American Botanical Drug Corporation
Extensive experience in preclinical studies for botanical active pharmaceutical ingredients (APIs), encompassing both small and large molecules or plant mixtures, drug substances, and drug products, utilizing chemical and biological techniques.
Expertise in scaling up manufacturing processes for botanical APIs, drug substances, and drug product in a GMP environment to meet regulatory CMC requirement
Procurement of botanical raw materials
Specialized in U.S. FDA regulatory services and product & clinical development for botanical drugs
FDA Botanical Drug Guidance
The FDA's Botanical Drug Development Guidance, first issued in 2004 and updated in 2016, offers a simplified regulatory pathway for botanical drug products derived from plants. This streamlined approach waives the traditional requirements to identify specific active ingredients and elucidate their mechanisms of action.
Instead, the focus is on demonstrating the safety and efficacy of the entire botanical product through rigorous clinical trials (Phases I, II, and III). Once these trials are successfully completed, the botanical drug can be approved for prescription use in the US market.
Currently, over 700 botanical drugs are undergoing clinical trials under FDA's Investigational New Drug (IND) process.
Botanical Drug IND Pathway
Modern herbal medicines, particularly those formulated as pills or capsules and backed by extensive clinical evidence, are prime candidates for botanical drug development in the US prescription market. By selecting herbal medicines with a well-established safety and efficacy profile in international markets, pharmaceutical companies can significantly reduce the time and costs associated with drug discovery and development. Key Advantages of Botanical Drug Development:
Accelerated Development: Proven safety profiles can expedite the development process by potentially waiving certain preclinical studies or even Phase 1 clinical trials.
Enhanced Success Rates: Long-term usage and demonstrated efficacy in other markets increase the likelihood of successful clinical trials.
While developing the Chemistry, Manufacturing, and Controls (CMC) section of a botanical drug application can be complex, it is nonetheless a manageable task. Key challenges include defining the precise chemical composition of the botanical product, identifying and quantifying active ingredients, and establishing rigorous quality control standards.
Extensive expertise in U.S. FDA regulatory services and clinical development of drug products containing plant-derived active pharmaceutical ingredients (APIs), with a particular focus on Chemistry, Manufacturing, and Controls (CMC) aspects.
Extensive experience in U.S. FDA regulatory services and clinical development of drug products containing plant-derived active pharmaceutical ingredients (APIs).
U.S. FDA GMP manufacturing services for botanical active pharmaceutical ingredients (APIs), botanical drug substances, and botanical drug products.
