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List of Drug Master Files (DMF) of Tox21_300124 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Tox21_300124
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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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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

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xyz-pharma-m-2024-09-09

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Tox21_300124

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

12 API Suppliers, 2 USDMF, 1 CEP/COS, 4 JDMF, 2 NDC API, 6 Listed Suppliers, $ API Reference Price

12 API Suppliers
2 USDMF
1 CEP/COS
4 JDMF
2 NDC API
6 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

37 Drugs in Development

37 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Exports

FINISHED DOSAGE FORMULATIONS

82 FDF Dossiers, 9 FDA Orange Book, 15 Europe, 49 Canada, 7 South Africa, 2 Listed Dossiers

82 FDF Dossiers
9 FDA Orange Book
15 Europe
49 Canada
7 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML, FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

SOLUTION;IRRIGATION - 6.602GM/100ML;198MG/100ML;3.177GM/100ML
FOR SOLUTION;ORAL - 12GM/PACKET;3.5GM/PACKET;10MG/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 12GM/BOT;3.5GM/BOT;10MG/BOT

RELATED EXCIPIENT COMPANIES

10 Rochem International Inc, 15 SPI Pharma, 2 Seqens, 10 DKSH, 2 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 22 BASF, 1 Bioplus Life Sciences, 2 Clariant, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

62 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 32 Thickeners and Stabilizers, 31 Controlled & Modified Release, 28 Direct Compression, 25 Taste Masking, 23 Parenteral, 22 Topical, 20 Film Formers & Plasticizers, 17 Solubilizers, 17 Lubricants & Glidants, 17 Granulation, 14 Chewable & Orodispersible Aids, 13 Co-Processed Excipients, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 1 Soft Gelatin

62 Fillers, Diluents & Binders
54 Coating Systems & Additives
32 Thickeners and Stabilizers
31 Controlled & Modified Release
28 Direct Compression
25 Taste Masking
23 Parenteral
22 Topical
20 Film Formers & Plasticizers
17 Solubilizers
17 Lubricants & Glidants
17 Granulation
14 Chewable & Orodispersible Aids
13 Co-Processed Excipients
10 Disintegrants & Superdisintegrants
9 Empty Capsules
7 API Stability Enhancers
6 Emulsifying Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 20 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 14 Finished Drug Prices

1 US Medicaid Prescriptions
14 Finished Drug Prices

MARKET PLACE

28 APIs, 1 FDF Dossiers, 13 EXCIPIENTS, 1 Intermediates

28 APIs
1 FDF Dossiers
13 EXCIPIENTS
1 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 4 USP, 1 Others

1 EDQM
4 USP
1 Others

$ API Ref.Price (USD/KG) : 3 Xls

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2 All

01 1GE Healthcare Inc

02 1Jungbunzlauer International AG

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2 All

01 1ANHYDROUS CITRIC ACID

02 1FASTLAB FDG CITRATE CASSETTE PACK

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2 All

01 1Switzerland

02 1United Kingdom

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2 All

01 2Active

filter GDUFA DMF Review Reset all filters

2 All

01 1Complete

02 1Blank

API Suppliers
USDMF
CEP/COS
JDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Ge Healthcare Inc

USDMF

Formnext Forum

Not Confirmed

01

Ge Healthcare Inc

Formnext Forum

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Fastlab Fdg Citrate Cassette Pack

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 25371

Submission : 2011-10-07

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Jungbunzlauer Ladenburg Gmbh

USDMF

Formnext Forum

Not Confirmed

02

Jungbunzlauer Ladenburg Gmbh

Formnext Forum

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Anhydrous Citric Acid

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-07

Pay. Date : 2013-09-27

DMF Number : 23078

Submission : 2009-08-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Tox21_300124 Manufacturers | Traders | Suppliers

Tox21_300124 Manufacturers, Traders, Suppliers 1

62

We have 2 companies offering Tox21_300124

Get in contact with the supplier of your choice:

GE Healthcare Inc
Jungbunzlauer International AG

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