Actavis PLC, formerly known as Actavis Limited was incorporated in Ireland on May 16, 2013. It is an integrated specialty pharmaceutical company engaged in development, manufacturing, marketing, sale and distribution of generic, branded generic, brand name, biosimilar and over-the-counter pharmaceutical products. It also develops and out-license generic pharmaceutical products in Europe through its Medis third-party business. It operates in three segments, Actavis Pharma, Actavis Specialty Brands and Anda Distribution. The Actavis Pharma segment includes off-patent pharmaceutical products that are therapeutically equivalent to proprietary products. The Actavis Specialty Brands segment includes patent-protected products and certain trademarked off-patent products that the Company sells and markets as brand pharmaceutical products. The Anda Distribution segment distributes generic and brand pharmaceutical products manufactured by third parties, as well as by the Company to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices. It competes with generic manufacturers of pharmaceutical products. It is subject to extensive, complex and evolving regulation by the federal government, the FDA, and to a lesser extent, by the U.S. Drug Enforcement Administration Occupational Safety and Health Administration and state government agencies, as well as by various regulatory agencies in foreign countries where its products or product candidates are being manufactured and/or marketed. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations govern or influence the testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution of its products.