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Partnership Will Provide Pharmaceutical Grade Cannabinoid Active Ingredients to the Largest Pharmaceutical and Consumer Goods Names in the Industry
22nd Century Group, Inc., a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced filing of a U.S. Drug Master File (DMF) to the US Food & Drug Administration (FDA) for cannabidiol (CBD) API from GVB Biopharma, a 22nd Century Group Company. The submission (DMF 037727) demonstrates 22nd Century Group’s absolute commitment to supplying high quality pharmaceutical grade API to the pharmaceutical industry and OTC markets.
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The validity of GMP certificates for manufacturing sites of API’s located outside the Economic European Area (EEA) are automatically extended until the end of 2023 without the need for further action from the holder of the certificate, unless the issuing/supervisory authority takes any action that affects the validity of the certificate.
This automatic extension is applied in the same manner as for certificates of manufacturing sites located within the EU. Please also refer to the COVID notification on the official EUDRA website.
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