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FDAregulationonpharmaceuticalcocrystals

FDA regulation on pharmaceutical cocrystals

April 30th, 2013

U.S. Food and Drug Administration (FDA) has issued a guidance for industry regarding Regulatory Classification of Pharmaceutical Co-Crystals. This regulation can have a big impact on the application of cocrystals in the pharmeutical industry (innovators and generic companies) paving the way to the use of cocrystals of APIs for new chemical entities and generic products.

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