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List of Drug Master Files (DMF) of Prestwick3_000419 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000419
USDMF

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Prestwick3_000419

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 5 USDMF, 5 CEP/COS, 2 JDMF, 5 EU WC, 8 NDC API, 17 Listed Suppliers, $ API Reference Price

24 API Suppliers
5 USDMF
5 CEP/COS
2 JDMF
5 EU WC
8 NDC API
17 Listed Suppliers
$ API Reference Price

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

71 FDF Dossiers, 4 FDA Orange Book, 11 Europe, 21 Canada, 11 Australia, 24 Listed Dossiers

71 FDF Dossiers
4 FDA Orange Book
11 Europe
21 Canada
11 Australia
24 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Evonik, 4 Rochem International Inc, 11 SPI Pharma, 2 Seqens, 10 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 15 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 15 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 32 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 46 Controlled & Modified Release, 43 Direct Compression, 39 Solubilizers, 38 Thickeners and Stabilizers, 30 Disintegrants & Superdisintegrants, 27 Granulation, 27 Film Formers & Plasticizers, 25 Taste Masking, 24 Topical, 24 Lubricants & Glidants, 21 Co-Processed Excipients, 19 Parenteral, 15 Emulsifying Agents, 11 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 API Stability Enhancers, 7 Surfactant & Foaming Agents, 6 Rheology Modifiers, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

92 Fillers, Diluents & Binders
77 Coating Systems & Additives
46 Controlled & Modified Release
43 Direct Compression
39 Solubilizers
38 Thickeners and Stabilizers
30 Disintegrants & Superdisintegrants
27 Granulation
27 Film Formers & Plasticizers
25 Taste Masking
24 Topical
24 Lubricants & Glidants
21 Co-Processed Excipients
19 Parenteral
15 Emulsifying Agents
11 Chewable & Orodispersible Aids
9 Empty Capsules
8 API Stability Enhancers
7 Surfactant & Foaming Agents
6 Rheology Modifiers
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 Finished Drug Prices, 4 Annual Reports

6 Finished Drug Prices
4 Annual Reports

MARKET PLACE

12 APIs, 8 FDF Dossiers

12 APIs
8 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 2 JP, 9 Others

3 EDQM
5 USP
2 JP
9 Others

$ API Ref.Price (USD/KG) : 96 Xls

Filters

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FILTER :

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5 All

01 1APEX HEALTHCARE LIMITED

02 1Cambrex Corporation

03 1Dishman Carbogen Amcis

04 1Erregierre SpA

05 1Kreative Organics

filter Subject Reset all filters

5 All

01 2BISACODYL

02 2BISACODYL USP

03 1BISACODYL USP-EP

filter Country Reset all filters

5 All

01 3India

02 1Italy

03 1U.S.A

filter Status Reset all filters

5 All

01 5Active

filter GDUFA DMF Review Reset all filters

5 All

01 5Blank

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

List of Suppliers

Product Main Page

01

Apex Healthcare Ltd

USDMF

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Not Confirmed

01

Apex Healthcare Ltd

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Not Confirmed

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Digital Content

Bisacodyl Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36474

Submission : 2022-01-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Cambrex Profarmaco Milano Srl

USDMF

Formnext Forum

Not Confirmed

02

Cambrex Profarmaco Milano Srl

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2248

Submission : 1974-03-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Dishman Carbogen Amcis Ltd

USDMF

Formnext Forum

Not Confirmed

03

Dishman Carbogen Amcis Ltd

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20476

Submission : 2007-04-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Erregierre Spa

USDMF

Formnext Forum

Not Confirmed

04

Erregierre Spa

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Not Confirmed

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Digital Content

Bisacodyl Usp-ep

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14947

Submission : 2000-06-29

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Kreative Organics Private Ltd

USDMF

Formnext Forum

Not Confirmed

05

Kreative Organics Private Ltd

Formnext Forum

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

Bisacodyl Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16058

Submission : 2002-06-28

Status : Active

Type : II

Product Web Link

Digital Content

Prestwick3_000419 Manufacturers | Traders | Suppliers

Prestwick3_000419 Manufacturers, Traders, Suppliers 1

22

We have 5 companies offering Prestwick3_000419

Get in contact with the supplier of your choice:

APEX HEALTHCARE LIMITED
Cambrex Corporation
Dishman Carbogen Amcis
Erregierre SpA
Kreative Organics

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