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List of Drug Master Files (DMF) of Prestwick3_000052 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000052
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_000052

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 22 USDMF, 17 CEP/COS, 7 JDMF, 8 EU WC, 10 KDMF, 20 NDC API, 30 Listed Suppliers, $ API Reference Price

61 API Suppliers
22 USDMF
17 CEP/COS
7 JDMF
8 EU WC
10 KDMF
20 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

289 FDF Dossiers, 91 FDA Orange Book, 91 Europe, 16 Canada, 17 Australia, 16 South Africa, 58 Listed Dossiers

289 FDF Dossiers
91 FDA Orange Book
91 Europe
16 Canada
17 Australia
16 South Africa
58 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 400MG, SOLUTION;INTRAVENOUS - 200MG/20ML (10MG/ML), CAPSULE, EXTENDED RELEASE;ORAL - 100MG, CAPSULE, EXTENDED RELEASE;ORAL - 200MG, CAPSULE, EXTENDED RELEASE;ORAL - 300MG

TABLET;ORAL - 200MG
TABLET, EXTENDED RELEASE;ORAL - 100MG
TABLET, EXTENDED RELEASE;ORAL - 200MG
TABLET, EXTENDED RELEASE;ORAL - 400MG
SOLUTION;INTRAVENOUS - 200MG/20ML (10MG/ML)
CAPSULE, EXTENDED RELEASE;ORAL - 100MG
CAPSULE, EXTENDED RELEASE;ORAL - 200MG
CAPSULE, EXTENDED RELEASE;ORAL - 300MG

RELATED EXCIPIENT COMPANIES

2 Evonik, 4 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 10 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 16 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 10 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

91 Fillers, Diluents & Binders, 64 Coating Systems & Additives, 43 Controlled & Modified Release, 42 Direct Compression, 34 Thickeners and Stabilizers, 30 Disintegrants & Superdisintegrants, 30 Granulation, 27 Taste Masking, 24 Solubilizers, 24 Film Formers & Plasticizers, 21 Parenteral, 20 Topical, 19 Lubricants & Glidants, 17 Co-Processed Excipients, 16 Chewable & Orodispersible Aids, 12 Emulsifying Agents, 9 Empty Capsules, 7 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Dry Powder Inhalation, 1 Soft Gelatin

91 Fillers, Diluents & Binders
64 Coating Systems & Additives
43 Controlled & Modified Release
42 Direct Compression
34 Thickeners and Stabilizers
30 Disintegrants & Superdisintegrants
30 Granulation
27 Taste Masking
24 Solubilizers
24 Film Formers & Plasticizers
21 Parenteral
20 Topical
19 Lubricants & Glidants
17 Co-Processed Excipients
16 Chewable & Orodispersible Aids
12 Emulsifying Agents
9 Empty Capsules
7 API Stability Enhancers
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Dry Powder Inhalation
1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 33 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
33 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

5 US Medicaid Prescriptions, 67 Finished Drug Prices, 1 Annual Reports

5 US Medicaid Prescriptions
67 Finished Drug Prices
1 Annual Reports

MARKET PLACE

28 APIs, 15 FDF Dossiers

28 APIs
15 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents

12 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 15 Others

2 EDQM
3 USP
15 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 137 Xls

Filters

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Filters

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22 All

01 1Polpharma

02 1Taro Pharmaceutical Industries

03 1American Chemical Products

04 1Amoli Organics

05 1CTX Lifesciences

06 1Corden Pharma Bergamo S.p.A

07 1DMFs Not Supported

08 1Dasami Lab

09 1F.I.S. Fabbrica Italiana Sintetici

10 1Jubilant Generics

11 1RP SCHERER GMBH & CO. KG

12 1Recordati

13 1SAFC

14 2Siegfried AG

15 2Teva API

16 2Zhejiang Jiuzhou Pharmaceutical

17 3Blank

filter Subject Reset all filters

22 All

01 8CARBAMAZEPINE

02 1CARBAMAZEPINE (CARBATOL)

03 1CARBAMAZEPINE BULK DRUG SUBSTANCE

04 1CARBAMAZEPINE PROCESS B

05 8CARBAMAZEPINE USP

06 1CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL RESEARCH

07 1DIETHYL CARBAMAZINE

08 1TEGRETOL S.R. CAPSULES

filter Country Reset all filters

22 All

01 2China

02 1Germany

03 4India

04 2Israel

05 3Italy

06 1Poland

07 2Switzerland

08 3U.S.A

09 4Blank

filter Status Reset all filters

22 All

01 11Active

02 11Inactive

filter GDUFA DMF Review Reset all filters

22 All

01 7Complete

02 15Blank

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

List of Suppliers

Product Main Page

01

Zaklady Farmaceutyczne Polpharma Sa

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

Digital Content

Carbamazepine

GDUFA

DMF Review : Complete

Rev. Date : 2015-12-16

Pay. Date : 2015-06-25

DMF Number : 26266

Submission : 2012-07-31

Status : Active

Type : II

Product Web Link

Digital Content

02

Taro Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4929

Submission : 1983-03-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Amoli Organics Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

03

Amoli Organics Pvt Ltd

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-27

Pay. Date : 2013-01-15

DMF Number : 23170

Submission : 2009-10-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Ctx Life Sciences Pvt Ltd

USDMF

Formnext Forum

Not Confirmed

04

Ctx Life Sciences Pvt Ltd

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-07

Pay. Date : 2013-02-15

DMF Number : 24195

Submission : 2010-09-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Fis Fabbrica Italiana Sintetici Spa

USDMF

Formnext Forum

Not Confirmed

05

Fis Fabbrica Italiana Sintetici Spa

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6641

Submission : 1986-10-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Jubilant Pharmova Ltd

USDMF

Formnext Forum

Not Confirmed

06

Jubilant Pharmova Ltd

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-01

Pay. Date : 2014-07-25

DMF Number : 14410

Submission : 1999-09-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Siegfried Evionnaz Sa

USDMF

Formnext Forum

Not Confirmed

07

Siegfried Evionnaz Sa

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine (carbatol)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15195

Submission : 2000-12-04

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

08

Siegfried Evionnaz Sa

USDMF

Formnext Forum

Not Confirmed

08

Siegfried Evionnaz Sa

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4341

Submission : 1981-11-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

09

Teva Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

09

Teva Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Carbamazepine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-30

Pay. Date : 2012-11-13

DMF Number : 4719

Submission : 1982-11-10

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Raybow Pharmaceutical Co Lt...

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Raybow Pharmaceutical Co Lt...

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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Post an Enquiry

Digital Content

Carbamazepine Process B

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-03

Pay. Date : 2013-11-29

DMF Number : 27261

Submission : 2013-06-21

Status : Active

Type : IV

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
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Prestwick3_000052 Manufacturers | Traders | Suppliers

Prestwick3_000052 Manufacturers, Traders, Suppliers 1

93

We have 15 companies offering Prestwick3_000052

Get in contact with the supplier of your choice:

Polpharma
Taro Pharmaceutical Industries
American Chemical Products
Amoli Organics
Corden Pharma Bergamo S.p.A
CTX Lifesciences
Dasami Lab
F.I.S. Fabbrica Italiana Sintetici
Jubilant Generics
Recordati
RP SCHERER GMBH & CO. KG
SAFC
Siegfried AG
Teva API
Zhejiang Jiuzhou Pharmaceutical

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