The US Food & Drug Administration said on Monday it has completed pre-approval inspection of Biocon’s new oral solid dosage facility in Bengaluru.
The drug regulator audited the plant from November 5 to November 9, 2018.
“The audit concluded without any observations and Form 483 was issued.” Biocon said in a statement to the stock exchanges. “The successful audit of this site reflects our strong commitment to quality and cGMP compliance,” it added.
The USFDA inspection was triggered after Biocon filed for an abbreviated new drug application (ANDA) or product approval in the US. The company didn’t disclose details of the product.
Biocon largely focuses on cholesterol lowering statins, immunosuppressants and cancer drugs as part of its oral solid formulation business.