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DSSTox_CID_3472

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 14 USDMF, 3 CEP/COS, 5 JDMF, 3 EU WC, 2 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

FINISHED DOSAGE FORMULATIONS

85 FDF Dossiers, 29 FDA Orange Book, 10 Europe, 4 Canada, 1 Australia, 25 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL, INJECTABLE;INJECTION - 1MG/0.5ML, INJECTABLE;INJECTION - 1MG/0.5ML, INJECTABLE;INJECTION - 10MG/ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 15 SPI Pharma, 7 DKSH, 1 Jai Radhe Sales, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 1 Corel Pharma Chem, 2 Finar, 8 Gangwal Chemicals, 3 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 8 Microlex e.U, 2 Nanjing Bold Chemical, 5 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 15 Roquette, 9 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders, 22 Direct Compression, 22 Parenteral, 20 Solubilizers, 14 Taste Masking, 13 Chewable & Orodispersible Aids, 13 Thickeners and Stabilizers, 12 Topical, 12 Lubricants & Glidants, 11 Emulsifying Agents, 11 Co-Processed Excipients, 9 Coating Systems & Additives, 8 Film Formers & Plasticizers, 8 Empty Capsules, 7 Granulation, 7 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Controlled & Modified Release, 2 Coloring Agents, 1 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 Finished Drug Prices, 3 Annual Reports

MARKET PLACE

26 APIs, 7 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 JP, 1 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Biophore India Pharmaceuticals Pvt Ltd	India	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	26447	PHYTONADIONE	2012-09-26	Active	II	N/A
26/09/2024	Biophore India Pharmaceuticals Pvt Ltd	India	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	27805	PHYTONADIONE ROUTE-B	2013-12-28	Active	II	Complete	2014-07-17	2014-05-12

List of Drug Master Files (DMF) of DSSTox_CID_3472 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

DSSTox_CID_3472

DSSTox_CID_3472

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers

14 USDMF

3 CEP/COS

5 JDMF

3 EU WC

2 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

85 FDF Dossiers

29 FDA Orange Book

10 Europe

4 Canada

1 Australia

25 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

INJECTABLE;INJECTION - 1MG/0.5ML

INJECTABLE;INJECTION - 1MG/0.5ML

INJECTABLE;INJECTION - 10MG/ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

15 SPI Pharma

7 DKSH

1 Jai Radhe Sales

6 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

6 Actylis

1 Aeon Procare

3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

8 BASF

1 Corel Pharma Chem

2 Finar

8 Gangwal Chemicals

3 Ingredion Pharma Solutions

6 Kerry

3 Lonza Capsugel

8 Microlex e.U

2 Nanjing Bold Chemical

5 Pluviaendo

1 Prachin Chemical

1 Qualicaps

15 Roquette

9 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

3 Sigachi Industries

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Fillers, Diluents & Binders

22 Direct Compression

22 Parenteral

20 Solubilizers

14 Taste Masking

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons