Companies / Brazil
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Manufacturers Losing Out At US FDA?
August 2006 | Industry NewsSorry, you must be a subscriber to view this article in full. If you are a subscriber please login.
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According to US consultancy Montesino Associates, Brazil's manufacturers of active pharmaceutical ingredients (APIs) are missing out on the US market due to failure to adhere to regulatory standards. Drug Master Files (DMFs), which contain secure data on manufacturing and packaging processes used to make drugs, are identified as a key area in which compliance with US FDA standards is inadequate.