Ethinylestradiol | API DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Ethinylestradiol
USDMF

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Ethinylestradiol

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 13 USDMF, 10 CEP/COS, 4 JDMF, 2 EU WC, 13 NDC API, 19 Listed Suppliers, $ API Reference Price

35 API Suppliers
13 USDMF
10 CEP/COS
4 JDMF
2 EU WC
13 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

712 FDF Dossiers, 418 FDA Orange Book, 108 Europe, 88 Canada, 56 South Africa, 42 Listed Dossiers

712 FDF Dossiers
418 FDA Orange Book
108 Europe
88 Canada
56 South Africa
42 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, TABLET;ORAL - 0.02MG;0.1MG, RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR, TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 3MG;0.02MG, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

TABLET;ORAL-28 - 0.02MG;1MG
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.03MG;1.5MG
TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
CAPSULE;ORAL - 0.02MG;1MG
TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
TABLET;ORAL - 0.02MG;0.1MG
RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR
TABLET;ORAL - 0.0025MG;0.5MG
TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR
TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 3MG;0.02MG
TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A
TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 8 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, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 36 Direct Compression, 34 Disintegrants & Superdisintegrants, 32 Controlled & Modified Release, 26 Granulation, 25 Thickeners and Stabilizers, 21 Lubricants & Glidants, 18 Co-Processed Excipients, 17 Solubilizers, 16 Taste Masking, 12 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

79 Fillers, Diluents & Binders
55 Coating Systems & Additives
36 Direct Compression
34 Disintegrants & Superdisintegrants
32 Controlled & Modified Release
26 Granulation
25 Thickeners and Stabilizers
21 Lubricants & Glidants
18 Co-Processed Excipients
17 Solubilizers
16 Taste Masking
12 Topical
10 Parenteral
10 Film Formers & Plasticizers
7 Chewable & Orodispersible Aids
7 API Stability Enhancers
6 Emulsifying Agents
5 Empty Capsules
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
3 Surfactant & Foaming Agents

DIGITAL CONTENT

7 DATA COMPILATION #PharmaFlow, 150 NEWS #PharmaBuzz

7 DATA COMPILATION #PharmaFlow
150 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

31 US Medicaid Prescriptions, 102 Finished Drug Prices, 22 Annual Reports

31 US Medicaid Prescriptions
102 Finished Drug Prices
22 Annual Reports

MARKET PLACE

17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

17 APIs
3 FDF Dossiers
1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

30 US Patents, 1 US Exclusivities, 5 Health Canada Patents

30 US Patents
1 US Exclusivities
5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 3 JP, 3 Others

3 EDQM
3 USP
3 JP
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 38,699 Xls

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13 All

01 1Symbiotec Pharmalab

02 1Sanofi

03 1Aspen API

04 13M Drug Delivery Systems

05 1Bayer AG

06 1Cygnus Inc

07 3Gedeon Richter

08 1Industriale Chimica

09 1Lupin Ltd

10 1Merck & Co

11 1Pfizer Inc

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13 All

01 1DROSPIRENONE/ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM

02 4ETHINYL ESTRADIOL

03 1ETHINYL ESTRADIOL TRANSDERMAL DELIVERY SYSTEM

04 2ETHINYL ESTRADIOL USP

05 1ETHINYL ESTRADIOL, USP (MICRONIZED)

06 1ETHINYLESTRADIOL

07 1ETHINYLESTRADIOL USP

08 1NORETHINDRONE 0.5 MG. AND ETHINYL ESTRADIOL 0.035

09 1NORETHINDRONE 1 MG. AND ETHINYL ESTRADIOL 0.035 MG. USP TABS.

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13 All

01 1France

02 1Germany

03 3Hungary

04 2India

05 1Italy

06 1Netherlands

07 4U.S.A

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13 All

01 6Active

02 7Inactive

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13 All

01 5Complete

02 8Blank

Symbiotec Ethinyl Estradiol

List of Suppliers

Product Main Page

01

Symbiotec Pharmalab Private Ltd

CPhI India 2024

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

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Digital Content

Ethinyl Estradiol, Usp (micronized)

GDUFA

DMF Review : Complete

Rev. Date : 2020-04-20

Pay. Date : 2020-03-24

DMF Number : 26020

Submission : 2012-05-02

Status : Active

Type : II

Symbiotec Pharmalab

Product Web Link

Digital Content

Corporate PDF

02

Roussell Uclaf

euroPLX 86 Munich

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Digital Content

Ethinyl Estradiol

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 2425

Submission : 1975-03-27

Status : Inactive

Type : II

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

03

Aspen Oss Bv

CPhI India 2024

Aspen API. More than just an API.

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Digital Content

Ethinyl Estradiol

GDUFA

DMF Review : Complete

Rev. Date : 2012-11-04

Pay. Date : 2012-11-14

DMF Number : 3803

Submission : 1980-05-20

Status : Active

Type : II

Aspen API Comapny Banner

Product Web Link

Digital Content

04

Bayer Ag

USDMF

euroPLX 86 Munich

Not Confirmed

04

Bayer Ag

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinylestradiol

GDUFA

DMF Review : Complete

Rev. Date : 2013-07-11

Pay. Date : 2013-07-05

DMF Number : 1985

Submission : 1972-08-16

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Chemical Works Of Gedeon Richter Plc...

USDMF

euroPLX 86 Munich

Not Confirmed

05

Chemical Works Of Gedeon Richter Plc...

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinyl Estradiol Usp

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 5740

Submission : 1985-02-27

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Gedeon Richter Ltd

USDMF

euroPLX 86 Munich

Not Confirmed

06

Gedeon Richter Ltd

euroPLX 86 Munich

Not Confirmed

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Norethindrone 1 Mg. And Ethinyl Estradiol 0.03...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 6660

Submission : 1986-10-02

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Industriale Chimica Srl

USDMF

euroPLX 86 Munich

Not Confirmed

07

Industriale Chimica Srl

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinylestradiol Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-01-08

Pay. Date : 2012-12-14

DMF Number : 20297

Submission : 2007-02-23

Status : Active

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Lupin Ltd

USDMF

euroPLX 86 Munich

Not Confirmed

08

Lupin Ltd

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinyl Estradiol Usp

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-01

Pay. Date : 2013-04-17

DMF Number : 22506

Submission : 2009-03-13

Status : Active

Type : II

Product Web Link

Digital Content

Corporate PDF

09

Organon Inc

USDMF

euroPLX 86 Munich

Not Confirmed

09

Organon Inc

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinyl Estradiol

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1431

Submission : 1969-09-16

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Pharmacia And Upjohn

USDMF

euroPLX 86 Munich

Not Confirmed

10

Pharmacia And Upjohn

euroPLX 86 Munich

Not Confirmed

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Digital Content

Ethinyl Estradiol

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7224

Submission : 1987-11-09

Status : Inactive

Type : II

Portfolio PDF

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Digital Content

1
2

Ethinylestradiol Manufacturers | Traders | Suppliers

Ethinylestradiol Manufacturers, Traders, Suppliers 1

49

We have 11 companies offering Ethinylestradiol

Get in contact with the supplier of your choice:

Sanofi
Aspen API
Symbiotec Pharmalab
3M Drug Delivery Systems
Bayer AG
Cygnus Inc
Gedeon Richter
Industriale Chimica
Lupin Ltd
Merck & Co
Pfizer Inc

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