Synopsis
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2789
Submission : 1976-11-11
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-04
Pay. Date : 2016-04-08
DMF Number : 30373
Submission : 2016-03-03
Status :
Type : II
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 1413
Submission : 1969-09-02
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-03
DMF Number : 31349
Submission : 2017-01-12
Status :
Type : II
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-09
Pay. Date : 2015-06-09
DMF Number : 29221
Submission : 2015-03-30
Status :
Type : II
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37639
Submission : 2023-01-24
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7416
Submission : 1988-04-04
Status :
Type : II
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API Imports and Exports
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Drugs in Development
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DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%
USFDA APPLICATION NUMBER - 20805
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50168
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 80693
DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 8697
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 8697
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Fillers, Diluents & Binders
Solubilizers
Thickeners and Stabilizers
Parenteral
Direct Compression
Coating Systems & Additives
Disintegrants & Superdisintegrants
Lubricants & Glidants
Granulation
Emulsifying Agents
Controlled & Modified Release
Co-Processed Excipients
Film Formers & Plasticizers
Surfactant & Foaming Agents
Taste Masking
Chewable & Orodispersible Aids
Rheology Modifiers
API Stability Enhancers
Coloring Agents
Soft Gelatin
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
BioAnalytical Methods
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