Pharmaceutical Technology-08-01-2013

Pharmaceutical Technology
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August 01, 2013

Recent draft guidance from FDA on contract manufacturing and quality agreements highlights the importance of such agreements and define the roles and responsibilities of each party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.

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Pharmaceutical Technology

August 01, 2013

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.

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.

Pharmaceutical Technology

Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.

Pharmaceutical Technology

The investment activity of CDMOs and CMOs reveals the broader business and technical trends of the pharmaceutical industry.

Pharmaceutical Technology
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August 01, 2013

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.

Pharmaceutical Technology
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August 01, 2013

The PharmTech/PharmSource annual outsourcing survey results suggest that CDMOs may be getting complacent.

Pharmaceutical Technology
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August 01, 2013

Increased pharmaceutical trade creates new challenges for regulatory oversight.