The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan. / read more /
FDA sent a warning letter to Goran Pharma Private Limited after an inspection of the company’s Sihor, Gujarat, India facility found deviations from current good manufacturing practices (CGMPs). / read more /
Pfizer announced that it will reorganize into three businesses—a science-based innovative unit, an off-patent branded and generic drug business unit, and a consumer healthcare business—effective at the beginning of the company's 2019 fiscal year. / read more /
Takeda Pharmaceutical Company Limited reached an agreement on the terms of an offer to acquire Shire plc in a deal valued at $62 billion. / read more /
The European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval during its July 2018 meeting. / read more /
The agency revealed it was reviewing products containing valsartan supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China. / read more /
Novartis announced agreement to sell selected portions of its Sandoz United States portfolio to generic pharmaceutical company Aurobindo Pharma USA. / read more /
Sanofi completed its acquisition of Ablynx, a Belgian biopharmaceutical company that develops proprietary therapeutic proteins based on single-domain antibody fragments. / read more /
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. / read more /
New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms. / read more /
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline. / read more /
This article expands, with the authors’ rationale, upon a previously published summary that presented difficulties with the revised European guidelines on sterile manufacturing. / read more /
Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product. / read more /
The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products. / read more /
Date: 6 & 7 February 2019 Venue: Paris Expo, Porte de Versailles – Hall 7.2, Paris, France
As Europe's dedicated Pharmaceutical Packaging and Drug Delivery event, Pharmapack is the industry's go-to place to kick-off the year. Join 411 exhibitors and 5,290 attendees for 2 days of Exhibition floor, Conferences and Innovation browsing and get an update on the latest trends, developments and regulations impacting the industry. / Read more/
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.
