Services

in collaboration with

Quality Control Method Development & Validation

Addressing the complex quality control requirements for botanical drugs is a critical hurdle in the industry. We are uniquely experienced in resolving this challenge, ensuring full regulatory compliance.

Industry Partnership

Centered on our FDA botanical drug IND expertise, leveraging extensive knowledge in botanical medicines, we engage in collaborates with organizations such as yours to propel the development of botanical drug products within the FDA's regulatory framework for botanical drug INDs:

Conducting market research to guide the selection of the most promising botanical product candidates and their IND indications
Reviewing existing information and data to formulate an efficient approach to the IND pathway
Developing and validating quality control methods tailored to specific drug products
Transferring quality control methods and guiding the manufacturing of drug productions intended for clinical trials

Pre-Clinical Services

Unlike the preclinical development process for single-molecule drugs, the preparation of drug products comprising a blend of botanicals is notably more complex. Although the particular ingredients and indications may differ among various IND applications, all preclinical studies for botanical drugs adhere to a shared blueprint for achieving success:

Qualification and quantification of key ingredients in a botanical drug product
Establishment of quality control mechanism for a botanical drug product
Identification of unknown ingredients in a botanical drug product
Quantification of known ingredients in a botanical drug product
In-vitro study for a botanical drug product with multiple ingredients
In-vivo study for a botanical drug product with multiple ingredients
Pre-clinical pharmacokinetics study for a botanical drug product with multiple ingredients
Dose-response study for a botanical drug product with multiple ingredients

FDA Botanical Drug IND Package Development

We follow a structured process to support the development of your botanical drugs INDs:

1. Review of Raw Materials: We conduct a thorough assessment of the raw materials involved in your botanical drug product. This step ensures that all components are in compliance with FDA regulations and guidelines.

2. Content Collection: Our experts gather and compile all the necessary content required for the Investigational New Drug (IND) packet. This includes data on ingredients, quality control, safety, efficacy, and other essential information.

3. IND Packet Development: ABDA's team uses the collected data to create a comprehensive IND packet that aligns with FDA requirements. This packet serves as a foundational document for your botanical drug development process.

4. Submission to FDA: We submit the IND packet to the FDA on your behalf. This step ensures that all required documentation is properly presented to the regulatory agency.

5. FDA Meeting Coordination: participate in meetings with the FDA for discussions related to botanical drug development. These meetings provide an opportunity to address any questions or concerns and seek clarification on FDA expectations.

6. Interpretation of FDA Decision: Upon receiving feedback from the FDA, our experts interpret the FDA decision letter, helping you understand the agency's feedback and recommendations. This interpretation is crucial for making informed decisions on the next steps in drug development process.

ABDA's proficiency in guiding the FDA Botanical Drug Development process simplifies the journey of developing botanical drugs, ensuring alignment with FDA guidelines and increasing the probability of securing successful regulatory approval.

Case Study Training

Walking through some of FDA approved botanical drug IND/NDA cases:

Veregen
Fulyzaq
other cases

to better how to prepare and organize your data for your FDA INDs

Botanical Reference Standards

WE have gathered an extensive range of herbs from across the world, undertaking steps below:

Segmented each herb into 4 to 8 parts
Performed HPLC analyses on these segments to detect and isolate individual ingredients
Encased each isolated ingredient in a vial and maintained the vials at exact temperatures for preservation

As a result, we have a comprehensive repository with over 10,000 botanical ingredient standards. Each standard is dosed at 20mg in a vial, at a purity of over 98% as verified by High-Performance Liquid Chromatography (HPLC).

With our expertise in this area, we can also develop standards for your herbs or herbal products, assisting in the development of quality control methods required by the U.S. FDA.

The repository bank holds over 10,000 botanical ingredient standards dosed at 20mg/vial and boasting a purity of HPLC≥98%.

10% random examples of this repository bank are listed below.

Tubeimoside Ⅲ

3',6-Dimethoxy-4',5,7-trihydroxyisoflavone .

1-Octacosanol

Zeylenol

(2R)-2,3-Dihydroxypropyl (9Z,11E)-13-oxo-9,11-octadecadienoate

Maltopentaose

6,4'-Dimethoxy-5,7,3'-trihydroxyisoflavone

Octyl acetate

Garcinol

Spinosic acid

Saikosaponin b4

TPP

L-Isoleucine

γ-sanshool

11,12-Dehydroursolic acid lactone

Senkyunolide F

Glycerin trilinoleate

25S-inokosterone

Guan-fu base G

Rubiarbonol L

Senkyunolide G

1,2-Dilinoleoyl-3-olein

25R-inokosterone

Eleutheroside D

rubiarbonol A

Continentalic acid

1,2-Dioleoyl-3-linolein

7,2'-Dihydroxy-3',4'-dimethoxyisoflavan 7-O-β-D-glucoside

Tenacigenin B

rubiarbonol B

Aristolochic acid Ⅶa

Isoquercitrin

Licoagroside D

(2S)-beta-Alanyl-L-prolyl-2,4-diamino-N-(phenylmethyl)butanamide acetate

Plonrainoside C

Aristolochic acid Ⅲ

Guvacoline hydrochloride

Pratensein 7-O-β-D-glucopyranoside

N,N’-dimethyldauricine iodide

cis-Acteoside

(+)-R-Pulegone

Guvacoline hydrochloride

Gingerglycolipid B

Isoxaben

Salsaside B

D-Sorbitol

Manninotriose

1-O-Acetylbritannilactone

10-O-[(E)-3,4-Dimethoxycinnamoyl]-catalpol

Suspensaside B

Cis-β-asarone

4-Picolinic acid

Anhydrosafflor yellow B

STIGMASTANOL

Cocculoside

Carboxyatractyloside tripotassium salt

4-Amidopyridine

Capsaicin

(E)-6-O-(p-coumaroyl)scandoside methyl ester

2’-O-Acetyl-3-O-α-L-arabinopyranosylhederagenin 28-O-b-D-glucopyranosyl-(1®6)-β-D-glucopyranoside

Deacetyl asperulosidic acid methyl ester

Naphthemol

Vanillic acid

Lorcaserin Hydrochloride

3’-O-Acetyl-3-O-α-L-arabinopyranosylhederagenin 28-O-b-D-glucopyranosyl-(1®6)-β-D-glucopyranoside

10-deacetylasperulosidic acid

Batatasin III

Ligustrazine

sulfapyrazole

4’-O-acetyl-3-O-α-L-arabinopyranosylhederagenin 28-O-b-D-glucopyranosyl-(1®6)-β-D-glucopyranoside

Ingenol

1,6-Dicarboxyhexane

Methyl gallate

Agaroheptose

Asperosaponin V

Loureirin A

Dimethylmalonic acid

Secoxyloganin

Agaronanose

Hederagenin 28-O-β-D-glucopyranosyl-(1®6)-b-D-glucopyranoside

Alnustone

Magnoloside A

Pulsatilla saponin H

Aaptamine

4’-O-Acetyl-3-O-a-L-arabinosyl-23-hydroxyolea-12-en-28-oic acid

Ganodermanontriol

Magnoloside B

Epibetulinic acid

D-heptamannuronic acid heptasodium salt

3’-O-Acetyl-3-O-a-L-arabinosyl-23-hydroxyolea-12-en-28-oic acid

Carnosic acid

Moxidectin

Aloenin

D-octamannuronic acid octasodium salt

2’-O-Acetyl-3-O-a-L-arabinosyl-23-hydroxyolea-12-en-28-oic acid

Carnosol

Glutathione

Isobergapten

D-nonamannuronic acid nonasodium salt

hederagonic acid

Lupeol

Phenyl benzoate

Theaflavin

3,4,8,9,10-Pentahydroxy Urolithin

3b-Hydroxy-24-norurs-4(23),12-dien-28-oic acid

Tracheloside

L-Tyrosine

Theaflavin-3-gallate

3,8,9,10-tetrahydroxy urolithin

23a-Hydroxy-olean-12-en-3-one

Ganoderic acid B

L-Threonine

Theaflavin-3-gallate

3,8,10-trihydroxy urolithin

3β-O-trans-Feruloyl-2α,23α-dihydroxy-urs-12-en-28-oic acid

Ganoderic acid LM2

4'-Hydroxyacetophenone

Theaflavin-3'-gallate

P-hydroxylbenzyl alcohol

2a,23a-Dihydroxy-3b-O-trans-feruloyloxy-olean-12-en-28-oic acid

Ganoderic acid C1

Parishin A

Bruceine D

Vanillin

2a,3b-Dihydroxy-24-norurs-4(23),12-dien-28-oic acid

Ganoderic acid C1

Parishin B

Tectochrysin

Lovastatin

2a,3b-Dihydroxy-23-norolea-4(24),12-dien-28-oic acid

Ganoderic acid C2

Parishin C

Anhydroicaritin-7-O-glucoside

Simvastatin

pomolic acid 3β-acetate

Ganoderic acid D

Acetylacteoside

Acarbose

Pravastatin sodium

spathodic acid

Ganoderic acid D2

L-(+)-Arabinose

Ginsenoside Rk2

（-）-Bornyl Acetate

Sumaresinolic acid

Ganoderic acid DM

D-(-)-Arabinose

Rubiadin

Kaempferol-3-gentiobioside

2H-Naphtho[1,2-b]pyran-5-carboxylic acid, 6-hydroxy-2-(hydroxymethyl)-2-methyl-, methyl ester (ACI)

Ganoderic acid F

L-Lyxose

Ethyl gallate

Kuwanon C

2-carbomethoxyanthraquinone

Ganoderic acid G

D-(+)-Fucose

Sinigrin

Macranthoside B

lucidin-ω-methylether

Ganoderic acid H

Isorhamnetin-3-O-gentiobioside

Phillygenin

Kadsurin

rubiasin A

Ganoderic acid I

Poricoic acid A

Bullatine A

(±)-Isomucronulatol

1,2-benzenedicarboxylic acid bis(2S-methyl heptyl) ester

Deacetyl ganoderic acid F

Poricoic acid B

Pseudolaric Acid A-O-beta-D-glucopyranoside

Deapio platycodin D

stigmasterol-5,22-diene-3b,7a-diol

Ganoderenic acid A

Dehydropachymic acid

Lucidenic acid A

Garcinone C

(-)Mornaphthoate B

Ganoderenic acid B

Maltotetraose

Lucidenic acid B

Oleanolic acid 3-O-β-D-glucosyl-( 1→3)-α-L-ramnosyl(1→2)-α-L-arabinoside

(+)Mornaphthoate B

Ganoderenic acid C

Maltohexaose

Lucidenic acid C

Hederacolchiside A1

(+)Mornaphthoate A

Ganoderenic acid D

Amnolake

Lucidenic acid D

Lup-20(29)-en-28-oic acid, 3-[β-D-glucopyranosyl(1→4)[a-L-rhamnopyranosyl) (1→2)-a -L-arabinopyranosyl]oxy], (3β,4a)-)

(-)Mornaphthoate C

Ganoderenic acid E

Isosinensetin

Lucidenic acid E

umbellatolide A

(+)Mornaphthoate C

Ganolactone B

Decursin

Lucidenic acid LM1

5-Oxo-D-proline methyl ester

(+)Mornaphthoate D

Ganodermanondiol

Ebracteolatain A

Dimethyl phthalate

Butyl α-D-fructofuranoside

(-)Mornaphthoate D

Ganoderal A

Ebracteolatain A

Dibutyl phthalate

Butyl β-D-fructofuranoside

(+)Mornaphthoate E

Ganoderol A

Taraxasterol

3,8-dihydroxy-urolithin

7α,15-Dihydroxydehydroabietic acid

nonin B

Ganoderol B

Ciwujianoside B

3-hydroxy urolithin

Nodosin

3-deoxyartselaenin C

3β,7β,15β-trihydroxy-11-oxo-lanosta-8-en-24→20 lactone

L-Menthol

Cimigenol-3-O-α-L-arabinoside

12-O-Acetylganoderic acid θ

1-dehydroxy-3,4-dihydroaucubigenin

3β,7β,12β-trihydroxy-11,15-dioxo-lanosta-8-en-24→20 lactone

Polyphyllin G

Baohuoside II

Isomogroside IVe

Sodium Cyclamate

Quercetin 3-O-(6’’-galloyl)-β-D-galactopyranoside

10,12-Octadecadienoic acid-9-oxo-methyl ester

Euonymine

Quinine sulfate dihydrate

Gomisin F

Cimaterol

Stigmastane

2''-O-Rhamnosylicariside II

Isomaltotetraose

Tigloylgomisin H

Cimbuterol

6R,7R-epoxy-1-oleanen-3-ol

Baohuoside VII

Angulatin D

Benzoylgomisin H

4-O-Cinnamoylquinic acid

24-methylenepollinastanyl acetate

Rebaudioside G

Ejaponine B

Hypoxanthine

Soyasaponin III

3β-Hydroxy-11α-methoxyolean-12-ene

Tetrahydroalstonine

Celangulin

3,29-O-dibenzoyloxykarounidiol

Trichodesmine N-oxide

(10E,12Z,15Z)-10,12,15-Octadecatrienoic acid-9-hydroxy-methyl ester

3'-Methoxypuerarin

Celangulatin F

L-Serine

Plantanone B

(9Z,12Z,14E)-9,12,14-Octadecatrienoic acid-16-hydroxy-methyl ester

3'-Methoxypuerarin

Celangulin III

L-Aspartic Acid

Strophanthidol

9-Hydroxy-10E,12Z-octadecadienoic acid methyl ester

Chamigrenal

2H-3,9a-Methano-1-benzoxepin, 3-pyridinecarboxylic acid deriv.

α-Linolenic acid

4,4''-(DIAZOAMINO)DIBENZENESULFONIC ACID DISODIUM SALT

13-Hydroxy-9E,11E-octadecadienoic acid methyl ester

Chrysin 7-O-β-gentiobioside

Angulatin K

Palmitoleic acid

7α-Hydroxy Cholesterol

N-Formyldehydroanonaine

5-O-Methylvisammioside, 6''-O-apiosyl-

Celangulin VII

Stearic acid

Charantin (2:1 mixture of 25,26-Dehydro β-Sitosterol β-D-Glucoside and β-Sitosterol β-D-Glucoside)

Lygodinolide

3,7,4'-Trihydroxy-5-methoxy-8-prenylflavanone, (2R,3R)-

1β-Picolinoyloxy-2β,6α-diacetoxy-8β,13-diisobutanoyloxy-9α-furanoyloxy-4α-hydroxy-β-dihydroagarofuran

Butyl p-hydroxybenzoate

Rapanone

Triptohypol E

Kajiichigoside F1

Celangulin II

Atractylon

Chitobiose Dihydrochloride

5α,8α-Epidioxy-23,24(R)-dimethylcholesta-6,9(11),22-trien-3β-ol

Pomolic acid 28-O-beta-D-glucopyranosyl ester

Celangulin XIX

Phenylbutazone

Ligurobustoside N

N-Demethyl-N-formylde-hydronuciferine

N-benzyl-9Z,12Z,15Z-octadecatrienamide

Angulatin A

Kaempferol-3-O-glucorhamnoside

OLVANIL

N-Acetyldehydroanonaine

N-benzyl-9Z,12Z,15Z-octadecatrienamide

Diphenylpicrylhydrazyl

Dehydroalisol B 23-acetate

Albaspidin AP

3β-Hydroxy-24-mthylenecbolert-5-en-7-one

N-benzyl-Linoleamide

Quinizarin

Columbianetin acetate

Isorhamnetin 3-O-β-D-glucose-7-O-β-D-gentiobioside

Oleana-11,l3( 18)-dien-3β-ol

N-benzyl-Hexadecanamide

16-Oxoalisol A

Columbianetin

Didemethyl Curcumin

3β-Hydroxy-4α,14α-dimethyl-5α-ergosta-8,24(28)-dien-7-one

Morusinol

Carveol

Angelol K

cis-13,16-Docosadienoic acid methyl ester

euphorbia factor L8

Kuwanon A

Resveratrol 4′-O-glucopyranoside

Angelol B

Maltooctaose

4H-Dibenzo[de,g]quinoline-6-acetyl-5,6-dihydro-1,2-dimethoxy

Kuwanon H

Polyporusterone A

Angelol A

Apigenin-7-O-glucuronide-6'-ethyl ester

N-Formyl-nornuciferin

Tubeimoside Ⅱ

Beesioside Q

Embelin

Neoanhydropodophyllol

N-Acetyl-nornuciferin

Bayogenin 3-O-β-D-glucopyranoside

Hederacholchiside E

Pseudolaric acid B-O-beta-D-glucopyranoside

(3-Carboxypropyl)Trimethylammonium Chloride

N-Fornzyl-annonain

Sanggenol L

Polyporusterone B

Talatisamine

Cyclosporin D

Ridurtion de la N-fomylxjlopine

Camelliaside A

Polyporusterone B

Atractyloside A

6''-O-Acetylsaikosaponin A

N-acetilnonaina

Camelliaside B

Hamaudol

Atractyloside A

Maltononaose

N-Acetylxylopine

Bernardioside A

Ophiopogonanone H

Hederacoside D

Quercetin 3-O-sophoroside-7-O-rhamnoside

(3β,7β,22E)-Stigmasta-5,22-diene-3,7-diol

Sanggenone H

Ophiopogonanone A

Adenine

D-trimannuronic acid trisodium salt

1β,3β,11α-trihydroxy-urs-12-ene

3,3'-Di-O-methylellagic acid 4'-glucoside

6-aldehydo-isoophiopogonone B

Rosamultin

L-triguluronic acid trisodium salt

Methyl Orsellinate

7-O-Ethylmorroniside

6-aldehydo-isoophiopogonone A

1-Kestose

Thiacloprid-Amid, Pestanal

Methy 2,4-Dihydroxy-3, 6-dimethylbenzoate

Methylnissolin

Aloeresin

1F-fructofuranosylnystose

Chitoheptaose Heptahydrochloride

Ethyl everninate

Jujuboside B1

Proanthocyanidin B5

Baccatin Ⅲ

Arborin; Glycosin; Glycosine

Diethyl pimelate

Isoliquiritin apioside

Methyl methanthranilate

Cabazitaxel

4'-Prenyloxyresveratrol

(6R)-eucomegastigmane A

Isoliquiritin apioside

Tartaric acid

7-Xylose-10-deacetyltaxol

7-Hydroxy-2-(p-hydroxyphenyl)-2,3-dihydro-4H-1-benzopyran-3-one

9-Hydroxymegastigm-5-en-4-one

Chrysoobtusin

Vitexin-4″-O-glucoside

Saikosaponin E

17-Hydroxy Capsaicin

Salicifoliol

Ginsenoside F4

(+)-Alismol

Prosaikogenin D

Thymopentin

5,6-Dimethoxyphthalide

Ginsenoside Rh4

(-)-Maackiain

Yadanziolide A

BIXIN

Methyl (2S,4aS,6R,6aR,10aS,10bS)-2-(3-furanyl)-1,4,4a,5,6,6a,9,10,10a,10b-decahydro-6-hydroxy-6a,10b-dimethyl-4-oxo-2H-naphtho[2,1-c]pyran-7-carboxylate

Lonicerin

2,4,6-Trihydroxychalcone

Hydroprotopine

Genistein 7-O-β-D-glucopyranoside-4’-O-[α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranoside]

tinosporol B

Kaempferol 3-O-sophoroside

4-hydroxyderricin

L-Hydroxyproline

Cholesterol β-D-glucoside

tinosporol C

Rhodiosin

2,3,4′-Trihydroxy-3′,5′-dimethoxypropiophenone

Ginsenoside Rg5

Dihydro Homocapsaicin II

lirioresinol A

Rhodiosin

1,4-β-Xylobiose

Ginsenoside Rg5

NEOLINUSTATIN(P)

2H-Naphtho[2,1-c]pyran-7-carboxylic acid, 2-(3-furanyl)-1,4,4a,5,6,6a,9,10,10a,10b-decahydro-6,9-dihydroxy-6a,10b-dimethyl-4-oxo-, methyl ester, [2S-(2α,4aβ,6α,6aβ,9β,10aβ,10bα)]- (9CI)

（6aR，11aR)-9,10-dimethoxy pterocarpan-3-O-β-D-glucopyanoside

O-β-D-Xylopyranosyl-(1→4)-O-β-D-xylopyranosyl-(1→4)-D-xylose

Euphorbiasteroid

4'-hydroxylosthole；E-Methylarnottinin

Floridolide B

Dichotomitin

Xylotetrose

Vincosamide

4-Hydroxyphenylacetaldehyde, approximately >15% by weight in Ethyl Acetate

Tinosporol A

Neoisoliquiritin

(+)-Norisoboldine

3α-dihydrocadambine

sesaminol

4-Hydroxy-4-( 3-oxo-1-butenyl) -3,5,5-trimethylcyclohex-2-en-1-one

Neoliquiritin

Yibeissine

Polyporenic acid C

3-Dehydroverticine

threo-Guaiacylglycerol-β-O-4’-coniferyl ether

Isobavachin

Brevelin A

Pachymic acid

Apigenin 7-O-diglucuronide

erythro-Guaiacylglycerol-β-O-4’-coniferyl alcohol

6-Pentadecylsalicylic acid

Cinnamyl cinnamate

Purpurin

Florfenicol amine

rel-(1R,2R)-1-(4-Hydroxy-3,5-dimethoxyphenyl)-2-[4-[(1E)-3-hydroxy-1-propen-1-yl]-2-methoxyphenoxy]-1,3-propanediol

Isoforsythiaside

4-Butylresorcinol

Forsythoside I

veratriloside

Borapetoside F

Gitogenin

Quercetin 3-O-β-D-(6-O-galloyl)glucopyranoside

Sucrose

13,15-dideoxyaconitine

Borapetoside E

Polygalacin D

10,11-Dihydro-10-hydroxycarbamazepine

L-Citrulline

Podophyllol

Crispene E

Hosenkoside F

Skimmianine

Sinomenine

Oleuropein Aglycone

5-[6-Methoxy-7-(3-methyl-2-buten-1-yl)-2-benzofuranyl]-1,3-benzenediol

Hosenkoside G

Butin

Salvigenin

D-dimannuronic acid disodium salt

Regiafuran A

Hosenkoside K

Germacrene D

Ilexoside K

L-diguluronic acid disodium salt

Moracin T