EC makes Switzerland exempt from API ‘written confirmation’ requirement
APIs made in Switzerland won’t need ‘written confirmation’ of quality after the EC deemed the country's manufacturing standards meet its requirements.
APIs made in Switzerland won’t need ‘written confirmation’ of quality after the EC deemed the country's manufacturing standards meet its requirements.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.
Indian Plans to hand quality oversight of APIs shipped to Europe to ‘competent authority’ are still being discussed according to Pharmexcil.
BASF’s ever-expanding nutrition unit says its €644m bid last week bid for Norwegian omega-3 firm, Pronova Biopharma, is as important for its food supplements business as its pharmaceutical operations.