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List of Drug Master Files (DMF) of Prestwick3_000131 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000131
USDMF

Renejix: CDMO with expertise in small molecule oral dosage, delivery tech, and multi-modality manufacturing.

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SPI Pharma has been solving formulation challenges using superior functional materials.

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xyz-pharma-m-2024-10-07

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Ribobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2024-10-07

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Prestwick3_000131

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 17 USDMF, 5 CEP/COS, 4 EU WC, 16 NDC API, 19 Listed Suppliers, $ API Reference Price

29 API Suppliers
17 USDMF
5 CEP/COS
4 EU WC
16 NDC API
19 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

INTERMEDIATES

8 API Suppliers

8 API Suppliers

FINISHED DOSAGE FORMULATIONS

101 FDF Dossiers, 73 FDA Orange Book, 4 Europe, 4 Australia, 1 South Africa, 19 Listed Dossiers

101 FDF Dossiers
73 FDA Orange Book
4 Europe
4 Australia
1 South Africa
19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 10MG, TABLET, EXTENDED RELEASE;ORAL - 2.5MG, TABLET, EXTENDED RELEASE;ORAL - 5MG

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 5 SPI Pharma, 2 Seqens, 14 DKSH, 3 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 32 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 15 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 21 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

88 Fillers, Diluents & Binders, 76 Coating Systems & Additives, 45 Controlled & Modified Release, 37 Direct Compression, 35 Disintegrants & Superdisintegrants, 33 Solubilizers, 31 Thickeners and Stabilizers, 29 Lubricants & Glidants, 25 Granulation, 25 Topical, 21 Co-Processed Excipients, 21 Film Formers & Plasticizers, 18 Parenteral, 11 Taste Masking, 9 Emulsifying Agents, 8 Rheology Modifiers, 8 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

88 Fillers, Diluents & Binders
76 Coating Systems & Additives
45 Controlled & Modified Release
37 Direct Compression
35 Disintegrants & Superdisintegrants
33 Solubilizers
31 Thickeners and Stabilizers
29 Lubricants & Glidants
25 Granulation
25 Topical
21 Co-Processed Excipients
21 Film Formers & Plasticizers
18 Parenteral
11 Taste Masking
9 Emulsifying Agents
8 Rheology Modifiers
8 Chewable & Orodispersible Aids
7 API Stability Enhancers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules

DIGITAL CONTENT

20 NEWS #PharmaBuzz

20 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 13 Finished Drug Prices

2 US Medicaid Prescriptions
13 Finished Drug Prices

MARKET PLACE

5 APIs, 2 FDF Dossiers

5 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Exclusivities, 2 Health Canada Patents

1 US Exclusivities
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 EDQM, 2 USP, 13 Others

5 EDQM
2 USP
13 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 277 Xls

Filters

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17 All

01 1Fermion Oy

02 1USV Private Limited

03 1Abbott Laboratories

04 1Amsa Spa

05 1Cambrex Corporation

06 1China Chemical & Pharmaceutical

07 1J.B.Chemicals & Pharmaceuticals

08 1Kreative Organics

09 1Lupin Ltd

10 1Olon S.p.A

11 1Pfizer Inc

12 1Sri Krishna Pharmaceuticals

13 1Sumitomo Chemical

14 1Taizhou Highsun Pharmaceutical Co.,Ltd.

15 1Unichem Laboratories Limited

16 1Urquima S.A. Grupo Uriach

17 1Blank

filter Subject Reset all filters

17 All

01 9GLIPIZIDE

02 7GLIPIZIDE USP

03 1GLIPIZIDE USP, NON-STERILE DRUG SUBSTANCE

filter Country Reset all filters

17 All

01 2China

02 1Finland

03 6India

04 2Italy

05 1Japan

06 1Spain

07 3U.S.A

08 1Blank

filter Status Reset all filters

17 All

01 12Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

17 All

01 7Complete

02 10Blank

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

List of Suppliers

Product Main Page

01

Fermion Oy

Bio-Europe 2024

With Fermion, start the journey of your innovative API.

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2020-06-12

Pay. Date : 2020-06-05

DMF Number : 15174

Submission : 2000-12-04

Status : Active

Type : II

Product Web Link

Digital Content

02

Usv Private Ltd

CPhI India 2024

USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

Contact Supplier

Contact Supplier

Digital Content

Glipizide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12374

Submission : 1997-02-24

Status : Active

Type : II

USV Private Limited

Portfolio PDF

Product Web Link

Digital Content

03

Amsa Spa

USDMF

AAPS 2024

Not Confirmed

03

Amsa Spa

AAPS 2024

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 : Complete

Rev. Date : 2014-03-21

Pay. Date : 2013-09-23

DMF Number : 13101

Submission : 1998-07-30

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cambrex Profarmaco Milano Srl

USDMF

AAPS 2024

Not Confirmed

04

Cambrex Profarmaco Milano Srl

AAPS 2024

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 : 7710

Submission : 1988-10-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Kreative Organics Private Ltd

USDMF

AAPS 2024

Not Confirmed

05

Kreative Organics Private Ltd

AAPS 2024

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

Glipizide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2024-04-02

Pay. Date : 2024-01-25

DMF Number : 27598

Submission : 2013-09-26

Status : Active

Type : II

Product Web Link

Digital Content

06

Pharmacia And Upjohn Co Llc Wholly O...

USDMF

AAPS 2024

Not Confirmed

06

Pharmacia And Upjohn Co Llc Wholly O...

AAPS 2024

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

Glipizide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2418

Submission : 1975-02-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Sri Krishna Pharmaceuticals Ltd

USDMF

AAPS 2024

Not Confirmed

07

Sri Krishna Pharmaceuticals Ltd

AAPS 2024

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

Glipizide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2015-08-04

Pay. Date : 2014-08-07

DMF Number : 25993

Submission : 2012-05-07

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Taizhou Highsun Pharmaceutical Co Lt...

China

USDMF

AAPS 2024

Not Confirmed

08

Taizhou Highsun Pharmaceutical Co Lt...

China

AAPS 2024

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

China

Digital Content

Glipizide Usp, Non-sterile Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19580

Submission : 2006-07-02

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Unichem Laboratories Ltd

USDMF

AAPS 2024

Not Confirmed

09

Unichem Laboratories Ltd

AAPS 2024

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

Glipizide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-05

Pay. Date : 2014-09-03

DMF Number : 28474

Submission : 2014-09-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Urquima Sa

USDMF

AAPS 2024

Not Confirmed

10

Urquima Sa

AAPS 2024

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

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10046

Submission : 1993-01-19

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Prestwick3_000131 Manufacturers | Traders | Suppliers

Prestwick3_000131 Manufacturers, Traders, Suppliers 1

17

We have 16 companies offering Prestwick3_000131

Get in contact with the supplier of your choice:

Fermion Oy
USV Private Limited
Abbott Laboratories
Amsa Spa
Cambrex Corporation
China Chemical & Pharmaceutical
J.B.Chemicals & Pharmaceuticals
Kreative Organics
Lupin Ltd
Olon S.p.A
Pfizer Inc
Sri Krishna Pharmaceuticals
Sumitomo Chemical
Taizhou Highsun Pharmaceutical Co.,Ltd.
Unichem Laboratories Limited
Urquima S.A. Grupo Uriach

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