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List of Drug Master Files (DMF) of Prestwick3_000717 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

Client Email

Product

Prestwick3_000717
USDMF

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Prestwick3_000717

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 12 USDMF, 11 CEP/COS, 5 JDMF, 8 EU WC, 31 KDMF, 20 NDC API, 21 Listed Suppliers, $ API Reference Price

30 API Suppliers
12 USDMF
11 CEP/COS
5 JDMF
8 EU WC
31 KDMF
20 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 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

247 FDF Dossiers, 24 FDA Orange Book, 135 Europe, 25 Canada, 20 Australia, 11 South Africa, 32 Listed Dossiers

247 FDF Dossiers
24 FDA Orange Book
135 Europe
25 Canada
20 Australia
11 South Africa
32 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 5MG, TABLET;ORAL - 1MG

TABLET;ORAL - 5MG
TABLET;ORAL - 1MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 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, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 35 Direct Compression, 30 Disintegrants & Superdisintegrants, 30 Controlled & Modified Release, 26 Solubilizers, 24 Granulation, 23 Thickeners and Stabilizers, 20 Topical, 19 Co-Processed Excipients, 18 Lubricants & Glidants, 17 Parenteral, 16 Film Formers & Plasticizers, 9 Taste Masking, 9 Emulsifying Agents, 6 API Stability Enhancers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 19 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 122 Finished Drug Prices, 9 Annual Reports

2 US Medicaid Prescriptions
122 Finished Drug Prices
9 Annual Reports

MARKET PLACE

20 APIs, 9 FDF Dossiers

20 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

7 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 1 Others

2 EDQM
1 USP
1 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 3,017 Xls

Filters

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Filters

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12 All

01 2Hubei Gedian Humanwell Pharmaceutical

02 1Dr. Reddy\'s Laboratories

03 1Aurobindo Pharma Limited

04 2Cipla

05 1Gedeon Richter

06 1Hetero Drugs

07 1MSN Laboratories

08 1Sterling Spa

09 1Sun Pharmaceutical Industries Limited

10 1YUAN XINYAN

filter Subject Reset all filters

12 All

01 1DIHYDROFINASTERIDE

02 3FINASTERIDE

03 1FINASTERIDE (API)

04 6FINASTERIDE USP

05 1FINASTERIDE USP (FORM III)

filter Country Reset all filters

12 All

01 2China

02 1Hungary

03 7India

04 1Italy

05 1Blank

filter Status Reset all filters

12 All

01 9Active

02 3Inactive

filter GDUFA DMF Review Reset all filters

12 All

01 4Complete

02 8Blank

Hubei Gedian Humanwell Pharmaceutical Finasteride

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

List of Suppliers

Product Main Page

01

Hubei Gedian Humanwell Pharmaceutica...

CPhI Worldwide, Milan

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

Contact Supplier

Digital Content

Finasteride

GDUFA

DMF Review : Complete

Rev. Date : 2022-09-27

Pay. Date : 2022-08-04

DMF Number : 25056

Submission : 2011-06-17

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

Product Web Link

Digital Content

02

Dr Reddys Laboratories Ltd

CPhI Worldwide, Milan

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Contact Supplier

Contact Supplier

Digital Content

Finasteride Usp (form Iii)

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16010

Submission : 2002-06-11

Status : Active

Type : II

Dr Reddy Company Banner

Product Web Link

Digital Content

03

Hubei Gedian Humanwell Pharmaceutica...

CPhI Worldwide, Milan

Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.

Contact Supplier

Contact Supplier

Digital Content

Dihydrofinasteride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 29764

Submission : 2015-09-20

Status : Active

Type : II

Hubei Gedian Humanwell Pharmaceutical

Product Web Link

Digital Content

04

Apitoria Pharma Private Ltd

USDMF

Formnext Forum

Not Confirmed

04

Apitoria Pharma Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Finasteride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-02-27

Pay. Date : 2013-01-22

DMF Number : 19308

Submission : 2006-03-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

05

Cipla Ltd

USDMF

Formnext Forum

Not Confirmed

05

Cipla Ltd

Formnext Forum

Not Confirmed

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Digital Content

Finasteride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 15778

Submission : 2001-12-28

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Gedeon Richter Plc

USDMF

Formnext Forum

Not Confirmed

06

Gedeon Richter Plc

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Not Confirmed

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Digital Content

Finasteride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17575

Submission : 2004-07-26

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Hetero Labs Ltd

USDMF

Formnext Forum

Not Confirmed

07

Hetero Labs Ltd

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Not Confirmed

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Digital Content

Finasteride

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-16

Pay. Date : 2014-05-05

DMF Number : 20893

Submission : 2007-09-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Msn Laboratories Private Ltd

USDMF

Formnext Forum

Not Confirmed

08

Msn Laboratories Private Ltd

Formnext Forum

Not Confirmed

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Digital Content

Finasteride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-04-24

Pay. Date : 2012-12-05

DMF Number : 21276

Submission : 2008-01-21

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Sterling Spa

USDMF

Formnext Forum

Not Confirmed

09

Sterling Spa

Formnext Forum

Not Confirmed

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Digital Content

Finasteride

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 18483

Submission : 2005-07-06

Status : Active

Type : II

Product Web Link

Digital Content

10

Sun Pharmaceutical Industries Ltd

USDMF

Formnext Forum

Not Confirmed

10

Sun Pharmaceutical Industries Ltd

Formnext Forum

Not Confirmed

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Digital Content

Finasteride Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21300

Submission : 2008-01-24

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Prestwick3_000717 Manufacturers | Traders | Suppliers

Prestwick3_000717 Manufacturers, Traders, Suppliers 1

21

We have 10 companies offering Prestwick3_000717

Get in contact with the supplier of your choice:

Dr. Reddy\'s Laboratories
Hubei Gedian Humanwell Pharmaceutical
Aurobindo Pharma Limited
Cipla
Gedeon Richter
Hetero Drugs
MSN Laboratories
Sterling Spa
Sun Pharmaceutical Industries Limited
YUAN XINYAN

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