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List of Drug Master Files (DMF) of Prestwick3_000316 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000316
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_000316

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 15 USDMF, 9 CEP/COS, 4 JDMF, 6 EU WC, 1 KDMF, 6 NDC API, 13 Listed Suppliers, $ API Reference Price

25 API Suppliers
15 USDMF
9 CEP/COS
4 JDMF
6 EU WC
1 KDMF
6 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 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

9 API Suppliers

9 API Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers, 83 FDA Orange Book, 26 Europe, 7 Canada, 2 Australia, 19 South Africa, 43 Listed Dossiers

180 FDF Dossiers
83 FDA Orange Book
26 Europe
7 Canada
2 Australia
19 South Africa
43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 1.25MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1.25MG
TABLET;ORAL - 2.5MG
TABLET;ORAL - 5MG
TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 7 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 27 BASF, 2 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 6 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 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, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

86 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 43 Direct Compression, 37 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 30 Solubilizers, 26 Granulation, 26 Thickeners and Stabilizers, 21 Film Formers & Plasticizers, 20 Co-Processed Excipients, 19 Lubricants & Glidants, 18 Topical, 14 Parenteral, 11 Taste Masking, 9 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

86 Fillers, Diluents & Binders
49 Coating Systems & Additives
43 Direct Compression
37 Controlled & Modified Release
30 Disintegrants & Superdisintegrants
30 Solubilizers
26 Granulation
26 Thickeners and Stabilizers
21 Film Formers & Plasticizers
20 Co-Processed Excipients
19 Lubricants & Glidants
18 Topical
14 Parenteral
11 Taste Masking
9 Emulsifying Agents
8 Chewable & Orodispersible Aids
6 API Stability Enhancers
5 Empty Capsules
5 Surfactant & Foaming Agents
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 22 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
22 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 33 Finished Drug Prices

2 US Medicaid Prescriptions
33 Finished Drug Prices

MARKET PLACE

14 APIs, 5 FDF Dossiers

14 APIs
5 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 Others

4 EDQM
3 USP
4 Others

$ API Ref.Price (USD/KG) : 85 Xls

Filters

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15 All

01 1USV Private Limited

02 1Aurobindo Pharma Limited

03 2Cadila Pharmaceuticals

04 1Cambrex Corporation

05 1Celanese

06 1Dipharma

07 1Lusochimica

08 1Sri Krishna Pharmaceuticals

09 1TIANJIN GENCOM PHARMACEUTICAL CO LTD

10 1Trifarma

11 1Zentiva

12 1Zydus Lifesciences

13 2Blank

filter Subject Reset all filters

15 All

01 1GILBENCLAMIDE/GLYBURIDE

02 1GLIBENCLAMIDE (GLYBURIDE)

03 1GLIBENCLAMIDE/GLYBURIDE

04 6GLYBURIDE

05 1GLYBURIDE BP'88 (GLIBENCLAMIDE)

06 4GLYBURIDE USP

07 1GLYBURIDE USP (GLIBENCLAMIDE), MILLED

filter Country Reset all filters

15 All

01 1China

02 1Czech Republic

03 6India

04 3Italy

05 2U.S.A

06 2Blank

filter Status Reset all filters

15 All

01 9Active

02 6Inactive

filter GDUFA DMF Review Reset all filters

15 All

01 3Complete

02 12Blank

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

List of Suppliers

Product Main Page

01

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

Glyburide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-09-28

Pay. Date : 2013-09-23

DMF Number : 15821

Submission : 2002-01-24

Status : Active

Type : II

USV Private Limited

Portfolio PDF

Product Web Link

Digital Content

02

Apitoria Pharma Private Ltd

USDMF

AAPS 2024

Not Confirmed

02

Apitoria Pharma Private Ltd

AAPS 2024

Not Confirmed

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Digital Content

Glyburide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17152

Submission : 2004-01-20

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

03

Cadila Pharmaceuticals Ltd

USDMF

AAPS 2024

Not Confirmed

03

Cadila 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.

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Digital Content

Glyburide Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-10-05

Pay. Date : 2013-09-26

DMF Number : 17093

Submission : 2004-01-14

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

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7675

Submission : 1988-09-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Dipharma Francis Srl

USDMF

AAPS 2024

Not Confirmed

05

Dipharma Francis 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.

Post an Enquiry

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Digital Content

Gilbenclamide/glyburide

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7678

Submission : 1988-09-16

Status : Active

Type : II

Product Web Link

Digital Content

06

Lusochimica Spa

USDMF

AAPS 2024

Not Confirmed

06

Lusochimica 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

Glibenclamide (glyburide)

GDUFA

DMF Review : Complete

Rev. Date : 2013-06-06

Pay. Date : 2013-05-23

DMF Number : 9430

Submission : 1991-12-03

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

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

Glyburide Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27045

Submission : 2013-04-19

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

08

Tianjin Pharmaceutical Holdings Genc...

USDMF

AAPS 2024

Not Confirmed

08

Tianjin Pharmaceutical Holdings Genc...

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 : 29921

Submission : 2015-10-08

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Zentiva Ks

USDMF

AAPS 2024

Not Confirmed

09

Zentiva Ks

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

Glyburide Usp (glibenclamide), Milled

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18018

Submission : 2005-01-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Farmos Group Ltd Medipolar

Country

USDMF

AAPS 2024

Not Confirmed

10

Farmos Group Ltd Medipolar

Country

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

Country

Virtual Booth

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7638

Submission : 1988-08-15

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

1
2

Prestwick3_000316 Manufacturers | Traders | Suppliers

Prestwick3_000316 Manufacturers, Traders, Suppliers 1

100

We have 12 companies offering Prestwick3_000316

Get in contact with the supplier of your choice:

USV Private Limited
Aurobindo Pharma Limited
Cadila Pharmaceuticals
Cambrex Corporation
Celanese
Dipharma
Lusochimica
Sri Krishna Pharmaceuticals
TIANJIN GENCOM PHARMACEUTICAL CO LTD
Trifarma
Zentiva
Zydus Lifesciences

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