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The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
CPhI Worldwide will return for its 30th year on 5-7 November 2019 at Messe Frankfurt in Frankfurt, Germany.
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.
The Chinese government has announced that medicines containing ingredients from threatened species such as pangolins will no longer be eligible for insurance coverage.
This August saw nine new green lights from the FDA, all small molecules, which makes up a third of the approvals this year.
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
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.
Two lots of Kogenate® FS vials actually contain the FVIII hemophilia A treatment, Jivi®.