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Prestwick3_000316

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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

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

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

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TABLET;ORAL - 5MG, TABLET;ORAL - 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 22 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 33 Finished Drug Prices

MARKET PLACE

14 APIs, 5 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	USV Private Limited	India	USV PRIVATE LTD	15821	GLYBURIDE USP	2002-01-24	Active	II	Complete	2013-09-28	2013-09-23
26/09/2024	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	17152	GLYBURIDE USP	2004-01-20	Active	II	N/A

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

Prestwick3_000316

Prestwick3_000316

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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

DEVELOPMENTS

3 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

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

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**

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

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