Biocon on Saturday said it has underwent US FDA audit of its Bengaluru API drug substance manufacturing facility in Bengaluru without any observations.
The current good manufacturing practices (cGMP) inspection took place from September 17 to 21. The facility makes active ingredients for both formulations and biologic drugs.
The weeklong audit concluded without any observations and no Form 483 was issued.
"The successful audit of this site reflects our strong commitment to
cGMP compliance," Biocon said in a statement.
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