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List of Drug Master Files (KDMF) for Prestwick3_000997 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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Product

Prestwick3_000997
KDMF

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Prestwick3_000997

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

69 API Suppliers, 30 USDMF, 31 CEP/COS, 6 JDMF, 7 EU WC, 2 KDMF, 26 NDC API, 44 Listed Suppliers, $ API Reference Price

69 API Suppliers
30 USDMF
31 CEP/COS
6 JDMF
7 EU WC
2 KDMF
26 NDC API
44 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

47 Drugs in Development

47 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

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

429 FDF Dossiers, 70 FDA Orange Book, 212 Europe, 32 Canada, 13 Australia, 51 South Africa, 51 Listed Dossiers

429 FDF Dossiers
70 FDA Orange Book
212 Europe
32 Canada
13 Australia
51 South Africa
51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SPRAY, METERED;NASAL - 0.05MG/SPRAY, POWDER;INHALATION - 0.05MG/INH, POWDER;INHALATION - 0.1MG/INH, POWDER;INHALATION - 0.25MG/INH, POWDER;INHALATION - 0.03MG/INH, POWDER;INHALATION - 0.055MG/INH, POWDER;INHALATION - 0.113MG/INH, POWDER;INHALATION - 0.232MG/INH, POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH, POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH, POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH, LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH, AEROSOL, METERED;INHALATION - 0.044MG/INH, AEROSOL, METERED;INHALATION - 0.11MG/INH, AEROSOL, METERED;INHALATION - 0.22MG/INH

OINTMENT;TOPICAL - 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY
SPRAY, METERED;NASAL - 0.05MG/SPRAY
POWDER;INHALATION - 0.05MG/INH
POWDER;INHALATION - 0.1MG/INH
POWDER;INHALATION - 0.25MG/INH
POWDER;INHALATION - 0.03MG/INH
POWDER;INHALATION - 0.055MG/INH
POWDER;INHALATION - 0.113MG/INH
POWDER;INHALATION - 0.232MG/INH
POWDER;INHALATION - 0.055MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.113MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.232MG/INH;EQ 0.014MG BASE/INH
POWDER;INHALATION - 0.1MG/INH;EQ 0.05MG BASE/INH
POWDER;INHALATION - 0.25MG/INH;EQ 0.05MG BASE/INH
POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH
LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
AEROSOL, METERED;INHALATION - 0.045MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.115MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.23MG/INH;EQ 0.021MG BASE/INH
AEROSOL, METERED;INHALATION - 0.044MG/INH
AEROSOL, METERED;INHALATION - 0.11MG/INH
AEROSOL, METERED;INHALATION - 0.22MG/INH

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 2 SPI Pharma, 1 DKSH, 2 Jai Radhe Sales, 9 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 10 Actylis, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 11 BASF, 5 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 20 Kerry, 1 Kima Chemical, 10 Microlex e.U, 1 Nanjing Bold Chemical, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 10 Roquette, 8 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

1 Rochem International Inc
2 SPI Pharma
1 DKSH
2 Jai Radhe Sales
9 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
10 Actylis
3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
11 BASF
5 DFE Pharma
2 Finar
7 Gangwal Chemicals
1 Ideal Cures Pvt Ltd
1 Ingredion Pharma Solutions
20 Kerry
1 Kima Chemical
10 Microlex e.U
1 Nanjing Bold Chemical
1 Pharmatrans-Sanaq
4 Pluviaendo
2 Prachin Chemical
10 Roquette
8 Seppic
2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
10 Sigachi Industries
1 The Dow Chemical Company
1 Valens Pharmachem
2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

40 Fillers, Diluents & Binders, 23 Direct Compression, 21 Solubilizers, 20 Thickeners and Stabilizers, 18 Topical, 15 Disintegrants & Superdisintegrants, 14 Co-Processed Excipients, 13 Parenteral, 12 Granulation, 10 Emulsifying Agents, 10 Controlled & Modified Release, 7 Film Formers & Plasticizers, 6 Surfactant & Foaming Agents, 6 Rheology Modifiers, 6 Coating Systems & Additives, 3 Taste Masking, 2 Chewable & Orodispersible Aids, 2 Lubricants & Glidants, 1 API Stability Enhancers

40 Fillers, Diluents & Binders
23 Direct Compression
21 Solubilizers
20 Thickeners and Stabilizers
18 Topical
15 Disintegrants & Superdisintegrants
14 Co-Processed Excipients
13 Parenteral
12 Granulation
10 Emulsifying Agents
10 Controlled & Modified Release
7 Film Formers & Plasticizers
6 Surfactant & Foaming Agents
6 Rheology Modifiers
6 Coating Systems & Additives
3 Taste Masking
2 Chewable & Orodispersible Aids
2 Lubricants & Glidants
1 API Stability Enhancers

DIGITAL CONTENT

10 DATA COMPILATION #PharmaFlow, 142 NEWS #PharmaBuzz

10 DATA COMPILATION #PharmaFlow
142 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 164 Finished Drug Prices, 12 Annual Reports

4 US Medicaid Prescriptions
164 Finished Drug Prices
12 Annual Reports

MARKET PLACE

15 APIs, 4 FDF Dossiers, 1 EXCIPIENTS

15 APIs
4 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

572 US Patents, 11 US Exclusivities, 53 Health Canada Patents

572 US Patents
11 US Exclusivities
53 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 7 USP, 9 Others

4 EDQM
7 USP
9 Others

$ API Ref.Price (USD/KG) : 19,263 Xls

Filters

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Filters

FILTER :

filter Manufacturer Reset all filters

2 All

01 1Euroapi France

02 1Hovione FarmaCiencia SA

filter Registrant Name Reset all filters

2 All

01 1Korea Mundipharma Co., Ltd.

02 1Synex Co., Ltd.

filter Product Name Reset all filters

2 All

01 2Micronized fluticasone propionate

filter Country Reset all filters

2 All

01 1France

02 1Portugal

EUROAPI Fluticasone

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

List of Suppliers

Product Main Page

01

EUROAPI

Bio-Europe 2024

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Digital Content

Micronized fluticasone propionate

Registrant Name : Korea Mundipharma Co., Ltd.

Registration Date : 2024-05-31

Registration Number : 20240531-209-J-1652

Manufacturer Name : Euroapi France

Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France

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02

Hovione

AAPS 2024

Not Confirmed

Hovione

AAPS 2024

Not Confirmed

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Digital Content

Micronized fluticasone propionate

Registrant Name : Synex Co., Ltd.

Registration Date : 2021-03-25

Registration Number : 20210325-209-J-917

Manufacturer Name : Hovione FarmaCiencia SA

Manufacturer Address : Sete Casas, Loures, 2674-506 Portugal

Product Web Link

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Prestwick3_000997 Manufacturers | Traders | Suppliers

Prestwick3_000997 Manufacturers, Traders, Suppliers 1

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