Over the past decade, the Botanical Analytic Laboratory has amassed a vast collection of herbs from around the globe, and followed the process below to create a repository bank of botanical ingredients:
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Dividing each herb into 4 to 8 segments.
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Conducting HPLC (High-Performance Liquid Chromatography) analyses on these segments to identify and isolate specific components.
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Storing each isolated ingredient in a vial and precisely regulating the temperature to ensure preservation.
The botanical reference standards repository bank holds over 10,000 botanical ingredient standards with each precisely dosed at 20mg in vials and boasting a purity of HPLC≥98%. Those standards serve as an essential asset for the research and development in botanical and pharmaceutical fields. They are available upon request, ready to support and enhance research and development initiatives worldwide.
Developed & Validated HPLC Method:
Column name: Agilent SB-Aq, 2.1*100mm, 1.8um
Detection wavelength: 203nm, injection volume: 3ul Column temperature: 25℃
Mobile phase gradient: A-water, B-acetonitrile, 0.3ml/min
0-3-6-8-9.5-10.5-15-18-21-25min
20-20-23-24-30-32-34-40-95%Beach pick represents an ingredient which was separated, isolated, and stored in a vile, serves as a reference standard
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Gypenoside XVII
ST04840220
20mg
HPLC≥95%
√
√
√
√
Sanchinoside B1
ST55820305
5mg
HPLC≥90%
√
√
Vinaginsenoside R3
ST81160305
5mg
HPLC≥90%
√
Vinaginsenoside R4
ST55740405
5mg
HPLC≥88%
√
Pseudoginsenoside F11
ST02290120
20mg
HPLC≥98%
√
Pseudoginsenoside Rt3
STG9300205
5mg
HPLC≥95%
√
Pseudoginsenoside Rt5
ST04730120
20mg
HPLC≥98%
√
Ginsenoside F4
STC9260105
5mg
HPLC≥98%
√
20(S)-Ginsenoside Rh1
ST04650120
20mg
HPLC≥98%
√
√
√
√
20(R)-Ginsenoside Rh1
ST05660120
20mg
HPLC≥98%
√
√
√
20(S)-Ginsenoside Rh2
ST00980120
20mg
HPLC≥98%
√
√
√
20(R)-Ginsenoside Rh2
ST05670320
20mg
HPLC≥90%
√
√
√
Ingredient Name
Product#
Quantity in Package
Purity
in fruits
in leaves
in stems
in roots
What are Botanical Drugs?
Botanical drugs are therapeutic materials derived from plants, plant extracts, algae, fungi, or other natural sources. These materials may come from a single plant or a combination of multiple plants. As per the regulations of the US FDA, the collective combination of these components is recognized as the active pharmaceutical ingredient (API) for a botanical drug.
A searchable herb formula database containing 46,929 herb formulas with 4 variables:
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Prescription Name (Pinyin)
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Composition (Pinyin)
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Indication in Native Language
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Reference in Native Language
The Quantitative Composition variable is omitted from this online version, but available by request for research and development purpose.
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In the United States, to transform a product into a prescription medicine, it must undergo the US FDA Investigational New Drug (IND) Application process. This process is a crucial regulatory step. For herbal medicines to become prescription botanical drugs, manufacturers must submit a botanical drug IND application to the US FDA. This botanical drug IND pathway shares similarities with the traditional IND processes for small molecules, large molecules, cell therapies, and gene therapies, yet it also has distinct aspects.
Botanical drug INDs are governed by the FDA's Botanical Drug Development Guidance for Industry. This guidance offers some simplifications over traditional requirements, such as not needing an in-depth description of the molecular structure, mechanism of action, and active ingredients for plant-derived products. However, botanical products are still required to meet the stringent clinical trial standards for safety and efficacy to be approved as prescription medications.
Developing Herbal Medicines to Prescription Botanical Drugs
The American Botanical Drug Association (ABDA), a nonprofit organization with tax-exempt status under section 501(c)(3), dedicates itself to promoting research in herbal medicine and facilitating its progression into FDA-approved prescription botanical drugs.
Contemporary herbal treatments, frequently available in pill or capsule form, have proven their safety and effectiveness through extensive public use.
By leveraging the regulatory framework for botanical drugs in the US and tapping into the vast traditional botanical resources worldwide, ABDA works with entities around the globe to identify herbal medicines with verified safety and efficacy and transform them into prescription botanical drugs.
about the
David Allen, PhD
President & CEO
Mukash Kumar, PhD , RAC, DABRM
SVP, Regulatory & Clinical Services
Stevie Council
SVP, Strategic Initiatives
Lindsey Carnett
SVP, Public Relationship
Perdeep Gupta, PhD
SVP, Research & Development
John Tobin
SVP, Global Business Development
Yong Huang, PhD
Partner, Botanical Drug Impact Fund
Francis Hadji-Minaglou, PhD
SVP, France
Alex Semprini, PhD
SVP, New Zealand
André Boulet, PhD
SVP, Canada
Joerg Gruenwald, PhD
SVP, German
Goran Olsson, PhD
Chief Financial Officer
Huifang Dai, PhD
SVP, China
Chun-Su Yuan, PhD MD
SVP, Scientific Affairs
Don Brown
SVP, Manufacturing & Quality
Jurong Yu
Partner, Botanical Product International Fund
Botanical Drugs Impact Fund
The Botanical Drug Impact Fund (BDIF) operates as an industry fund, serving as a collaborative platform for advancing research and development in the realm of botanical medicines. Within this platform, both institutions and individuals play active roles in the advancement of disease treatment by making contributions to the fund. Contributors can choose specific products or areas of disease treatment that align with their interests.
Numerous safe and efficacious herbal formulations within their respective global markets are typically available in pill or capsule form, holding substantial potential for botanical drug development in the US. However, the complex and time-consuming nature of the drug development process often demands a breadth of expertise that smaller entities may lack.
The Fund serves as a collective platform aimed at fostering collaboration in advancing the research and development of herbal medicines into prescription botanical drugs. This endeavor seeks to address the treatment of challenging medical conditions for which effective chemical drugs are currently lacking. Through the Fund, investors have the opportunity to participate in substantial drug development initiatives, contributing to the advancement of medical science.
