Outsourcing
Are CMOs Out of Synch With Market Realities?
By Jim Miller
Why can’t the CMO industry break through to manufacture a greater share of drugs?
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Key Considerations for Quality-Technical Agreements
By Siegfried Schmitt
A drug sponsor’s responsibility does not end when a task is outsourced.
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API Synthesis & Manufacturing
HPAPIs: Fast-growing Segment Presents Challenges and Opportunities
By Cynthia Challener, PhD
Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.
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Life Cycle Management Opportunities in Softgel Technologies
On Demand Webcast
Register Free at:  www.pharmtech.com/opportunities
Cocrystals: Industry Takes a Wait-and-See Approach
By Cynthia Challener, PhD
The perceived risks associated with cocrystals may be slowing progress of their industrial application.
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Supply Chain
Defining Quality Metrics to Ease Drug Shortages
By Susan J. Schniepp
Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.
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BPTF Warns FDA on Reduced API Manufacturer Inspections
The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.
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EMA and European Chemicals Agency Strengthen Collaboration
EMA and ECHA sign agreement to share information and work together on risk assessments.
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DCAT Sharp Sourcing Addresses Procurement Topics
DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.
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Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
Wednesday June 11, 2014 at 11:00 AM EDT
Register Free at:  www.pharmtech.com/cycles
Business Development News
FDA Expands CERSI Network
By Melanie Sena
John Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation.
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India Offers Biopharma Opportunities and Challenges
By Jill E. Sackman and Michael Kuchenreuther
An established drug-manufacturing base with quality and safety issues, and patent protection and price capping concerns complicate efforts to do business in India.
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Turkish Pharma Manufacturers Look to New Markets
The CPhI report warns that Turkey's dynamism is being restricted by the current government reimbursement model.
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