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PREVIFEM

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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

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

INTERMEDIATES

4 API Suppliers

4 API Suppliers

FINISHED DOSAGE FORMULATIONS

713 FDF Dossiers, 418 FDA Orange Book, 108 Europe, 88 Canada, 56 South Africa, 43 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- 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE,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- 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL -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

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 2 Seqens, 4 DKSH, 1 Jai Radhe Sales, 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

78 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 Film Formers & Plasticizers, 10 Parenteral, 7 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 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

GLOBAL SALES INFORMATION

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

MARKET PLACE

17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

30 US Patents, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 3 JP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Symbiotec Pharmalab	India	SYMBIOTEC PHARMALAB PRIVATE LTD	26020	ETHINYL ESTRADIOL, USP (MICRONIZED)	2012-05-02	Active	II	Complete	2020-04-20	2020-03-24
26/09/2024	Sanofi	France	ROUSSELL UCLAF	2425	ETHINYL ESTRADIOL	1975-03-27	Inactive	II	N/A

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

PREVIFEM

PREVIFEM

ACCESS ALL DATA

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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

DEVELOPMENTS

23 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

INTERMEDIATES

4 API Suppliers

FINISHED DOSAGE FORMULATIONS

713 FDF Dossiers

418 FDA Orange Book

108 Europe

88 Canada

56 South Africa

43 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

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

5 SPI Pharma

2 Seqens

4 DKSH

1 Jai Radhe Sales

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

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 - 0.02MG;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,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 - 0.005MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

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 - 0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons