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Top Stories
The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.
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Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.
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Podcast
Jonathan Knight, vice-president of New Product Development at Cambrex Corp., discusses the environmentally friendly, economical process route that won CPhI's 2016 award for innovation in APIs and intermediates.
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The interactive 2017 PDA Quality Risk Management for Manufacturing Systems Workshop, Jun. 19-20, will demonstrate how to transition to risk-based approaches that will help you streamline decision making, optimize resource utilization, increase efficiencies and meet the expectations of global health authorities. Explore the many facets of QRM and receive a FREE copy of PDA's newest technical report on this subject.
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Industry News
The agency released guidance for industry regarding the United Kingdom's withdrawal from the European Union.
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The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.
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Supplier News
The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.
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Expanded storage capacity at the SGS laboratory in Mississauga, Canada increases stability testing capabilities.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Bio/Pharma News
The company voluntarily recalled one lot of Brilinta 90 mg professional samples because it contained another medicine.
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The company will expand its production facilities in Carlow and Cork to meet increased global demand for its medicines and vaccines produced in Ireland.
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Regulatory News
The agency published an action plan to nurture innovation and drug development by SMEs.
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The author discusses upcoming serialization and transaction data collection regulations including the US Drug Supply Chain Security Act, the European Union Falsified Medicines Directive, and the EU Delegated Regulation.
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Gain Insight into Emerging Regulatory Trends with the 2017 PDA/FDA Joint Regulatory Conference
The 2017 PDA/FDA Joint Regulatory Conference is the premier pharmaceutical manufacturing event where you can engage directly with U.S. FDA representatives and industry experts! Over two and a half information-packed days, FDA regulators will provide updates on current efforts affecting the development of global regulatory strategies, and industry experts will illustrate how they use global strategies to improve the quality of medical products.
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MANUFACTURING
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
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QUALITY
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
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SUPPLY CHAIN
The complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.
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PEER REVIEWED RESEARCH
In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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Events
June 12, 2017
June 19–22, 2017
July 13–14, 2017
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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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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