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Top Stories
The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.
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The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.
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Meet leading maintenance, reliability, engineering and operations professionals from pharma, medical devices and life science industries for high-value networking and expert knowledge exchange at Pharma TechOps USA 2019 on March 7-8, 2019 in San Diego. Discuss best practice strategies for maintenance and reliability in the pharma, the value proposition of such policies, current and future challenges as well as practical solutions. For more information visit
 https://www.pharma-techops-usa.com/ |
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Industry News
CPhI Worldwide organizers have revealed that the 2020 edition of the pharma event will return to the Fiera Milano venue in Milan, Italy.
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The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.
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Exclusive Interview from AAPS
Developing New Technologies in Controlled Release
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Supplier News
G-CON will provide a complete cleanroom infrastructure for GE Healthcare's cell therapy and viral vector production platforms that will simplify early-stage manufacturing efforts.
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Horizon and Rutgers University will partner to develop and commercialize new gene editing technology for therapeutic and research applications.
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Bio/Pharma News
This injection formulation of USP-grade leucovorin calcium is now available in the United States.
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Merck & Co.'s V920 (rVSV-ZEBOV) vaccine is expected to pave the way for the development of vaccines for emerging infectious disease with unpredictable disease incidence or geography, according to data and analytics company, GlobalData.
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Regulatory News
The guidance describes how to develop a REMS Assessment Plan, discusses the impact of REMS on patient access to drugs, and gives recommendations on reporting REMS findings to FDA
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PROCESS VALIDATION
Shortages of life-saving drugs are a regulatory and industry concern. Proper process development may help to ensure drug supply.
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ANALYTICS
Early adoption of the right approach to address solubility can deliver significant benefits.
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PEER-REVIEWED RESEARCH
This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Events
March 3–6, 2019
March 11–13, 2019
March 17–21, 2019
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eBOOKS
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The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation—as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing. |
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