12. Apotex

2014 Generics Sales: $1.7 billion -2%
Worldwide Market Share: 2.3%

Canada ships more generic and OTC drugs to the U.S. than any other country, and the largest generic drugmaker in Canada is Apotex.

Privately owned Apotex, founded in 1974 by now-billionaire Bernard Sherman, has about 6,000 employees in the country and 10,000 worldwide, and says that it produces 260 generic pharmaceuticals in approximately 4,000 dosages.

The company has had lots of issues with the FDA, which several years ago banned two of its Canadian plants from shipping to the U.S. and more recently two of its plants in India. Regulators in Canada followed the FDA and banned drugs from those facilities but more recently said the drugmaker had made enough progress that they would again be allowed in under certain conditions. It has not gotten the same reprieve from the FDA, which may account for the fact that last year Apotex was one of only four generics makers to report declining sales, down 2% from the previous year.

Like some of its competitors, Apotex has moved into biosimilars. In 2013, Apotex began selling a biosimilar version of Amgen's ($AMGN) Neulasta in Europe, a blockbuster drug used by cancer patients in chemotherapy as a way to boost white blood cell count. Earlier this year, the FDA accepted Apotex's application of its filing of Grastofil in the United States. If approved, it would follow Novartis ($NVS), whose Sandoz unit began shipping its biosimilar of Neulasta in the U.S. in September.

-- Eric Palmer (email | Twitter)

For more:
Canada allows Apotex Indian plants to regain access to its markets
Apotex targets Amgen's blockbuster with latest biosimilar app
FDA warning letter scorches a second Apotex plant in India
FDA raises issues with another Apotex plant

12. Apotex
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