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EDQM outlines ICH Q3D impurities testing guideline integration plan

The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

ADMA to buy US Biotest plant and fix problems that derailed RI-002

ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

Sun declines to comment on New Jersey plant sale speculation

Sun Pharmaceutical Industries has declined to comment on reports it is to sell its US manufacturing business Ohm Laboratories.

Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

Ocular Therapeutix Inc. has resubmitted its eye pain drug Dextenza to the US FDA claiming it has solved manufacturing problems that saw the agency reject the drug in July.

GCP 'Renovation' paper outlines revisions to ICH E8 and E6

ICH is currently seeking public comment on proposed "modernizations" to the clinical trial design, planning, management, and conduct guidelines ICH E8 and E6.

SUKL finds GDP problems at B.Braun warehouse in Czech Republic

Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of GDP guidelines.

Improving solubility: MilliporeSigma opens dedicated meglumine site

MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.

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