Mephyton

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 13 USDMF, 3 CEP/COS, 4 JDMF, 4 EU WC, 1 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

96 FDF Dossiers, 34 FDA Orange Book, 14 Europe, 4 Canada, 1 Australia, 25 South Africa, 18 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TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SOLUTION;INTRAVENOUS -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 EUROAPI, 2 Rochem International Inc, 16 SPI Pharma, 7 DKSH, 2 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 Kirsch Pharma, 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, 3 Kerry, 3 Lonza Capsugel, 8 Microlex e.U, 2 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 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 Silverline Chemicals, 1 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Fillers, Diluents & Binders, 28 Parenteral, 21 Solubilizers, 18 Direct Compression, 16 Chewable & Orodispersible Aids, 15 Taste Masking, 13 Topical, 12 Thickeners and Stabilizers, 12 Lubricants & Glidants, 11 Emulsifying Agents, 10 Disintegrants & Superdisintegrants, 8 Co-Processed Excipients, 8 Film Formers & Plasticizers, 8 Empty Capsules, 7 Surfactant & Foaming Agents, 7 Coating Systems & Additives, 7 Granulation, 5 API Stability Enhancers, 2 Coloring Agents, 2 Controlled & Modified Release, 1 Rheology Modifiers

DIGITAL CONTENT

22 News #PharmaBuzz

22 News #PharmaBuzz

GLOBAL SALES INFORMATION

5 Regulatory FDF Prices, 3 Annual Reports

MARKET PLACE

33 APIs, 8 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Exclusivities

1 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 2 JP, 3 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

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USFDA APPLICATION NUMBER - 87954 / DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHYTONADIONE(UNII: A034SE7857) (PHYTONADIONE - UNII:A034SE7857)	PHYTONADIONE	10mg in 1 \| 2mg in 1

Inactive Ingredients

Ingredient Name	Cardinal Health	Hospira, Inc.
BENZYL ALCOHOL(LKG8494WBH)
DEXTROSE MONOHYDRATE(LX22YL083G)
HYDROCHLORIC ACID(QTT17582CB)
POLYOXYL 35 CASTOR OIL(6D4M1DAL6O)
WATER(059QF0KO0R)

Setid 1fc36ced 0e90 486b B459 0414b7b9d0fb Applno 87954 Form Injectable Injection Dosage 1mg 0 5ml - Drug Product Composition: Mephyton

Mephyton

Mephyton

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

27 API Suppliers

13 USDMF

3 CEP/COS

4 JDMF

4 EU WC

1 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

96 FDF Dossiers

34 FDA Orange Book

14 Europe

4 Canada

1 Australia

25 South Africa

18 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 EUROAPI

2 Rochem International Inc

16 SPI Pharma

7 DKSH

2 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 Kirsch Pharma

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

3 Kerry

3 Lonza Capsugel

8 Microlex e.U

2 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

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 Silverline Chemicals

1 Valens Pharmachem

1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Fillers, Diluents & Binders

28 Parenteral

21 Solubilizers

18 Direct Compression

16 Chewable & Orodispersible Aids

15 Taste Masking

13 Topical

12 Thickeners and Stabilizers

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