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news.Genmed Holding, a US and Dutch based company focusing on the delivery of low cost generic pharmaceutical drugs directly to distribution channels throughout the world, has entered into the European generic drug market with the receipt of its first marketing and distribution license for paracetamol.
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Paracetamol, also known as acetaminophen, is an over-the-counter (OTC) drug used to treat mild to moderate pain from headaches, backaches, osteoarthritis and to reduce fever.
Genmed first filed its application dossier for paracetamol 500mg tablets with the Dutch Medicines Evaluation Board (MEB) in July 2008.
The Dutch MEB is a member of the European Medicines Agency which evaluates and monitors the efficiency, risks, and quality of human medicinal products.
The submission was done under mutual recognition for the following EU countries; Netherlands, Belgium, Luxembourg, Germany, France, Ireland, and the UK.
Genmed recently received its official marketing authorization license and has been preparing for its first shipments of paracetamol, expected to take place within the first quarter of 2011.