MHRA issues recall of paracetamol tablets
18 June 2019 | By Victoria Rees (European Pharmaceutical Review)
A drug alert has been issued for two batches of paracetamol tablets found to have discolourations due to fungi.
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Drug Safety
India to introduce mandatory barcoding of APIs
17 June 2019 | By Victoria Rees (European Pharmaceutical Review)
A report showing high percentages of counterfeit drugs in India has prompted the country to introduce compulsory barcoding for APIs.
More countries added to the EU-US mutual recognition agreement
13 June 2019 | By European Pharmaceutical Review
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
Three more US states announce lawsuits against Purdue
10 June 2019 | By European Pharmaceutical Review
A total of 48 US states are now suing Purdue Pharma, claiming they falsely marketed their opioid drug.
New partnership established to track drugs using blockchain
4 June 2019 | By European Pharmaceutical Review
Walmart has joined a consortium that’s attempting to build a blockchain for tracking pharmaceutical supply chains.
FDA sends warning letter to Canadian OTC manufacturer
27 May 2019 | By European Pharmaceutical Review
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
GSK and Novartis ‘misled’ consumers, says Federal Court of Australia
20 May 2019 | By Victoria Rees (European Pharmaceutical Review)
GSK and Novartis found to have misled consumers with the packaging and pricing of their osteoarthritis pain treatment.
Nelson Labs: supporting internal quality processes
14 May 2019 | By Nelson Labs
Nelson Labs has a long history of partnering with pharmaceutical and biopharmaceutical companies. We perform a variety of testing to support your internal quality processes including: sterility (USP 71) testing in a cleanroom for isolator environment, particulates testing (USP 787, 788) using a variety of methods, bacterial endotoxin, filter validations,…
Eurofins BioPharma Product Testing
10 May 2019 | By Eurofins
From starting materials through to finished product testing, Eurofins BioPharma Product Testing’s 34 facilities in 17 countries deliver a comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance.
Charles River microbial solutions
8 May 2019 | By Charles River
Those who work in QC know that the job is more than a box to be checked, and that it can’t be done effectively without confidence in the reported results. Tight timelines, regulatory demands, and stringent data integrity standards can make it hard to focus on what’s really at stake…
Whitepaper: Use of exaggerated surface area to solution volume ratios in extractable studies – equilibrium case
8 May 2019 | By Nelson Labs
This whitepaper serves to illustrate the reasons for exaggerating the extracted surface area to extraction solution volume ratios as is the practice in extractables studies.
Long-lasting opioid treatment recommended by an EMA committee
2 May 2019 | By European Pharmaceutical Review
Marketing authorisation has been recommended in the EU by an EMA committee for Sixmo (buprenorphine) as a substitution treatment for opioid dependence.
Guide To Testing
26 April 2019 | By European Pharmaceutical Review
In this edition of our ‘Guide to’ series, learn how these leading companies’ services and expertise can help you test your pharma/ biopharma products and medical devices.
Formulation In-Depth Focus 2019
26 April 2019 | By European Pharmaceutical Review
As today’s scientists continue to identify new biopharmaceutical products with potential to treat a wide array of diseases, formulation remains the determining factor in their success. But what is involved in these increasingly complex formulation processes and how do they impact the packaging and delivery systems?
European Pharmaceutical Review Issue 2 2019
25 April 2019 | By European Pharmaceutical Review
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
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