Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.
The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.
Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
