top of page
  • 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:

    • Dividing each herb into 4 to 8 segments.

    • Conducting HPLC (High-Performance Liquid Chromatography) analyses on these segments to identify and isolate specific components.

    • 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%B

    each pick represents an ingredient which was separated, isolated, and stored in a vile, serves as a reference standard

  • 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.
botanical drugs
  • A searchable herb database containing 3,340 herbs with 5 variables:
    • English Name
    • Latin Name
    • Plant Part
    • Traditional Use
    • Traditional Indication
  • A searchable herb formula database containing 46,929 herb formulas with 4 variables:
    • Prescription Name (Pinyin)
    • Composition (Pinyin)
    • Indication in Native Language
    • Reference in Native Language
    The Quantitative Composition variable is omitted from this online version, but available by request for research and development purpose.
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
American Botanical Drug Association

American Botanical Drug Association

ABDA-English
ABDA-Deutsch
ABDA-Français
ABDA-日本語
ABDA-Tiếng Việt
ABDA-हिंदी
ABDA-Português
ABDA-Malaysian
ABDA-bahasa Indonesia
ABDA-ภาษาไทย
ABDA-عربي
ABDA-יִשׂרְאֵלִי
ABDA-español
ABDA-한국인
ABDA-中文
  • 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

    Tai-Ping Fan, PhD FRSA

    SVP, United Kingdom

    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.
Botanical Drug Impact Fund

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.

Subscribe to Get Event Notification

bottom of page