News

NANJING, CHINA — In a move poised to streamline the path for herbal medicines to reach the U.S. market, the American Botanical Drug Corporation (ABDC) has opened its new Botanical Drug International Development Center in Nanjing, China. Located on the campus of a leading pharmaceutical university, the ABDC's new facility is designed to combine China’s advanced herbal medicine expertise and the stringent regulatory requirements of the U.S. Food and Drug Administration (FDA).

The new Center, an investment by ABDC, offers a unique "All-in-One Solution" for botanical drug manufacturers worldwide. It is specifically tailored to meet the R&D demands of the U.S. FDA’s Botanical Drug IND development.

"China has long been a global leader in the research and production of herbal medicines," said a spokesperson for ABDC. "By establishing our center in Nanjing, we can harness this profound knowledge base and industrial capability, while our U.S.-based regulatory experts ensure every step meets FDA standards. This combination is a game-changer for herbal companies worldwide aiming to enter the U.S. market."

The center’s services are comprehensive, guiding botanical drug candidates from initial concept to a complete Investigational New Drug (IND) submission. The key offerings include:

• API Scaling and GMP Compliance: The center specializes in developing small reearch batch roduction of Active Pharmaceutical Ingredient (API) production, scaling up to large-scale manufacturing that adheres to U.S. Good Manufacturing Practice (GMP) standards. This addresses a critical challenge in botanical drug development: ensuring consistency and quality across different production runs.

• Targeted Preclinical Studies: ABDC's U.S.-based team designs and oversees preclinical studies specifically for FDA botanical drug IND filings, ensuring all data is relevant and properly documented for regulatory submissions.

• Quality Control and CMC Documentation: The facility develops and implements the necessary quality control processes required for the Chemistry, Manufacturing, and Controls (CMC) section of regulatory documentation, a crucial component of any FDA submission.

• Complete IND Package Submission: The U.S.-based team develop and submit U.S. FDA botanical drug IND packages. This end-to-end service simplifies the complex regulatory process, moving products closer to clinical trials and eventual market approval.

The opening of the Center is a strategic response to the growing global interest in natural products and the increasing clarity provided by the FDA’s guidance. By providing a single point of contact for research, manufacturing, and regulatory services, ABDC aims to make botanical drug development more efficient and cost-effective for companies around the world.

"This is not just about a new facility; it's about creating a clear and reliable pathway for botanical medicines to become approved prescription drugs," the spokesperson added. "We believe this will accelerate innovation in the field and ultimately bring more safe and effective plant-based therapies to patients in the United States."