American Botanical Drug Corporation
leading CRO specialized in developing botanical products into prescription botanical drugs through US FDA botanical drug IND regulatory filing
top CMO for GMP manufacturing of botanical drug substances and botanical drug products
Our Focus
developing botanical products for US FDA botanical drug regulatory filings and clinical development
pre-clinical studies on botanical products with complex and unknown ingredients
extensive experience in quantitative analytics of botanical substances and products using chemistry and biological techniques
proven know-how and high success rate in shortening botanical drug development process from pre-clinical stage to proof-of-concept (phase-IIa) leveraging the inherent safety nature of botanical products
provides GMP production services for clinical studies
FDA Botanical Drug Guidance
In 2004, the FDA issued the Botanical Drug Development Guidance for Industry, with a second edition released in 2016. This guidance provides a streamlined pathway for botanical drug products derived from plants by waiving the requirements for identifying active ingredients and describing the mechanism of action.
As long as a botanical product demonstrates safety and efficacy during phase I, phase II, and phase III clinical trials, it can be approved as a prescription drug in the US market. There are over 600 botanical drugs in the FDA Investigational New Drug (IND) process.
Botanical Drug Development Pathway
Modern herbal medicines, presented in the form of pills or capsules and demonstrating safety and efficacy on a large scale, are excellent candidates for US prescription botanical drug development:
Time and Cost Efficiency: choosing herbal medicines with a known safety and efficacy profile reduces the time and cost associated with drug discovery
Increased Success Rates: demonstrated safety significantly boosts success rates from pre-clinical tests through to phase IIa trials. Demonstrated efficacy improves their success rate.
While developing the Chemistry, Manufacturing, and Controls (CMC) content for an FDA botanical IND filing can be tedious, it is a manageable challenge.
ABDC maintains a collection of over 10,000 botanical ingredient reference standards, which are used to identify unknown ingredients in botanical products.
ABDC specializes in developing botanical products for regulatory filing and clinical development with the US FDA.
ABDC offers US FDA GMP manufacturing services for both botanical drug substances and botanical drug products.
