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List of Drug Master Files (DMF) of Prestwick3_000544 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Prestwick3_000544
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_000544

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 14 USDMF, 7 CEP/COS, 1 JDMF, 12 KDMF, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

26 API Suppliers
14 USDMF
7 CEP/COS
1 JDMF
12 KDMF
9 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 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

166 FDF Dossiers, 36 FDA Orange Book, 65 Europe, 7 Canada, 16 Australia, 13 South Africa, 29 Listed Dossiers

166 FDF Dossiers
36 FDA Orange Book
65 Europe
7 Canada
16 Australia
13 South Africa
29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INHALATION - 28MG, SOLUTION/DROPS;OPHTHALMIC - 0.3%, OINTMENT;OPHTHALMIC - 0.3%, SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%, OINTMENT;OPHTHALMIC - 0.1%;0.3%, SOLUTION;INHALATION - 300MG/5ML, SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%

POWDER;INHALATION - 28MG
SOLUTION/DROPS;OPHTHALMIC - 0.3%
OINTMENT;OPHTHALMIC - 0.3%
SUSPENSION/DROPS;OPHTHALMIC - 0.1%;0.3%
OINTMENT;OPHTHALMIC - 0.1%;0.3%
SOLUTION;INHALATION - 300MG/5ML
SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 7 DKSH, 1 Nippon Fine Chemical, 1 Pharm-RX Chemical, 1 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 6 Actylis, 1 BASF, 1 Curia, 3 Finar, 1 Microlex e.U, 1 Valens Pharmachem

1 Rochem International Inc
7 DKSH
1 Nippon Fine Chemical
1 Pharm-RX Chemical
1 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
6 Actylis
1 BASF
1 Curia
3 Finar
1 Microlex e.U
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

10 Topical, 9 Thickeners and Stabilizers, 8 Parenteral, 6 Solubilizers, 5 Rheology Modifiers, 2 Film Formers & Plasticizers, 2 Emulsifying Agents, 1 Fillers, Diluents & Binders, 1 Surfactant & Foaming Agents, 1 API Stability Enhancers, 1 Dry Powder Inhalation

10 Topical
9 Thickeners and Stabilizers
8 Parenteral
6 Solubilizers
5 Rheology Modifiers
2 Film Formers & Plasticizers
2 Emulsifying Agents
1 Fillers, Diluents & Binders
1 Surfactant & Foaming Agents
1 API Stability Enhancers
1 Dry Powder Inhalation

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 50 Finished Drug Prices, 2 Annual Reports

5 US Medicaid Prescriptions
50 Finished Drug Prices
2 Annual Reports

MARKET PLACE

29 APIs, 6 FDF Dossiers

29 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 3 Health Canada Patents

10 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 2 Others

4 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 2,276 Xls

Filters

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14 All

01 2Actavis Inc

02 2Chongqing DaXin Pharmaceutical

03 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.

04 1Livzon New North River Pharmaceutical

05 1Teva API

06 2Xellia Pharmaceuticals ApS

07 1Zhejiang Hisun Pharmaceutical

08 4Blank

filter Subject Reset all filters

14 All

01 6TOBRAMYCIN

02 1TOBRAMYCIN (NON-STERILE, BULK FORM)

03 1TOBRAMYCIN BASE

04 1TOBRAMYCIN BASE USP (NON-STERILE BULK)

05 1TOBRAMYCIN FORM-1 USP

06 1TOBRAMYCIN SULPHATE USP (NON-STERILE BULK)

07 1TOBRAMYCIN SULPHATE, NON-STERILE BULK

08 1TOBRAMYCIN SULPHATE, USP STERILE BULK

09 1TOBRAMYCIN USP

filter Country Reset all filters

14 All

01 5China

02 2Denmark

03 2Ireland

04 1Israel

05 4Blank

filter Status Reset all filters

14 All

01 6Active

02 8Inactive

filter GDUFA DMF Review Reset all filters

14 All

01 6Complete

02 8Blank

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

List of Suppliers

Product Main Page

01

Chongqing Daxin Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

01

Chongqing Daxin Pharmaceutical Co Lt...

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Digital Content

Tobramycin Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-02

Pay. Date : 2013-03-26

DMF Number : 13774

Submission : 1998-09-01

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Livzon Group Fuzhou Fuxing Pharmaceu...

USDMF

Formnext Forum

Not Confirmed

02

Livzon Group Fuzhou Fuxing Pharmaceu...

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-24

Pay. Date : 2020-09-29

DMF Number : 35042

Submission : 2020-08-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Livzon New North River Pharmaceutica...

USDMF

Formnext Forum

Not Confirmed

03

Livzon New North River Pharmaceutica...

Formnext Forum

Not Confirmed

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Digital Content

Tobramycin (non-sterile, Bulk Form)

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-20

Pay. Date : 2013-06-14

DMF Number : 20724

Submission : 2007-07-26

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

04

Teva Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2012-12-26

Pay. Date : 2012-11-13

DMF Number : 13713

Submission : 1998-09-01

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

05

Xellia Pharmaceuticals Aps

USDMF

Formnext Forum

Not Confirmed

05

Xellia Pharmaceuticals Aps

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Digital Content

Tobramycin Sulphate, Usp Sterile Bulk

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-12

Pay. Date : 2012-11-15

DMF Number : 15629

Submission : 2001-09-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

06

Xellia Pharmaceuticals Aps

USDMF

Formnext Forum

Not Confirmed

06

Xellia Pharmaceuticals Aps

Formnext Forum

Not Confirmed

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Digital Content

Tobramycin Sulphate, Non-sterile Bulk

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-06

Pay. Date : 2012-10-31

DMF Number : 15021

Submission : 2000-09-12

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Pharmachim Economic Corp

Country

USDMF

Formnext Forum

Not Confirmed

07

Pharmachim Economic Corp

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13740

Submission : 1998-09-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

08

Pharmachim Economic Corp

Country

USDMF

Formnext Forum

Not Confirmed

08

Pharmachim Economic Corp

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13739

Submission : 1998-09-01

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

09

Guangdong Qingyuan New North River P...

Country

USDMF

Formnext Forum

Not Confirmed

09

Guangdong Qingyuan New North River P...

Country

Formnext Forum

Not Confirmed

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Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12128

Submission : 1996-09-12

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Pharmachim Economic Corp

Country

USDMF

Formnext Forum

Not Confirmed

10

Pharmachim Economic Corp

Country

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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Country

Virtual Booth

Digital Content

Tobramycin Base

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7578

Submission : 1988-07-07

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

1
2

Prestwick3_000544 Manufacturers | Traders | Suppliers

Prestwick3_000544 Manufacturers, Traders, Suppliers 1

90

We have 7 companies offering Prestwick3_000544

Get in contact with the supplier of your choice:

Actavis Inc
Chongqing DaXin Pharmaceutical
Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
Livzon New North River Pharmaceutical
Teva API
Xellia Pharmaceuticals ApS
Zhejiang Hisun Pharmaceutical

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