| October 2015, Volume 11 Issue 10
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Supply Chain
FDA selected USDM Life Sciences, RC Partners, and The Clarion Group to develop and implement a DSCSA pilot project.
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Polydrug Laboratories is issued a US import alert, following similar bans in Canada and Europe.
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United Cargo signs global rental agreement with va-Q-tec for controlled transport of pharmaceuticals.
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GS1 standard tracks movement and status of goods, enabling better visibility, security and regulatory compliance.
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ReposiTrak signs agreement to pilot track and trace system in pharma.
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API Synthesis & Manufacturing
The use of low-temperature chemistry can often lead to more direct, cost-effective routes to sophisticated pharmaceutical compounds.
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Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.
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EMD Millipore has introduced expanded documentation and regulatory information for its Emprove portfolio of pharmaceutical raw materials.
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The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.
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Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.
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Regulation & Compliance
Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.
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The agency releases guidance on controlled correspondences related to generic-drug development.
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Outsourcing
The high cost of disposables is a factor in restricting adoption of single-use devices.
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PharmSource forecasts slow growth in a new report on the outlook for the contract manufacturing industry.
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Contract Services
Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.
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The Grünenthal Group’s Tecnandina manufacturing plant in Ecuador has received the country’s first certification from the Regulatory Authority of Brazil.
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Sterigenics International will triple West Memphis sterilization capacity with $15 million expansion.
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Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.
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The CDMO is striving to become a market leader in the development and manufacturing of antibody-drug conjugates.
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Pharma development and manufacturing firm Patheon announces new tagline and logo.
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SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.
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