Biocon hit with FDA 483 after inspection of API facility
US Food and Drug Administration (FDA) inspectors visited Biocon’s active pharmaceutical ingredient (API) facility in Bengaluru, India, in the second half of January. Biocon described the assessment of the small molecule facility as a pre-approval and good manufacturing practice (GMP) inspection.
The US FDA inspectors found fault with practices at the facility, leading to a Form 483 that detailed five, as-yet-undisclosed observations. Biocon has responded with a Corrective and Preventive Action Plan.
Form 483s can lead to warning letters with more severe consequences, particularly for the product that was the subject of the pre-approval inspection. However, a spokesperson for Biocon said the company is “confident of addressing these observations expeditiously.”
Biocon is yet to disclose which product was the subject of the pre-approval inspection. Fulphila, the biosimilar copy of filgrastim that is partnered with Mylan, is made at a new Biocon biologics plant in Bengaluru but the US FDA inspection that triggered the Form 483 focused on the small molecule API side of the operation.
In a separate development, the small molecule API side of Biocon’s business was the subject of a recent restructuring that will affect the creation of new facilities. Starting with the new, $100m (€90.9m) immunosuppressant API plant in Vizag, all small molecule facilities set up by Biocon in India will be part of its Biosphere subsidiary.
Biocon created the subsidiary late last year. Siddharth Mittal, CEO and joint managing director of Biocon, explained the reasoning behind the creation of the subsidiary on a recent conference call with investors.
Mittal said, “All our new manufacturing facilities would be under this legal entity for small molecules business, which will also enable us to avail the tax benefit of 15%. The Government of India had announced ... that any new manufacturing entity set up after October '19 will be eligible for a reduced rate of 15%.”
Biocon’s effective tax rate last year was 22%, down one percentage point over the previous period. The use of the reduced rate offered by the Indian government to manufacturers could help Biocon continue to control its tax rate.