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Top Pharmaceutical Technology News Stories of 2018 |
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Bayer completed its acquisition of Monsanto, the largest in Bayer's history.
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Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine (Thyroid Tablets, USP) after FDA issues import alert affecting the active ingredient.
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FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.
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Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.
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FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
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Takeda expands its global and therapy base with announced acquisition of Shire.
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Fresenius Kabi claims that Akorn failed to fulfill several closing conditions.
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The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
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FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.
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The acquisition is expected to strengthen Sanofi's R&D strategy with Ablynx's nanobody technology platform.
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Top Pharmaceutical Technology Feature Stories of 2018 |
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This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
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New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.
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The pharmaceutical industry is adopting Industry 4.0 and emerging technologies to improve product quality and manufacturing efficiency.
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This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.
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The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.
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Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.
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Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.
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Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.
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Taking vendor product data at face value puts pharmaceutical manufacturers and their supply chain partners at risk.
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The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
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