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List of Drug Master Files (DMF) of Prestwick3_000418 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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Prestwick3_000418
USDMF

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Prestwick3_000418

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 6 USDMF, 1 CEP/COS, 2 JDMF, 1 KDMF, 4 NDC API, 13 Listed Suppliers, $ API Reference Price

20 API Suppliers
6 USDMF
1 CEP/COS
2 JDMF
1 KDMF
4 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 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

89 FDF Dossiers, 15 FDA Orange Book, 13 Europe, 20 Canada, 21 South Africa, 20 Listed Dossiers

89 FDF Dossiers
15 FDA Orange Book
13 Europe
20 Canada
21 South Africa
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL, INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

RELATED EXCIPIENT COMPANIES

12 Evonik, 8 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 15 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 2 Kewpie Corporation, 14 Nanjing Well Pharmaceutical, 4 Pfanstiehl, 4 ACG Worldwide, 17 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 42 BASF, 1 Bioplus Life Sciences, 1 Clariant, 15 Corel Pharma Chem, 3 DFE Pharma, 2 Finar, 17 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 21 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 5 Lubrizol Life Science Health, 20 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 14 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 21 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 63 Topical, 61 Coating Systems & Additives, 54 Thickeners and Stabilizers, 52 Solubilizers, 47 Direct Compression, 43 Parenteral, 38 Controlled & Modified Release, 35 Disintegrants & Superdisintegrants, 32 Taste Masking, 31 Granulation, 27 Lubricants & Glidants, 27 Film Formers & Plasticizers, 21 Chewable & Orodispersible Aids, 21 Co-Processed Excipients, 20 Emulsifying Agents, 11 Rheology Modifiers, 10 Surfactant & Foaming Agents, 10 API Stability Enhancers, 9 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

92 Fillers, Diluents & Binders
63 Topical
61 Coating Systems & Additives
54 Thickeners and Stabilizers
52 Solubilizers
47 Direct Compression
43 Parenteral
38 Controlled & Modified Release
35 Disintegrants & Superdisintegrants
32 Taste Masking
31 Granulation
27 Lubricants & Glidants
27 Film Formers & Plasticizers
21 Chewable & Orodispersible Aids
21 Co-Processed Excipients
20 Emulsifying Agents
11 Rheology Modifiers
10 Surfactant & Foaming Agents
10 API Stability Enhancers
9 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 3 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
3 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

11 Finished Drug Prices

11 Finished Drug Prices

MARKET PLACE

39 APIs, 2 FDF Dossiers

39 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 583 Xls

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6 All

01 1Cyclo Industries

02 1F. Hoffmann-La Roche

03 1Royal DSM

04 2SIGMA TAU

05 1Blank

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6 All

01 4BIOTIN

02 1N-HYDROXYSUCCINIMIDOBIOTIN - PRODUCT NO. H 1759 FD

03 1d-BIOTIN

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6 All

01 1Netherlands

02 1Switzerland

03 3U.S.A

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6 All

01 2Active

02 4Inactive

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01 1Complete

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

List of Suppliers

Product Main Page

01

Cyclo Products Inc

USDMF

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01

Cyclo Products Inc

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 8820

Submission : 1990-11-09

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Hoffmann La Roche Inc

USDMF

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Not Confirmed

02

Hoffmann La Roche Inc

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 3054

Submission : 1977-11-17

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Dsm Nutritional Products Ltd

USDMF

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03

Dsm Nutritional Products Ltd

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2017-02-01

Pay. Date : 2017-01-10

DMF Number : 30157

Submission : 2016-01-13

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

04

Sigma F And D Div Ltd

USDMF

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04

Sigma F And D Div Ltd

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Digital Content

N-hydroxysuccinimidobiotin - Product No. H 175...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9706

Submission : 1992-05-18

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Sigma F And D Div Ltd

USDMF

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05

Sigma F And D Div Ltd

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4529

Submission : 1982-05-05

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Zhejiang Kingland Pharmaceutical Co ...

Country

USDMF

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06

Zhejiang Kingland Pharmaceutical Co ...

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39548

Submission : 2024-02-18

Status : Active

Type : II

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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Prestwick3_000418 Manufacturers | Traders | Suppliers

Prestwick3_000418 Manufacturers, Traders, Suppliers 1

73

We have 4 companies offering Prestwick3_000418

Get in contact with the supplier of your choice:

Cyclo Industries
F. Hoffmann-La Roche
Royal DSM
SIGMA TAU

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