The U.S. FDA’s Botanical Drug Industry Guidance provides a clear pathway for herbal manufacturers worldwide to enter the U.S. market. The herbal medicine research and production capabilities are quite advanced in China. By combining the goal of regulatory filing to U.S. FDA with access to China's sophisticated knowledge and industry production capabilities for botanical active pharmaceutical ingredients (APIs), companies world-wide can achieve successful and cost-effective botanical drug development.

To bridge this gap, ABDC has invested in and created the Botanical Drug International Development Center on the campus of a leading pharmaceutical university in Nanjing, China, to combine advanced research with our expertise in U.S. regulatory pathways. ABDC owns this Center to offer services:

• Research & Development: the Center has state-of-the-art research facilities, equipment, and personnel specializing in pharmaceutical and herbal medicine.

• ​Regulatory Expertise: ABDC’s U.S.-based experts design studies specifically for U.S. FDA regulatory filings and oversee all testing and experiments conducted at the Center, ensuring every step meets U.S. standards.

The Center provides high-quality, affordable contract services, effectively acting as a dedicated R&D department for global herbal manufacturers, streamlining the complex process of developing botanical drugs, from initial research to successful regulatory submission in the U.S. market.

The Center offers the botanical drug industry with All-in-One Solution:

• specialize in scaling up Active Pharmaceutical Ingredient (API) production from small batches of herbs to large-scale manufacturing that meets strict U.S. Good Manufacturing Practice (GMP) standards. This ensures consistency and quality for your product as it moves through the product development process.

• design and conduct preclinical studies specifically for FDA botanical drug IND filings​

• ​develop and implement the necessary quality control processes required for U.S. FDA Chemistry, Manufacturing, and Controls (CMC) regulatory documentation.

• deve​lop and submit complete U.S. FDA botanical drug Investigational New Drug (IND) packages. This comprehensive service guides your product through the essential regulatory milestones, bringing it one step closer to clinical trials and, ultimately, the U.S. market.