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List of Drug Master Files (DMF) of Tox21_300010 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Tox21_300010
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Tox21_300010

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 10 USDMF, 9 CEP/COS, 11 JDMF, 1 KDMF, 18 NDC API, 23 Listed Suppliers, $ API Reference Price

41 API Suppliers
10 USDMF
9 CEP/COS
11 JDMF
1 KDMF
18 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

367 FDF Dossiers, 126 FDA Orange Book, 15 Europe, 24 Canada, 129 South Africa, 73 Listed Dossiers

367 FDF Dossiers
126 FDA Orange Book
15 Europe
24 Canada
129 South Africa
73 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 356.4MG;30MG;16MG, TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, CAPSULE;ORAL - 325MG;50MG;40MG;30MG, TABLET;ORAL - 250MG;250MG;65MG, TABLET;ORAL - 100MG;1MG, TABLET;ORAL - 325MG;50MG;40MG, SUPPOSITORY;RECTAL - 100MG;2MG, TABLET;ORAL - 325MG;50MG;40MG

CAPSULE;ORAL - 356.4MG;30MG;16MG
TABLET;ORAL - 325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
CAPSULE;ORAL - 325MG;50MG;40MG;30MG
TABLET;ORAL - 250MG;250MG;65MG
TABLET;ORAL - 100MG;1MG
TABLET;ORAL - 325MG;50MG;40MG
SUPPOSITORY;RECTAL - 100MG;2MG
TABLET;ORAL - 325MG;50MG;40MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 14 Rochem International Inc, 30 SPI Pharma, 2 Seqens, 26 DKSH, 2 Jai Radhe Sales, 2 Nippon Fine Chemical, 3 Pharm-RX Chemical, 9 Boai NKY Pharmaceuticals Ltd, 16 Gangwal Healthcare, 1 ICE Pharma, 17 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 21 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 46 BASF, 1 Bioplus Life Sciences, 4 Clariant, 13 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 15 Gangwal Chemicals, 1 Hayashibara, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 26 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 46 Roquette, 20 Seppic, 3 Shandong Focus Biotechnology Co., Ltd, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem, 3 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

129 Fillers, Diluents & Binders, 66 Coating Systems & Additives, 63 Thickeners and Stabilizers, 57 Topical, 56 Solubilizers, 55 Direct Compression, 47 Disintegrants & Superdisintegrants, 44 Taste Masking, 38 Parenteral, 37 Controlled & Modified Release, 37 Granulation, 31 Film Formers & Plasticizers, 28 Lubricants & Glidants, 24 Chewable & Orodispersible Aids, 24 Co-Processed Excipients, 24 Emulsifying Agents, 18 Surfactant & Foaming Agents, 14 API Stability Enhancers, 12 Rheology Modifiers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

129 Fillers, Diluents & Binders
66 Coating Systems & Additives
63 Thickeners and Stabilizers
57 Topical
56 Solubilizers
55 Direct Compression
47 Disintegrants & Superdisintegrants
44 Taste Masking
38 Parenteral
37 Controlled & Modified Release
37 Granulation
31 Film Formers & Plasticizers
28 Lubricants & Glidants
24 Chewable & Orodispersible Aids
24 Co-Processed Excipients
24 Emulsifying Agents
18 Surfactant & Foaming Agents
14 API Stability Enhancers
12 Rheology Modifiers
9 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

32 NEWS #PharmaBuzz

32 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices

1 US Medicaid Prescriptions
6 Finished Drug Prices

MARKET PLACE

78 APIs, 3 FDF Dossiers

78 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 2 JP, 5 Others

2 EDQM
2 USP
2 JP
5 Others

ANALYTICAL

1 BioAnalytical Methods, 13 Analytical Methods

1 BioAnalytical Methods
13 Analytical Methods

$ API Ref.Price (USD/KG) : 18 Xls

Filters

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Filters

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10 All

01 1Boehringer Ingelheim GmbH

02 1CSPC New Nova Pharmaceutical

03 1CULTOR FOOD SCIENCE INC

04 1EURAND

05 1Jilin Shulan Synthetic Pharmaceutical Co.,Ltd.

06 1ReForm Biologics

07 1Shandong Xinhua Pharmaceutical

08 1Siegfried AG

09 1Sunpure Extracts

10 1Tianjin Zhongan Pharmaceutical Co., Ltd

filter Subject Reset all filters

10 All

01 1CAFFEINE

02 1CAFFEINE (ANHYDROUS)

03 1CAFFEINE (HYDROUS, ANHYDROUS FORMS)

04 1CAFFEINE ANHYDROUS

05 1CAFFEINE ANHYDROUS (NATURAL) 99%

06 1CAFFEINE ANHYDROUS, USP

07 1CAFFEINE AS PROCESSED IN INGELHEIM FACILITIES

08 1CAFFEINE FOR INTRAVENOUS AND SUBCUTANEOUS INJECTION

09 1CAFFEINE MICROCAPS

10 1Caffeine

filter Country Reset all filters

10 All

01 4China

02 1Germany

03 1India

04 1Switzerland

05 3U.S.A

filter Status Reset all filters

10 All

01 6Active

02 4Inactive

filter GDUFA DMF Review Reset all filters

10 All

01 2Complete

02 8Blank

API Suppliers
USDMF
CEP/COS
JDMF
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Boehringer Ingelheim Pharma Kg

USDMF

Formnext Forum

Not Confirmed

01

Boehringer Ingelheim Pharma Kg

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Not Confirmed

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Digital Content

Caffeine As Processed In Ingelheim Facilities

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5753

Submission : 1954-03-27

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Cspc Innovation Pharm Co Ltd

USDMF

Formnext Forum

Not Confirmed

02

Cspc Innovation Pharm Co Ltd

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21002

Submission : 2007-11-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Cultor Food Science Inc

U.S.A

USDMF

Formnext Forum

Not Confirmed

03

Cultor Food Science Inc

U.S.A

Formnext Forum

Not Confirmed

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U.S.A

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6182

Submission : 1986-02-07

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

04

Eurand America Inc

USDMF

Formnext Forum

Not Confirmed

04

Eurand America Inc

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Digital Content

Caffeine Microcaps

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10643

Submission : 1993-12-30

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Jilin Shulan Synthetic Pharmaceutica...

USDMF

Formnext Forum

Not Confirmed

05

Jilin Shulan Synthetic Pharmaceutica...

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Not Confirmed

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Digital Content

Caffeine Anhydrous, Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17732

Submission : 2004-07-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Reform Biologics Llc

USDMF

Formnext Forum

Not Confirmed

06

Reform Biologics Llc

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Digital Content

Caffeine For Intravenous And Subcutaneous Inje...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31331

Submission : 2017-01-24

Status : Active

Type : IV

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Shandong Xinhua Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

07

Shandong Xinhua Pharmaceutical Co Lt...

Formnext Forum

Not Confirmed

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Digital Content

Caffeine Anhydrous

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-25

Pay. Date : 2014-02-28

DMF Number : 13092

Submission : 1998-07-10

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Siegfried Pharmachemikalien Minden G...

USDMF

Formnext Forum

Not Confirmed

08

Siegfried Pharmachemikalien Minden G...

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Digital Content

Caffeine (hydrous, Anhydrous Forms)

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-04

Pay. Date : 2012-12-14

DMF Number : 5032

Submission : 1983-08-05

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Sunpure Extracts Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

09

Sunpure Extracts Pvt Ltd

Formnext Forum

Not Confirmed

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Digital Content

Caffeine Anhydrous (natural) 99%

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36604

Submission : 2021-12-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tianjin Zhongan Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

10

Tianjin Zhongan Pharmaceutical Co Lt...

Formnext Forum

Not Confirmed

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Digital Content

Caffeine (anhydrous)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17486

Submission : 2004-06-22

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Tox21_300010 Manufacturers | Traders | Suppliers

Tox21_300010 Manufacturers, Traders, Suppliers 1

33

We have 10 companies offering Tox21_300010

Get in contact with the supplier of your choice:

Boehringer Ingelheim GmbH
CSPC New Nova Pharmaceutical
CULTOR FOOD SCIENCE INC
EURAND
Jilin Shulan Synthetic Pharmaceutical Co.,Ltd.
ReForm Biologics
Shandong Xinhua Pharmaceutical
Siegfried AG
Sunpure Extracts
Tianjin Zhongan Pharmaceutical Co., Ltd

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