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EDQM: Harmonized generic drug reviews would help regulators, pharmas and patients

Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.


Codexis completes transfer of protein engineering tech to US GSK site

Codexis has completed the transfer of its protein engineering platform to a GSK earning it a $7.5m milestone payment.

French regulators lift manufacturing ban at Catalent softgel plant

Full production at Catalent’s Beinheim softgel plant has begun five months after the discovery of out-of-place capsules led to French regulators suspending operations.

Xellia and US FDA agree to modified consent decree at ex-Ben Venue site

The US FDA has modified a 2013 consent decree issued to Ben Venue Laboratories, paving the way for new owners Xellia Pharmaceuticals to resume manufacturing at the dormant Ohio site.

Cambrex: delayed API plant opening set for Q2 opening

An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.

Uninvestigated complaints of APIs containing 'filth' land Polydrug with FDA warning

Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.

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