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

Client Email

Product

DSSTox_CID_3472
USDMF

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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DSSTox_CID_3472

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CHEMISTRY
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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

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

PRICE INFORMATION

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

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

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TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SOLUTION;INTRAVENOUS -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

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

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

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

1 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

7 Finished Drug Prices, 3 Annual Reports

7 Finished Drug Prices
3 Annual Reports

MARKET PLACE

26 APIs, 7 FDF Dossiers

26 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 JP, 1 Others

2 EDQM
1 USP
2 JP
1 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 345 Xls

Filters

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Filters

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14 All

01 2Biophore India Pharmaceuticals Pvt Ltd

02 1Abbott Laboratories

03 1Amphastar Pharmaceuticals

04 1Apothecon Pharmaceuticals

05 1Emcure Pharmaceuticals

06 2Enaltec Labs Private Limited

07 1G&A Assoicates, LLC

08 1MSN Laboratories

09 1Merck Serono

10 1NISSHIN PHARMA INC

11 1Royal DSM

12 1Sunny Pharmtech

filter Subject Reset all filters

14 All

01 1PHYTOMENADIONE (VITAMIN K1)

02 1PHYTONADIONE

03 1PHYTONADIONE ROUTE-B

04 4PHYTONADIONE USP

05 1PHYTONADIONE USP (PROCESS A)

06 1PHYTONADIONE USP [ROUTE CODE "HN"]

07 1PHYTONADIONE USP, NON STERILE, BULK DRUG

08 1PHYTONADIONE, USP

09 1PHYTONADIONE, USP (VITAMIN K1)

10 1PRODUCT 502006, VITAMIN K PHYTONADIONE

11 1VITAMIN K, HYKIMONE

filter Country Reset all filters

14 All

01 1Germany

02 7India

03 1Japan

04 1Netherlands

05 1Taiwan

06 3U.S.A

filter Status Reset all filters

14 All

01 11Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

14 All

01 8Complete

02 6Blank

Transo Pharm USA Vitamin K1 popup

API Suppliers
USDMF
CEP/COS
JDMF
EU WC
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Biophore India Pharmaceuticals Pvt L...

CPhI India 2024

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

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Digital Content

Phytonadione

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 26447

Submission : 2012-09-26

Status : Active

Type : II

Product Web Link

Digital Content

02

Biophore India Pharmaceuticals Pvt L...

CPhI India 2024

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

Contact Supplier

Contact Supplier

Digital Content

Phytonadione Route-b

GDUFA

DMF Review : Complete

Rev. Date : 2014-07-17

Pay. Date : 2014-05-12

DMF Number : 27805

Submission : 2013-12-28

Status : Active

Type : II

Product Web Link

Digital Content

03

Navinta Llc

USDMF

AAPS 2024

Not Confirmed

03

Navinta Llc

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp (process A)

GDUFA

DMF Review : Complete

Rev. Date : 2017-02-06

Pay. Date : 2016-09-20

DMF Number : 30910

Submission : 2016-09-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Emcure Pharmaceuticals Ltd

USDMF

AAPS 2024

Not Confirmed

04

Emcure Pharmaceuticals Ltd

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-08

Pay. Date : 2016-09-26

DMF Number : 30775

Submission : 2016-09-17

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Enaltec Labs Private Ltd

USDMF

AAPS 2024

Not Confirmed

05

Enaltec Labs Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32947

Submission : 2018-08-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Enaltec Labs Private Ltd

USDMF

AAPS 2024

Not Confirmed

06

Enaltec Labs Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-01-05

Pay. Date : 2016-09-23

DMF Number : 30176

Submission : 2016-09-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

G And A Assoc Inc

USDMF

AAPS 2024

Not Confirmed

07

G And A Assoc Inc

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp, Non Sterile, Bulk Drug

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-20

Pay. Date : 2014-03-18

DMF Number : 26654

Submission : 2012-11-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Msn Laboratories Private Ltd

USDMF

AAPS 2024

Not Confirmed

08

Msn Laboratories Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Phytonadione Usp [route Code "hn"]

GDUFA

DMF Review : Complete

Rev. Date : 2015-11-13

Pay. Date : 2015-09-18

DMF Number : 29669

Submission : 2015-09-30

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Dsm Nutritional Products Ltd

USDMF

AAPS 2024

Not Confirmed

09

Dsm Nutritional Products Ltd

AAPS 2024

Not Confirmed

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Digital Content

Phytomenadione (vitamin K1)

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-09

Pay. Date : 2013-07-15

DMF Number : 24530

Submission : 2011-01-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Sunny Pharmtech Inc

USDMF

AAPS 2024

Not Confirmed

10

Sunny Pharmtech Inc

AAPS 2024

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

Phytonadione, Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-03-13

Pay. Date : 2019-12-31

DMF Number : 34054

Submission : 2019-12-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

DSSTox_CID_3472 Manufacturers | Traders | Suppliers

DSSTox_CID_3472 Manufacturers, Traders, Suppliers 1

91

We have 12 companies offering DSSTox_CID_3472

Get in contact with the supplier of your choice:

Biophore India Pharmaceuticals Pvt Ltd
Abbott Laboratories
Amphastar Pharmaceuticals
Apothecon Pharmaceuticals
Emcure Pharmaceuticals
Enaltec Labs Private Limited
G&A Assoicates, LLC
Merck Serono
MSN Laboratories
NISSHIN PHARMA INC
Royal DSM
Sunny Pharmtech

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