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

Client Email

Product

Estradiol
Estradiol Acetate
Estradiol Valerate
Ethinyl Estradiol
Estradiol Benzoate
Estradiol Cypionate
Estradiol Enanthate
2-Methoxyestradiol
Estrone
CAS 50-28-2
USDMF

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Estradiol

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

30 API Suppliers, 11 USDMF, 9 CEP/COS, 2 JDMF, 2 EU WC, 10 KDMF, 33 NDC API, 4 VMF, 17 Listed Suppliers, $ API Reference Price

30 API Suppliers
11 USDMF
9 CEP/COS
2 JDMF
2 EU WC
10 KDMF
33 NDC API
4 VMF
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

39 Drugs in Development

39 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

1 API Suppliers

1 API Suppliers

FINISHED DOSAGE FORMULATIONS

534 FDF Dossiers, 223 FDA Orange Book, 222 Europe, 29 Canada, 23 Australia, 27 South Africa, 10 Listed Dossiers

534 FDF Dossiers
223 FDA Orange Book
222 Europe
29 Canada
23 Australia
27 South Africa
10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR, INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR, SYSTEM;TRANSDERMAL - 0.025MG/24HR, SYSTEM;TRANSDERMAL - 0.0375MG/24HR, SYSTEM;TRANSDERMAL - 0.05MG/24HR, SYSTEM;TRANSDERMAL - 0.075MG/24HR, SYSTEM;TRANSDERMAL - 0.1MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;VAGINAL - 10MCG, TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 0.5MG;100MG, CAPSULE;ORAL - 1MG;100MG, GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION), FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 0.25MG;0.5MG, TABLET;ORAL - 0.5MG;1MG, GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION), SPRAY;TRANSDERMAL - 1.53MG/SPRAY, GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET), GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET), GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET), GEL;TRANSDERMAL - 0.1% (1GM/PACKET), CREAM;VAGINAL - 0.01%

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR
INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR
SYSTEM;TRANSDERMAL - 0.025MG/24HR
SYSTEM;TRANSDERMAL - 0.0375MG/24HR
SYSTEM;TRANSDERMAL - 0.05MG/24HR
SYSTEM;TRANSDERMAL - 0.075MG/24HR
SYSTEM;TRANSDERMAL - 0.1MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1MG;0.5MG
TABLET;VAGINAL - 10MCG
TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - 0.5MG;100MG
CAPSULE;ORAL - 1MG;100MG
GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
TABLET;ORAL - 0.25MG;0.5MG
TABLET;ORAL - 0.5MG;1MG
GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)
SPRAY;TRANSDERMAL - 1.53MG/SPRAY
GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET)
GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET)
GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET)
GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET)
GEL;TRANSDERMAL - 0.1% (1GM/PACKET)
CREAM;VAGINAL - 0.01%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 8 SPI Pharma, 2 Seqens, 10 DKSH, 2 Jai Radhe Sales, 2 Nippon Fine Chemical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 33 BASF, 1 BioSpectra, 1 Clariant, 14 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 20 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 46 Direct Compression, 35 Controlled & Modified Release, 34 Solubilizers, 34 Disintegrants & Superdisintegrants, 32 Thickeners and Stabilizers, 31 Granulation, 31 Topical, 24 Parenteral, 24 Film Formers & Plasticizers, 22 Lubricants & Glidants, 21 Co-Processed Excipients, 17 Taste Masking, 15 Emulsifying Agents, 9 API Stability Enhancers, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

92 Fillers, Diluents & Binders
60 Coating Systems & Additives
46 Direct Compression
35 Controlled & Modified Release
34 Solubilizers
34 Disintegrants & Superdisintegrants
32 Thickeners and Stabilizers
31 Granulation
31 Topical
24 Parenteral
24 Film Formers & Plasticizers
22 Lubricants & Glidants
21 Co-Processed Excipients
17 Taste Masking
15 Emulsifying Agents
9 API Stability Enhancers
9 Empty Capsules
8 Chewable & Orodispersible Aids
7 Surfactant & Foaming Agents
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 126 Finished Drug Prices, 7 Annual Reports

1 US Medicaid Prescriptions
126 Finished Drug Prices
7 Annual Reports

MARKET PLACE

10 APIs, 3 FDF Dossiers

10 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

131 US Patents, 6 US Exclusivities

131 US Patents
6 US Exclusivities

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 Others

4 EDQM
3 USP
4 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 3,513 Xls

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11 All

01 1Symbiotec Pharmalab

02 1Aspen API

03 1Fareva

04 13M Drug Delivery Systems

05 1Bayer AG

06 1Catalent Pharma Solutions

07 1Gedeon Richter

08 1Lupin Ltd

09 1Merck & Co

10 1Perlen Packaging

11 1Productos Quimicos Naturales

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11 All

01 1(18F) FES,16 ALPHA-[18F]-FLUORO-17BETAESTRADIOL

02 117 ALPHA-ESTRADIOL

03 1ALPHA-ESTRADIOL

04 2ESTRADIOL

05 1ESTRADIOL HEMIHYDRATE

06 2ESTRADIOL HEMIHYDRATE USP

07 1ESTRADIOL TRANSDERMAL DRUG DELIVERY SYSTEM

08 1ESTRADIOL USP

09 1ESTRADIOL VAGINAL SOFT GELATIN CAPSULES

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11 All

01 1Germany

02 1Hungary

03 2India

04 1Luxembourg

05 1Mexico

06 1Netherlands

07 1Switzerland

08 3U.S.A

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11 All

01 7Active

02 4Inactive

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11 All

01 6Complete

02 5Blank

Symbiotec Estradiol

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

List of Suppliers

Product Main Page

01

Symbiotec Pharmalab Private Ltd

CPhI Worldwide, Milan

Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

Contact Supplier

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Digital Content

Estradiol Hemihydrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2020-04-20

Pay. Date : 2020-03-23

DMF Number : 34147

Submission : 2019-09-11

Status : Active

Type : II

Symbiotec Pharmalab

Product Web Link

Digital Content

Corporate PDF

02

Aspen Oss Bv

CPhI Worldwide, Milan

Aspen API. More than just an API.

Contact Supplier

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2012-12-24

Pay. Date : 2012-11-20

DMF Number : 3829

Submission : 1980-05-21

Status : Active

Type : II

Aspen API Comapny Banner

Product Web Link

Digital Content

03

Valdepharm

CPhI Worldwide, Milan

Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

Contact Supplier

Contact Supplier

Digital Content

Estradiol Hemihydrate

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-27

Pay. Date : 2014-04-24

DMF Number : 22972

Submission : 2009-07-21

Status : Active

Type : II

Fareva Company Banner

Product Web Link

Digital Content

04

Kindeva Drug Delivery Lp

USDMF

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Not Confirmed

04

Kindeva Drug Delivery Lp

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Not Confirmed

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Digital Content

Estradiol Transdermal Drug Delivery System

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 9841

Submission : 1992-08-31

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Bayer Ag

USDMF

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Not Confirmed

05

Bayer Ag

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Digital Content

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-28

Pay. Date : 2013-01-08

DMF Number : 4684

Submission : 1982-10-13

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Catalent Pharma Solutions Llc

USDMF

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Not Confirmed

06

Catalent Pharma Solutions Llc

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Digital Content

Estradiol Vaginal Soft Gelatin Capsules

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 22843

Submission : 2009-06-08

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

07

Gedeon Richter Plc

USDMF

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07

Gedeon Richter Plc

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Digital Content

Estradiol Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-05-24

Pay. Date : 2016-04-26

DMF Number : 4066

Submission : 1981-01-21

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Lupin Ltd

USDMF

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08

Lupin Ltd

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Digital Content

Estradiol Hemihydrate Usp

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-05

Pay. Date : 2013-02-26

DMF Number : 25816

Submission : 2012-04-02

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Organon Inc

USDMF

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Not Confirmed

09

Organon Inc

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Digital Content

Alpha-estradiol

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1388

Submission : 1969-07-14

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Productos Quimicos Naturales Sa De C...

USDMF

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Not Confirmed

10

Productos Quimicos Naturales Sa De C...

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Digital Content

17 Alpha-estradiol

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23856

Submission : 2010-05-27

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

1
2

Estradiol Manufacturers | Traders | Suppliers

Estradiol Manufacturers, Traders, Suppliers 1

81

We have 11 companies offering Estradiol

Get in contact with the supplier of your choice:

Aspen API
Symbiotec Pharmalab
Fareva
3M Drug Delivery Systems
Bayer AG
Catalent Pharma Solutions
Gedeon Richter
Lupin Ltd
Merck & Co
Perlen Packaging
Productos Quimicos Naturales

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