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List of Drug Master Files (DMF) of Prestwick2_000881 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Product

Prestwick2_000881
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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Prestwick2_000881

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 9 USDMF, 3 CEP/COS, 1 JDMF, 5 EU WC, 4 NDC API, 10 Listed Suppliers, $ API Reference Price

21 API Suppliers
9 USDMF
3 CEP/COS
1 JDMF
5 EU WC
4 NDC API
10 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

FINISHED DOSAGE FORMULATIONS

81 FDF Dossiers, 54 FDA Orange Book, 4 Europe, 1 Canada, 2 South Africa, 20 Listed Dossiers

81 FDF Dossiers
54 FDA Orange Book
4 Europe
1 Canada
2 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 14 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 15 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 17 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 50 Thickeners and Stabilizers, 47 Direct Compression, 45 Controlled & Modified Release, 41 Solubilizers, 39 Taste Masking, 30 Granulation, 29 Topical, 29 Parenteral, 29 Lubricants & Glidants, 28 Film Formers & Plasticizers, 26 Disintegrants & Superdisintegrants, 23 Chewable & Orodispersible Aids, 22 Co-Processed Excipients, 14 Emulsifying Agents, 13 Rheology Modifiers, 11 API Stability Enhancers, 9 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

111 Fillers, Diluents & Binders
75 Coating Systems & Additives
50 Thickeners and Stabilizers
47 Direct Compression
45 Controlled & Modified Release
41 Solubilizers
39 Taste Masking
30 Granulation
29 Topical
29 Parenteral
29 Lubricants & Glidants
28 Film Formers & Plasticizers
26 Disintegrants & Superdisintegrants
23 Chewable & Orodispersible Aids
22 Co-Processed Excipients
14 Emulsifying Agents
13 Rheology Modifiers
11 API Stability Enhancers
9 Empty Capsules
7 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices

3 US Medicaid Prescriptions
11 Finished Drug Prices

MARKET PLACE

17 APIs, 1 Intermediates

17 APIs
1 Intermediates

PATENTS & EXCLUSIVITIES

12 Health Canada Patents

12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 2 JP, 4 Others

2 EDQM
4 USP
2 JP
4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 6 Xls

Filters

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Filters

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9 All

01 1Aarti Drugs

02 1Divis Laboratories

03 1F. Hoffmann-La Roche

04 1Jubilant Generics

05 2Lonza Group

06 1Upsher-Smith Laboratories

07 1Vertellus

08 1Wockhardt

filter Subject Reset all filters

9 All

01 2NIACIN

02 3NIACIN USP

03 1NIACIN USP GRANULAR SPECIAL

04 1NIACIN USP SPECIAL

05 1NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS)

06 1NICOTINIC ACID CAPSULES 125,250, & 500MG

filter Country Reset all filters

9 All

01 4India

02 3Switzerland

03 2U.S.A

filter Status Reset all filters

9 All

01 4Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

9 All

01 3Complete

02 6Blank

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

List of Suppliers

Product Main Page

01

Aarti Drugs Ltd

USDMF

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Not Confirmed

01

Aarti Drugs Ltd

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Not Confirmed

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-10

Pay. Date : 2013-04-03

DMF Number : 20051

Submission : 2006-12-14

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Divis Laboratories Ltd

USDMF

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Not Confirmed

02

Divis Laboratories Ltd

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-08

Pay. Date : 2012-12-06

DMF Number : 18481

Submission : 2005-07-05

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

03

Kv Pharmaceutical Co

USDMF

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Not Confirmed

03

Kv Pharmaceutical Co

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Digital Content

Nicotinic Acid Capsules 125,250, & 500mg

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4404

Submission : 1982-01-12

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Jubilant Pharmova Ltd

USDMF

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Not Confirmed

04

Jubilant Pharmova Ltd

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 31382

Submission : 2017-03-29

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Lonza Ltd

USDMF

Formnext Forum

Not Confirmed

05

Lonza Ltd

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Digital Content

Niacin Usp Granular Special

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18293

Submission : 2005-04-11

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Lonza Ag

USDMF

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Not Confirmed

06

Lonza Ag

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Digital Content

Niacin Usp Special

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8041

Submission : 1989-04-14

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Upsher Smith Laboratories Inc

USDMF

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Not Confirmed

07

Upsher Smith Laboratories Inc

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Digital Content

Niacor (immediate-release Niacin Tablets)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10523

Submission : 1993-10-07

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Aurorium Llc

USDMF

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Not Confirmed

08

Aurorium Llc

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2022-09-12

Pay. Date : 2022-09-28

DMF Number : 8259

Submission : 1989-10-17

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Wockhardt Ltd

USDMF

Formnext Forum

Not Confirmed

09

Wockhardt Ltd

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Not Confirmed

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7642

Submission : 1988-08-23

Status : Inactive

Type : II

Product Web Link

Digital Content

Prestwick2_000881 Manufacturers | Traders | Suppliers

Prestwick2_000881 Manufacturers, Traders, Suppliers 1

76

We have 8 companies offering Prestwick2_000881

Get in contact with the supplier of your choice:

Aarti Drugs
Divis Laboratories
F. Hoffmann-La Roche
Jubilant Generics
Lonza Group
Upsher-Smith Laboratories
Vertellus
Wockhardt

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