Top Stories
Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.
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Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
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Industry News
Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.
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Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.
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Supplier News
Elizabeth Scheu & Kniss will supply replacement parts for Bosch capsule-filling machines.
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Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA.
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Bio/Pharma News
Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.
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Biopharmaceutical company, BeiGene, plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.
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Regulatory News
Manufacturers seek gradual rollout of more targeted FDA quality metrics program.
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The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.
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FEATURED TOPICS
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SUPPLY CHAIN
Choosing the correct shipping solutions, including packaging, transportation mode, and monitoring, helps mitigate the risks inherent in global logistics.
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FORMULATION
Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.
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INGREDIENTS
Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.
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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.
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VIEWPOINTS
Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?
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Webcasts
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Learn about the application of various microbial identification methods, strain-typing techniques, microbial classifications, and the benefits of a comprehensive reference database. Attend this in depth presentation by Chris Gilmer, Sr. Microbiologist with Eurofins Lancaster Laboratories and Arnaud Carlotti, President, Eurofins IDmyk.
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Solubility Enhancement
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On Demand
Hear how CoreRx has successfully implemented a flexible automated powder dosing solution for capsule filling, in order to save time, increase accuracy and protect the safety of the scientists working with active pharmaceutical ingredients.
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on pharmtech tv
The Transition from Paper Records to Electronic Batch Records
Pharma & Biopharma Outsourcing Association
Trends and Concerns in Capsule Production
FDA Applications and New Guidance Documents
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Events
September 7–9, 2015 | Seoul, Korea
September 28–30, 2015 | Washington, DC, USA
September 28-30, 2015 | Las Vegas, NV, USA
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REFERENCE BOOKS
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This three-volume set of comprehensive pharmacology reference guides cover solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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