The US Food and Drug Administration has issued a Form 483 with five observations for Biocon’s API Manufacturing facility.
Form 483 observations are issued when US FDA inspectors notice shortcomings in a company’s manufacturing processes, data storage and so on during an inspection.
The company has to address the issues raised in the Form 483 within a stipulated time.
In this case, said Biocon, the inspection was conducted as a pre-approval formality. Pre-approval inspections are conducted by the US FDA when a company seeks permission to export medicines or chemicals to the US.
The US FDA will give permission to market the drug only after the company addresses the shortcomings highlighted in the form.
APIs or active pharmaceutical ingredients are the core molecules used in a medicine or drug. Biocon has more than one facility to manufacture APIs, and the company did not clarify which facility was subjected to the inspection last week.
“We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously,” Biocon said in a statement.
Biocon is among the most prestigious pharma companies in India.
It manufactures generic active pharmaceutical ingredients (APIs) that are sold in the developed markets of the United States and Europe.
It also manufactures biosimilar insulins, which are sold in India as branded formulations and in both bulk and formulation forms.
It is one of the few Indian pharma companies that are present in the research space in a strong way.
Located with R&D in Bangalore and API unit in Hyderabad, India, Biocon has two subsidiaries— Syngene and Clinigene.
Biocon’s presence straddles four main therapeutic areas—Diabetology, Cardiology, Nephrology and Oncology.
Syngene International is engaged drug discovery while Clinigene International is in the clinical development space.