Top Stories
Citing compliance issues, FDA extends deadline for product tracing information requirements for dispensers to March 1, 2016.
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GEA has entered into a collaboration with GSK to further develop self-contained, POD-based mini-factories for the manufacture of pharmaceutical oral solid dosage forms.
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Industry News
Representatives of the excipients industry responded to FDA’s request with new ways to make the IID more relevant and useful.
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The IQ Consortium is an organization that brings together pharma and biotech companies and facilitates partnerships between members.
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Supplier News
Catalent Pharma Solutions announced plans to quadruple the cold-chain capacity at its existing clinical supply storage and distribution facility in Shanghai, China.
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The new Syrina 2.25 is a compact auto-injector that uses the standard 2.25 mL prefilled syringe, based on Bespak’s proprietary VapourSoft technology.
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The NP-400 is an economical, heavy-duty, medium output rotary tablet press designed, engineered and manufactured in the United States. Capable of running 24/7, the NP-400 can produce up to 180,000 tablets per hour. This single footprint press continuously monitors tablet pre-compression, main compression forces and tablet ejection force. Tablet take off force, press temperature and humidity monitoring are also available. Automatic lubrication systems are standard.
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Bio/Pharma News
ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.
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The company is voluntarily recalling the epinephrine injection, USP because of potential inaccurate dosage delivery.
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Regulatory News
The scheme aims to ensure that EMA and licensing authorities of EU member states will use the same IT system, based on a single data standard.
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The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.
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FEATURED TOPICS |
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INGREDIENTS
Safer solid reagents and new coupling chemistry are important developments.
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REGULATIONS
Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.
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TROUBLESHOOTING
Multi-faceted powder characterization can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.
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OUTSOURCING
Despite emergence of biologics, small-molecule APIs benefit from industry growth.
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Webcasts
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Join this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
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December 08–10, 2015 | Philadelphia, PA
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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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