About American Botanical Drug Corporation
Excellent Bio-pharmaceutical Consulting in Media
Here at American Botanical Drug Corporation, we are a contract research organization (CRO) specialized in developing botanical products (herbal and hemp) to prescription botanical drugs through US FDA botanical drug IND regulatory filing and clinical development, and contract manufacturing organization (CMO) for ...
FDA Botanical Drug Guidance
In 2004, the FDA issued Botanical Drug Development Guidance for Industry; In 2016, 2nd edition. If a drug product is derived from a single plant or from a mix of plants, the Guidance waives the requirement of:
Identifying active ingredients; Description of the mechanism of action.
As long as a botanical product ...Botanical Drug Development Pathway
Modern herbal medicines in the form of pills or capsules with demonstrated safety and efficacy on large-scale populations are good candidates for US prescription botanical drug development:
Choosing known safe and effective herbal medicines reduces the time and cost of drug discovery Demonstrated safety ...
What we do
Developing botanical product (herbal medicines and hemp ) for US FDA botanical drug regulatory filing and clinical development
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Pre-clinical analytics of botanical products with complex and unknown ingredients
Rich experience in quantitative analytics of botanical product substances using chemistry and biological ...