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Irbesartan and hydrochlorothiazide combination tablets -Recall

Another voluntary recall of medications used in the treatment of high blood pressure has been issued due to the detection in the active pharmaceutical ingredient of an impurity considered probably carcinogenic to humans by the U.S. Environmental Protection Agency. To...

Outsourcing facilities must be GMP compliant, though…..

Policies for Outsourcing Facilities Posted 10 December 2018 | By Ana Mulero  The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance...