Sep 30, 2023

Manufacturing roundup: Aurisco completes FDA inspection of ingredient production site; NIH picks Exothera to develop nasal Covid vaccine

Au­risco Phar­ma­ceu­ti­cal said Tues­day that the FDA gave it the green light to pro­duce ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) at a man­u­fac­tur­ing site in Yangzhou, Chi­na.

The fa­cil­i­ty now has cGMP sta­tus and will pro­duce sev­er­al gener­ic APIs, in­clud­ing semaglu­tide, No­vo Nordisk’s block­buster type 2 di­a­betes and obe­si­ty drug, ac­cord­ing to a news re­lease.

The FDA con­duct­ed the in­spec­tion be­tween Aug. 7 and 11. No ob­ser­va­tions were found that war­rant­ed an in­spec­tion re­port.

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