Industry Pipeline - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Industry Pipeline
Interphex Showcase 2010.

Pharmaceutical Technology
Volume 34, Issue 4, pp. 128-135



Quality-management system
Spectrum's Quality-Management System has achieved the International Organization for Standardization's (ISO) 9001:2008 standard. Since 1994, compliance with ISO standards and with the US Food and Drug Administration's current good manufacturing practice regulations have formed the foundation of Spectrum's Integrated Quality system, which is designed to help products get to market quickly. Spectrum Chemical, New Brunswick, NJ http://www.spectrumchemical.com/ tel. 800.901.5516



Powder-into-capsule services
Xcelience offers powder-into-capsule services that enable clients to fill small amounts of active pharmaceutical ingredients (APIs) directly into capsules and speed the time to first-in-human studies. The company's three dedicated systems provide flexibility, expertise, and high capacity. Xcelience has processed more than 30 APIs and 100 batches. Xcelience, Tampa, FL http://www.xcelience.com/ tel. 206.525.5852



Contract analytical services
Impact Analytical provides experienced scientists and state-of-the-art laboratories to provide pharmaceutical drug-development support and analytical services, including release testing, research support, methods validation and development, stability studies, actives quantitation, and raw-material testing. The company is certified by the International Organization for Standardization. Impact Analytical, Midland, MI http://www.impactanalytical.com/ tel. 989.832.5555



Contract manufacturing
Therapex is a contract manufacturer for oral liquid and topical healthcare products. The company offers turnkey services such as product development, technology transfer, and commercial manufacturing and packaging. In-house services include validation, quality control testing, method development, and stability testing. Therapex has more than 300 employees at its FDA-certified plant. Therapex, Anjou, Canada http://www.therapex.com/ tel. 800.465.5820



Development services
Vetter Development Service (VDS) supports drug-development projects from inception to market launch and beyond. The company offers clinical manufacturing from preclinical development through Phase II, with scale-up and transfer to its commercial manufacturing facilities. VDS fills clinical-trial materials under strict aseptic standards and according to good manufacturing practice. Vetter Pharma International, Ravensburg, Germany http://www.vetter-pharma.com/ tel. +49 751 3700 0


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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
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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
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: Pharmaceutical Technology,
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