Id Counterfeit Pharmaceuticals with Portable Raman
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Sandoz Recalls Injectable Following Contamination at Austrian Plant
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23-May-2013 - Sandoz has recalled two lots of an injectable drug after vials were discovered to contain foreign matter, though is unsure of the cause for now. Related news |
News in brief
Pfizer Takes Issue with European Commission’s Plans to Regulate ATMPs
23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
Possible API Contamination at Chinese CMO Leads to Canadian Recalls
22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
FDA Hits Boehringer-Ingelheim with Warning Letter for Particles, cGMP Violations
22-May-2013 - Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
Impax Hires Specialists to Help Sort Manufacturing Issues
22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats
21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing
21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
US House Bill Aims to Expand Release of Clinical Trials Data
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Regulatory & Safety: Featured news
Gallery
People on the Move: Pharma Jobs
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
Gallery
People on the Move: Pharma Jobs
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Mylan, Sigma-Tau and Immunocore.
