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List of Drug Master Files (DMF) of Prestwick3_000478 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000478
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_000478

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 16 USDMF, 9 CEP/COS, 1 JDMF, 4 EU WC, 17 KDMF, 6 NDC API, 10 Listed Suppliers, $ API Reference Price

22 API Suppliers
16 USDMF
9 CEP/COS
1 JDMF
4 EU WC
17 KDMF
6 NDC API
10 Listed Suppliers
$ API Reference Price

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

203 FDF Dossiers, 44 FDA Orange Book, 96 Europe, 8 Canada, 22 Australia, 7 South Africa, 26 Listed Dossiers

203 FDF Dossiers
44 FDA Orange Book
96 Europe
8 Canada
22 Australia
7 South Africa
26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Minakem, 5 SPI Pharma, 2 Seqens, 3 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 3 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 21 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 3 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 14 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 34 Direct Compression, 29 Solubilizers, 29 Controlled & Modified Release, 24 Thickeners and Stabilizers, 19 Granulation, 18 Topical, 18 Co-Processed Excipients, 16 Film Formers & Plasticizers, 15 Disintegrants & Superdisintegrants, 13 Parenteral, 13 Lubricants & Glidants, 9 Emulsifying Agents, 8 API Stability Enhancers, 8 Chewable & Orodispersible Aids, 7 Taste Masking, 5 Empty Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules

63 Fillers, Diluents & Binders
46 Coating Systems & Additives
34 Direct Compression
29 Solubilizers
29 Controlled & Modified Release
24 Thickeners and Stabilizers
19 Granulation
18 Topical
18 Co-Processed Excipients
16 Film Formers & Plasticizers
15 Disintegrants & Superdisintegrants
13 Parenteral
13 Lubricants & Glidants
9 Emulsifying Agents
8 API Stability Enhancers
8 Chewable & Orodispersible Aids
7 Taste Masking
5 Empty Capsules
4 Surfactant & Foaming Agents
4 Coloring Agents
4 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

75 Finished Drug Prices, 3 Annual Reports

75 Finished Drug Prices
3 Annual Reports

MARKET PLACE

6 APIs, 2 FDF Dossiers

6 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 Health Canada Patents

10 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 2 Others

2 EDQM
1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 390 Xls

Filters

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Filters

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16 All

01 1Medichem S.A

02 1Alembic Pharmaceuticals Limited

03 1Aurobindo Pharma Limited

04 1Changzhou Ruiming Pharmaceutical

05 1Cipla

06 1Emcure Pharmaceuticals

07 1Esteve Quimica

08 1Everlight Chemical

09 1HEC Pharm

10 1Hainan Poly Pharm

11 1Korea United Pharm. Inc.

12 1Orchid Pharma

13 1Wockhardt

14 1Yangzhou Pharmaceutical

15 1Yangzhou Pharmaceutical Factory

16 1Zhejiang Supor Pharmaceuticals Co., LTD

filter Subject Reset all filters

16 All

01 7FELODIPINE

02 1FELODIPINE (NON-STERILE BULK API)

03 1FELODIPINE EXTENDED RELEASE TABLETS

04 1FELODIPINE NON-STERILE BULK DRUG SUBSTANCE

05 3FELODIPINE USP

06 1FELODIPINE USP, NON-STERILE DRUG SUBSTANCE

07 1FELODIPINE, NON-STERILE DRUG SUBSTANCE USP

08 1Felodipine USP

filter Country Reset all filters

16 All

01 6China

02 6India

03 1South Korea

04 2Spain

05 1Taiwan

filter Status Reset all filters

16 All

01 7Active

02 9Inactive

filter GDUFA DMF Review Reset all filters

16 All

01 4Complete

02 12Blank

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

List of Suppliers

Product Main Page

01

Medichem Sa

CPhI Worldwide, Milan

Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-28

Pay. Date : 2013-03-14

DMF Number : 14099

Submission : 1999-05-03

Status : Active

Type : II

Product Web Link

Digital Content

02

Alembic Pharmaceuticals Ltd

USDMF

Formnext Forum

Not Confirmed

02

Alembic Pharmaceuticals Ltd

Formnext Forum

Not Confirmed

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Post an Enquiry

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Digital Content

Felodipine Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-06-03

Pay. Date : 2013-09-27

DMF Number : 25373

Submission : 2011-10-11

Status : Active

Type : II

Product Web Link

Digital Content

03

Apitoria Pharma Private Ltd

USDMF

Formnext Forum

Not Confirmed

03

Apitoria Pharma Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Felodipine Usp, Non-sterile Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20890

Submission : 2007-09-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

04

Cipla Ltd

USDMF

Formnext Forum

Not Confirmed

04

Cipla Ltd

Formnext Forum

Not Confirmed

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Digital Content

Felodipine Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11449

Submission : 1995-04-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Esteve Quimica Sa

USDMF

Formnext Forum

Not Confirmed

05

Esteve Quimica Sa

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12248

Submission : 1996-12-04

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Everlight Chemical Industrial Corp

USDMF

Formnext Forum

Not Confirmed

06

Everlight Chemical Industrial Corp

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.

Post an Enquiry

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2015-10-05

Pay. Date : 2015-09-24

DMF Number : 17030

Submission : 2003-12-10

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

07

Orbion Pharmaceuticals Private Ltd

USDMF

Formnext Forum

Not Confirmed

07

Orbion Pharmaceuticals 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.

Post an Enquiry

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Digital Content

Felodipine (non-sterile Bulk Api)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21354

Submission : 2008-04-02

Status : Active

Type : II

Product Web Link

Digital Content

08

Wockhardt Ltd

USDMF

Formnext Forum

Not Confirmed

08

Wockhardt 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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 13255

Submission : 1998-10-02

Status : Inactive

Type : II

Product Web Link

Digital Content

09

Yangzhou Pharmaceutical Factory

USDMF

Formnext Forum

Not Confirmed

09

Yangzhou Pharmaceutical Factory

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.

Post an Enquiry

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14786

Submission : 2000-03-16

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Zhejiang Supor Pharmaceuticals Co Lt...

USDMF

Formnext Forum

Not Confirmed

10

Zhejiang Supor Pharmaceuticals 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.

Post an Enquiry

Post an Enquiry

Digital Content

Felodipine, Non-sterile Drug Substance Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-11-18

Pay. Date : 2013-09-03

DMF Number : 19449

Submission : 2006-05-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Prestwick3_000478 Manufacturers | Traders | Suppliers

Prestwick3_000478 Manufacturers, Traders, Suppliers 1

22

We have 16 companies offering Prestwick3_000478

Get in contact with the supplier of your choice:

Medichem S.A
Alembic Pharmaceuticals Limited
Aurobindo Pharma Limited
Changzhou Ruiming Pharmaceutical
Cipla
Emcure Pharmaceuticals
Esteve Quimica
Everlight Chemical
Hainan Poly Pharm
HEC Pharm
Korea United Pharm. Inc.
Orchid Pharma
Wockhardt
Yangzhou Pharmaceutical
Yangzhou Pharmaceutical Factory
Zhejiang Supor Pharmaceuticals Co., LTD

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