Home » Sunrise Pharmaceutical Warned After Using Excess API Amount
Sunrise Pharmaceutical Warned After Using Excess API Amount
February 3, 2010
Sunrise Pharmaceutical received a warning
letter after manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in its batch records. The Rahway,
N.J., company said it used the excess amounts for some stomach, cough and gout drugs to make up for process loss, but none of those losses were documented,
according to the Jan. 14 warning letter.
A process is not in an adequate state of control when excess API is routinely used, the letter says. Drug GMP Report