Regarding for fexofenadine at Sriprasit factory.
Sriprasit sent the comment letter to us. ( Please see the attachment file )
They said : our raw material have problem for dissolution item = 2 Batch as below ;
F150040067 & F150040068 , Test result for two batch is not passed ( test result is not follow up USP. )
They want same spec. Batch No. F150040046 ( Please see the attachment file )
Batch No. F150040046 = Test result for dissolution is passed and follow up USP.
They asked for investigate report for two batch (F150040067 & F150040068 )
They want Manufacturing change Solvent of production system or change production system.
They want same spec. Batch No. F150040046 ( Please see the attachment file )
Batch No. F150040046 = Test result for dissolution is passed and follow up USP.