Dexone 4

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ACTIVE PHARMA INGREDIENTS

96 API Suppliers, 27 USDMF, 12 CEP/COS, 6 JDMF, 4 EU WC, 7 KDMF, 26 NDC API, 1 VMF, 54 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

690 Drugs in Development

690 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

413 FDF Dossiers, 130 FDA Orange Book, 164 Europe, 25 Canada, 8 Australia, 17 South Africa, 69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OPHTHALMIC - 0.1%, SUSPENSION/DROPS;OTIC - 0.3%;0.1%, OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM, SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%, OINTMENT;OPHTHALMIC - 0.1%;0.3%, SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%, TABLET;ORAL - 0.5MG, TABLET;ORAL - 0.75MG, TABLET;ORAL - 1.5MG, TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, TABLET;ORAL - 4MG, TABLET;ORAL - 6MG, SOLUTION;ORAL - 0.5MG/5ML, ELIXIR;ORAL - 0.5MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 7 SPI Pharma, 10 DKSH, 1 Pharm-RX Chemical, 6 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 9 Kirsch Pharma, 1 ACG Worldwide, 15 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 3 CD Formulation, 10 Corel Pharma Chem, 1 Curia, 6 DFE Pharma, 3 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 23 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 30 Roquette, 15 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders, 41 Coating Systems & Additives, 33 Thickeners and Stabilizers, 28 Parenteral, 28 Direct Compression, 26 Solubilizers, 22 Topical, 21 Granulation, 18 Controlled & Modified Release, 18 Film Formers & Plasticizers, 17 Disintegrants & Superdisintegrants, 17 Taste Masking, 12 Rheology Modifiers, 12 Lubricants & Glidants, 12 Co-Processed Excipients, 9 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 Surfactant & Foaming Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 276 News #PharmaBuzz

GLOBAL SALES INFORMATION

39 US Medicaid Prescriptions, 82 Regulatory FDF Prices, 7 Annual Reports

MARKET PLACE

69 APIs, 61 FDF Dossiers

PATENTS & EXCLUSIVITIES

18 US Patents, 2 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

8 EDQM, 6 USP, 2 JP, 16 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 13422 / DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXAMETHASONE(UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)	DEXAMETHASONE	1mg in 1

Inactive Ingredients

Ingredient Name	Alcon Laboratories, Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
EDETATE DISODIUM(7FLD91C86K)
HYPROMELLOSES(3NXW29V3WO)
POLYSORBATE 80(6OZP39ZG8H)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
WATER(059QF0KO0R)

Setid Ecd69437 Dd1a 453b 991d 5c5f277a3abd Applno 13422 Form Suspension Drops Ophthalmic Dosage 0 1 - Drug Product Composition: Dexone 4

Dexone 4

Dexone 4

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

96 API Suppliers

27 USDMF

12 CEP/COS

6 JDMF

4 EU WC

7 KDMF

26 NDC API

1 VMF

54 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

690 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

413 FDF Dossiers

130 FDA Orange Book

164 Europe

25 Canada

8 Australia

17 South Africa

69 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OPHTHALMIC - 0.1%

SUSPENSION/DROPS;OTIC - 0.3%;0.1%

OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%

OINTMENT;OPHTHALMIC - 0.1%;0.3%

SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%

TABLET;ORAL - 0.5MG

TABLET;ORAL - 0.75MG

TABLET;ORAL - 1.5MG

TABLET;ORAL - 1MG

TABLET;ORAL - 2MG

TABLET;ORAL - 4MG

TABLET;ORAL - 6MG

SOLUTION;ORAL - 0.5MG/5ML

ELIXIR;ORAL - 0.5MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI

3 Rochem International Inc

7 SPI Pharma

10 DKSH

1 Pharm-RX Chemical

6 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

9 Kirsch Pharma

1 ACG Worldwide

15 Actylis

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 BASF

3 CD Formulation

10 Corel Pharma Chem

1 Curia

6 DFE Pharma

3 Finar

8 Gangwal Chemicals

4 Ideal Cures

3 Ingredion Pharma Solutions

23 Kerry

2 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

1 Novo Excipients

1 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd