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AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, and Eli Lilly and Company said they are working to restore normal operations at their respective facilities and continuing recovery efforts.
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The US Department of Justice reports that AmerisourceBergen has pled guilty to illegally distributing misbranded oncology drugs and will pay a $260-million penalty.
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Industry News
The agency published four guidance documents regarding ANDAs and amendments to ANDAs.
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The agency will require training for healthcare providers who prescribe immediate-release opioids.
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Supplier News
Eurofins Scientific has opened a £4-million (US$5-million) pharmaceutical chemistry and microbiology facility in Livingston, Scotland, to support the company's product and water testing businesses in the UK.
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Solid state solutions provider Holodiag and fine chemical R&D provider Holochem join forces.
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Bio/Pharma News
A grant from the Bill & Melinda Gates Foundation will advance PnuVax's pneumonia vaccine's clinical development and biomanufacturing scale-up using a low-cost manufacturing approach.
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Amgen will collaborate with China's Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.
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Regulatory News
The FDA commissioner made a statement about the agency's efforts to ensure patient access to safe compounded medicines.
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FDA sent a warning letter to Shandong Vianor Biotech Co., Ltd. that claimed the company failed to follow proper data integrity and quality control procedures.
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Excipients
Functionalized calcium carbonate provides high porosity, which enables fast disintegration, and excellent compactibility that results in harder tablets at low compression forces.
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Manufacturing
While cold-form, foil-foil (aluminumaluminum) blister packaging is considered the most moisture-protective packaging available, in fact, plastic containers such as bottles and tubes, when combined with desiccants, such as silica gel canisters and packets, will often provide lower internal relative humidity for long time periods.
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Analytics
Informatics software can be used to address the challenges of quality by design, such as managing impurity data when developing an impurity control strategy.
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eBOOKS
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Biologics and Sterile Manufacturing
New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics. |
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