Synopsis
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
NDC
KDMF
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API.
CEP/COS
JDMF
NDC
KDMF
VMF
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
CEP/COS
JDMF
NDC
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
CEP/COS
EU-WC
NDC
KDMF
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Aspen API. More than just an API.
Registration Number : 218MF10586
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2022-04-20
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
Registration Number : 303MF10123
Registrant's Address : Parc Industriel d'Incarville Parc de la Fringale CS 10606 27106 Val de Reuil Cedex Fr...
Initial Date of Registration : 2021-08-02
Latest Date of Registration : 2021-08-02
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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API Imports and Exports
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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
CAS Number : 1944-63-4
End Use API : Estradiol
About The Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and in...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Sweden
Brand Name : Divigel
Dosage Form : GEL IN SINGLE-DOSE CONTAINERS
Dosage Strength : 0.5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Divigel
Dosage Form : GEL IN SINGLE-DOSE CONTAINERS
Dosage Strength : 1 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Sandrena
Dosage Form : Estradiol 1G 28 Units Gel Transdermal Use
Dosage Strength : transd gel 28 single doses 1 g 0,1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Menopause
Dosage Form : Vaginaltablett
Dosage Strength : 10 microg
Packaging : Blisterpakning 24item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.025MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.0375MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.06MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.075MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.1MG/24HR
USFDA APPLICATION NUMBER - 20375
DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - 0...DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - 0.0075MG/24HR
USFDA APPLICATION NUMBER - 20472
DOSAGE - SYSTEM;TRANSDERMAL - 0.025MG/24HR
USFDA APPLICATION NUMBER - 20538
DOSAGE - SYSTEM;TRANSDERMAL - 0.0375MG/24HR
USFDA APPLICATION NUMBER - 20538
DOSAGE - SYSTEM;TRANSDERMAL - 0.05MG/24HR
USFDA APPLICATION NUMBER - 20538
DOSAGE - SYSTEM;TRANSDERMAL - 0.075MG/24HR
USFDA APPLICATION NUMBER - 20538
DOSAGE - SYSTEM;TRANSDERMAL - 0.1MG/24HR
USFDA APPLICATION NUMBER - 20538
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR
USFDA APPLICATION NUMBER - 20870
DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal ...DOSAGE - TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20907
DOSAGE - TABLET;ORAL - 1MG;0.5MG
USFDA APPLICATION NUMBER - 20907
DOSAGE - TABLET;VAGINAL - 10MCG
USFDA APPLICATION NUMBER - 20908
DOSAGE - TABLET;VAGINAL - 25MCG **Federal Reg...DOSAGE - TABLET;VAGINAL - 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20908
DOSAGE - CAPSULE;ORAL - 0.5MG;100MG
USFDA APPLICATION NUMBER - 210132
DOSAGE - CAPSULE;ORAL - 1MG;100MG
USFDA APPLICATION NUMBER - 210132
DOSAGE - GEL, METERED;TRANSDERMAL - 0.06% (1....DOSAGE - GEL, METERED;TRANSDERMAL - 0.06% (1.25GM/ACTIVATION)
USFDA APPLICATION NUMBER - 21166
DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL -...DOSAGE - FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR
USFDA APPLICATION NUMBER - 21258
DOSAGE - TABLET;ORAL - 0.25MG;0.5MG
USFDA APPLICATION NUMBER - 21355
DOSAGE - TABLET;ORAL - 0.5MG;1MG
USFDA APPLICATION NUMBER - 21355
DOSAGE - GEL, METERED;TRANSDERMAL - 0.06% (0....DOSAGE - GEL, METERED;TRANSDERMAL - 0.06% (0.87GM/ACTIVATION)
USFDA APPLICATION NUMBER - 21813
DOSAGE - SPRAY;TRANSDERMAL - 1.53MG/SPRAY
USFDA APPLICATION NUMBER - 22014
DOSAGE - GEL;TRANSDERMAL - 0.1% (0.25GM/PACKE...DOSAGE - GEL;TRANSDERMAL - 0.1% (0.25GM/PACKET)
USFDA APPLICATION NUMBER - 22038
DOSAGE - GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET...DOSAGE - GEL;TRANSDERMAL - 0.1% (0.5GM/PACKET)
USFDA APPLICATION NUMBER - 22038
DOSAGE - GEL;TRANSDERMAL - 0.1% (0.75GM/PACKE...DOSAGE - GEL;TRANSDERMAL - 0.1% (0.75GM/PACKET)
USFDA APPLICATION NUMBER - 22038
DOSAGE - GEL;TRANSDERMAL - 0.1% (1.25GM/PACKE...DOSAGE - GEL;TRANSDERMAL - 0.1% (1.25GM/PACKET)
USFDA APPLICATION NUMBER - 22038
DOSAGE - GEL;TRANSDERMAL - 0.1% (1GM/PACKET)
USFDA APPLICATION NUMBER - 22038
DOSAGE - CREAM;VAGINAL - 0.01%
USFDA APPLICATION NUMBER - 86069
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Parenteral
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