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List of Drug Master Files (DMF) of Prestwick3_000351 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000351
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_000351

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 23 USDMF, 8 CEP/COS, 6 EU WC, 12 KDMF, 9 NDC API, 16 Listed Suppliers, $ API Reference Price

35 API Suppliers
23 USDMF
8 CEP/COS
6 EU WC
12 KDMF
9 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 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

6 API Suppliers

6 API Suppliers

FINISHED DOSAGE FORMULATIONS

202 FDF Dossiers, 116 FDA Orange Book, 62 Europe, 8 Canada, 2 Australia, 5 South Africa, 9 Listed Dossiers

202 FDF Dossiers
116 FDA Orange Book
62 Europe
8 Canada
2 Australia
5 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG;25MG, TABLET;ORAL - 50MG;25MG, TABLET;ORAL - 15MG, TABLET;ORAL - 25MG, TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG, TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

TABLET;ORAL - 100MG;25MG
TABLET;ORAL - 50MG;25MG
TABLET;ORAL - 15MG
TABLET;ORAL - 25MG
TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG
TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 16 SPI Pharma, 4 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Pfanstiehl, 1 ACG Worldwide, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 17 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 22 Roquette, 8 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 37 Direct Compression, 30 Disintegrants & Superdisintegrants, 25 Controlled & Modified Release, 24 Lubricants & Glidants, 23 Granulation, 17 Thickeners and Stabilizers, 17 Co-Processed Excipients, 17 Taste Masking, 15 Chewable & Orodispersible Aids, 10 Film Formers & Plasticizers, 9 Solubilizers, 6 Parenteral, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 2 Topical, 1 Surfactant & Foaming Agents

65 Fillers, Diluents & Binders
49 Coating Systems & Additives
37 Direct Compression
30 Disintegrants & Superdisintegrants
25 Controlled & Modified Release
24 Lubricants & Glidants
23 Granulation
17 Thickeners and Stabilizers
17 Co-Processed Excipients
17 Taste Masking
15 Chewable & Orodispersible Aids
10 Film Formers & Plasticizers
9 Solubilizers
6 Parenteral
6 API Stability Enhancers
5 Empty Capsules
5 Coloring Agents
4 Emulsifying Agents
4 Vegetarian Capsules
3 Rheology Modifiers
2 Topical
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 29 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
29 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 64 Finished Drug Prices

2 US Medicaid Prescriptions
64 Finished Drug Prices

MARKET PLACE

18 APIs

18 APIs

PATENTS & EXCLUSIVITIES

10 US Patents

10 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

2 EDQM
1 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods, 4 Analytical Methods

1 BioAnalytical Methods
4 Analytical Methods

$ API Ref.Price (USD/KG) : 173 Xls

Filters

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Filters

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23 All

01 1ACIC Europe API & Pharmaceuticals

02 2Amoli Organics

03 1Bidachem

04 1CTX Lifesciences

05 1Chromo Laboratories

06 1Corden Pharma Bergamo S.p.A

07 1Curia

08 1HONOUR LAB LTD

09 1Industriale Chimica

10 2Ipca Laboratories

11 1Macleods Pharmaceuticals Limited

12 1Maithri Drugs

13 1Menadiona

14 1Merck Serono

15 1Novartis Pharmaceuticals Corporation

16 1Sandoz B2B

17 1Solara Active Pharma Sciences

18 1Teva API

19 1Unichem Laboratories Limited

20 1Viatris

21 1Zydus Lifesciences

filter Subject Reset all filters

23 All

01 7CHLORTHALIDONE

02 1CHLORTHALIDONE U.S.P.

03 13CHLORTHALIDONE USP

04 1CHLORTHALIDONE USP (CT6 PROCESS)

05 1CHLORTHALIDONE USP-EP

filter Country Reset all filters

23 All

01 1Cyprus

02 1Germany

03 12India

04 1Israel

05 3Italy

06 1Spain

07 2Switzerland

08 2U.S.A

filter Status Reset all filters

23 All

01 14Active

02 9Inactive

filter GDUFA DMF Review Reset all filters

23 All

01 10Complete

02 13Blank

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

List of Suppliers

Product Main Page

01

Amoli Organics Private Ltd

USDMF

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Not Confirmed

01

Amoli Organics Private Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-22

Pay. Date : 2016-08-19

DMF Number : 30551

Submission : 2016-05-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Chromo Laboratories India Private Lt...

USDMF

Formnext Forum

Not Confirmed

02

Chromo Laboratories India Private Lt...

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2024-05-20

Pay. Date : 2024-05-07

DMF Number : 33071

Submission : 2018-08-30

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

03

Curia Italy Srl

USDMF

Formnext Forum

Not Confirmed

03

Curia Italy Srl

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Digital Content

Chlorthalidone Usp-ep

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-18

Pay. Date : 2012-12-20

DMF Number : 2438

Submission : 1975-04-21

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

04

Ipca Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

04

Ipca Laboratories Ltd

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Digital Content

Chlorthalidone Usp (ct6 Process)

GDUFA

DMF Review : Complete

Rev. Date : 2014-03-31

Pay. Date : 2013-11-06

DMF Number : 27579

Submission : 2013-09-30

Status : Active

Type : II

Product Web Link

Digital Content

05

Ipca Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

05

Ipca Laboratories Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-23

Pay. Date : 2013-07-15

DMF Number : 17808

Submission : 2004-11-03

Status : Active

Type : II

Product Web Link

Digital Content

06

Macleods Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

06

Macleods Pharmaceuticals Ltd

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Digital Content

Chlorthalidone

GDUFA

DMF Review : Complete

Rev. Date : 2018-02-14

Pay. Date : 2018-01-12

DMF Number : 32207

Submission : 2017-11-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Maithri Drugs Private Ltd

USDMF

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Not Confirmed

07

Maithri Drugs Private Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2018-10-09

Pay. Date : 2018-08-03

DMF Number : 32641

Submission : 2018-03-30

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Solara Active Pharma Sciences Ltd

USDMF

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08

Solara Active Pharma Sciences Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32412

Submission : 2018-11-01

Status : Active

Type : II

Product Web Link

Digital Content

09

Unichem Laboratories Ltd

USDMF

Formnext Forum

Not Confirmed

09

Unichem Laboratories Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : Complete

Rev. Date : 2017-10-05

Pay. Date : 2017-09-15

DMF Number : 32037

Submission : 2017-09-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Tianish Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

10

Tianish Laboratories Private Ltd

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Digital Content

Chlorthalidone Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32291

Submission : 2017-12-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
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Prestwick3_000351 Manufacturers | Traders | Suppliers

Prestwick3_000351 Manufacturers, Traders, Suppliers 1

26

We have 21 companies offering Prestwick3_000351

Get in contact with the supplier of your choice:

ACIC Europe API & Pharmaceuticals
Amoli Organics
Bidachem
Chromo Laboratories
Corden Pharma Bergamo S.p.A
CTX Lifesciences
Curia
HONOUR LAB LTD
Industriale Chimica
Ipca Laboratories
Macleods Pharmaceuticals Limited
Maithri Drugs
Menadiona
Merck Serono
Novartis Pharmaceuticals Corporation
Sandoz B2B
Solara Active Pharma Sciences
Teva API
Unichem Laboratories Limited
Viatris
Zydus Lifesciences

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