OPKO Health Inc was originally incorporated in Delaware in October 1991 under the name Cytoclonal Pharmaceutics, Inc. The Company is a multi-national biopharmaceutical and diagnostics company. It is developing various solutions to diagnose, treat and prevent various conditions, including point-of-care tests, laboratory developed tests, molecular diagnostics tests, and proprietary pharmaceuticals and vaccines. It owns established pharmaceutical platforms in Chile, Spain, Mexico and Uruguay. It also has established pharmaceutical operations in Brazil. The Company owns a specialty active pharmaceutical ingredients manufacturer in Israel. The Company currently manages its operations in two reportable segments, pharmaceutical and diagnostics. The pharmaceutical segment consists of two operating segments, its (i) pharmaceutical research and development segment which is focused on the research and development of pharmaceutical products and vaccines, and (ii) the pharmaceutical operations it acquired in Chile, Spain, Mexico, Israel, Spain, Uruguay and Brazil. The diagnostics segment consists of two operating segments, the Companys (i) pathology operations it acquired through the acquisition of OPKO Lab and (ii) point-of-care and molecular diagnostics operations. Its main products Rayaldy and Alpharen are in phase 3 clinical development. Its competitors include diagnostic companies, reference laboratories, molecular diagnostic firms, universities and research institutions. The testing, manufacture, distribution, advertising, and marketing of drug and diagnostic products and medical devices are subject to extensive regulation by federal, state, and local governmental authorities in the U.S., including the FDA, and by similar agencies in other countries.
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