Pharmaceutical Technology, Aug 1, 2013 - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Pharmaceutical Technology, Aug 1, 2013
Featured Content
Stability Reigns in Contract Services
By Jim Miller
The PharmTech/PharmSource annual outsourcing survey results suggest that CDMOs may be getting complacent.
A Shifting Landscape for the Global API Market
By Patricia Van Arnum
External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.
Tracking the Expansion Activities of Contract Service Providers
By Patricia Van Arnum
The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.
Evaluating China's Supply Chain
By Patricia Van Arnum
Increased pharmaceutical trade creates new challenges for regulatory oversight.
Optimizing Development, Manufacturing, and Technology Transfer in the Outsourced Relationship
By Marga Viņes
Successful product development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The author, Marga Vines from Grifols International, analyzes a project for an injectable drug for which a new drug application was submitted to FDA.
Implications for APIs in the European Falsified Medicines Directive
By Adeline Siew, PhD
Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.
Defining Quality Agreements
By Patricia Van Arnum
Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party to be in keeping with quality risk-management principles.
Rx-360 Advances Supply-Chain Security
By Adeline Siew, PhD
Rx-360, a pharmaceutical industry supply-chain consortium, is advancing approaches between pharmaceutical companies, suppliers, and contract manufacturers to better secure the pharmaceutical supply chain.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
35%
Breakthrough designations
12%
Protecting the supply chain
35%
Expedited reviews of drug submissions
12%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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