22nd Century Group (XXII) Announces Filing of U.S. DMF (Drug Master File) for CBD API; New Global Sales, Marketing and Distribution Agreement with Transo-Pharm for Cannabinoid APIs
BUFFALO, N.Y., Jan. 23, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), 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.
Said James A. Mish, chief executive officer of 22nd Century, “GVB Biopharma is widely recognized for the quality and consistency of its Cannabinoid extracts and ingredients. We are now leveraging these capabilities with our DMF filing to meet the increasing regulatory demands of the supplements markets, and in parallel it expands our reach to the pharmaceutical and OTC markets, where consistently regulated high quality ingredients are a requirement. Our compliance infrastructure will ensure that our customers consistently receive API that meets the appropriate quality standards.”
Additionally, 22nd Century and GVB Biopharma have entered into an agreement with Cannabinoid API Solutions (CAS) and Transo-Pharm for global sales, marketing and distribution of GVB’s Cannabinoid APIs. With more than 35 years of industry experience as a leading global supplier of pharmaceutical grade APIs, Transo-Pharm is a well-established supplier and distributor of pharmaceutical APIs to a broad portfolio of branded and generic finished drug product manufacturers, including more than 75 current active ongoing development programs. Transo-Pharm is partnered with an extensive range of reputable multinational pharmaceutical companies, all of which will have immediate access to GVB’s cannabinoid APIs.
“The partnership with Transo-Pharm will accelerate opportunities to supply our APIs to the largest and most innovative pharmaceutical and consumer goods manufacturers in the world,” said Mish. “We estimate the Cannabinoid Derived Pharmaceutical market to be worth $1 billion in 2022 and growing, a trend we see accelerating as new entrants continue join the market. This partnership immediately provides us with the channel access and reach to support pharmaceutical programs worldwide as well as securing new opportunities in over-the-counter and consumer packaged gods spaces. Our regulated pharmaceutical grade ingredients supply chain will provide for the highest levels of quality, consistency and compliance across our entire customer base.”
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