American Botanical Drug Corporation

a leading contract research organization (CRO) specialized in developing botanical products to prescription botanical drugs through US FDA botanical drug IND regulatory filing, and contract manufacturer organization (CMO) for botanical product GMP manufacturing

Our Focus

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 single plant or from mix of plants, the Guidance waives the requirement of:

     As long as a botanical product demonstrates safety and efficacy during phase I, phase II, and phase III clinical trials, it is approved as a prescription drug on the US market. Two botanical drugs are currently on the US market:

     There are over 600 botanical drugs in the FDA IND process.

Botanical Drug Development Pathway

​​     Modern herbal medicines in forms of pills or capsules with demonstrated safety and efficacy on large scale population are good candidates for US prescription botanical drug development:

The technical challenge of developing CMC contents in FDA IND filing is tedious but doable. The US FDA encourages sponsors to develop hemp products through the botanical drug development pathway to bear medical claims.