 11,800-square-meter (127,000-square-foot) manufacturing and biopharmaceutical development facility in Iceland and expects to have approved product to the market by 2018.