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What Sponsors Should Know About DMF Filings
Tags:
Blog
|
DMFs
|
FDA
|
GDUFA
Posted June 8, 2020
Avoiding FDA Drug Rescissions: Sponsors Seek CDMOs With Strong Regulatory Track Records
Tags:
API Manufacturing
|
Blog
|
FDA
|
GDUFA
Posted February 24, 2020
BPTF Testifies Before House Committee on Energy & Commerce About the Pharmaceutical Supply Chain
Tags:
Congress
|
FDA
|
GDUFA
|
Generic Drug Manufacturing
|
Press Releases
Posted October 30, 2019
Generic API Margins Being Squeezed?
Tags:
API Manufacturing
|
CDMO
|
China
|
GDUFA
|
Generic Drug Manufacturing
Posted January 14, 2019
PCI Synthesis Identifies Trends Affecting the Generic Drugs Sector in 2019
Tags:
API Manufacturing
|
CDMO
|
cGMP
|
FDA
|
GDUFA
|
Press Releases
Posted December 11, 2018
Why Drug Master Files Are An Important Part of API Manufacturing
Tags:
API Manufacturing
|
Blog
|
DMFs
|
GDUFA
Posted September 21, 2018
Despite all the Rhetoric, Time-Consuming FDA Guidelines Make More Work for CMOs but Safe Products for Consumers
Tags:
Blog
|
FDA
|
GDUFA
|
How to select a CMO
|
ICH
|
Pharmaceutical Manufacturing
|
Safety
Posted June 15, 2017
In Pharmaceutical Outsourcing: PCI Synthesis’ top trends for 2016. Did they pan out?
Tags:
Articles
|
GDUFA
|
Pharmaceutical Outsourcing
Posted February 15, 2016
PCI Synthesis Predicts Key Trends Affecting The Generic Drugs Sector in 2016
Tags:
GDUFA
|
Press Releases
Posted December 14, 2015
Grading GDUFA
Tags:
Articles
|
Contract Pharam
|
GDUFA
Posted November 15, 2015
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