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Making Science Work at CPhI Worldwide 2019
CPhI Worldwide now comprises six individual pharma events and more than 20 dedicated zones.
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Ingredients
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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Losartan drug recall expanded to include five more lots
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
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Three decades of pharmaceutical excellence: CPhI Worldwide
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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Allowable levels of excipients in drug products
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
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How tablet formulation can impact production
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
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Drugs with ingredients from threatened species not covered by Chinese insurance
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
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Small molecules dominate FDA drug approvals this month
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
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FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
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17 Spanish infants develop ‘werewolf syndrome’ after drug mislabelling
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
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The Nagoya Protocol: sharing the benefits of pharmaceutical products and protecting biodiversity
Researchers use the Earth’s biodiversity for pharmaceuticals, but this is under threat due to climate change and habitat destruction. The Nagoya Protocol aims to conserve these resources in a sustainable way.
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Two lots of Kogenate® recalled due to mislabelling
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.
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Complete response letter given to ALS treatment for API concern
The FDA has handed a CRL to Biohaven for its ALS treatment awaiting approval due to concerns regarding the medication’s API.
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FDA publishes guidance for Inactive Ingredient Database
The FDA has released draft guidance for using the Inactive Ingredients Database to aid drug developers.
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Article: Inorganic elemental impurity mixes according to ICH Q3D guidelines
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
