Biocon gets USFDA and EMA observations at Bangalore facility

As per the company, the observations are not critical but procedural in nature and it will reply to both the agencies within the stipulated time.

May 02, 2018 08:05 IST India Infoline News Service

Biocon Limited
Biocon has said that the USFDA has completed a pre-approval inspection of its sterile drug product manufacturing facility in Bangalore this week and has issued a Form 483 with 7 observations.

As per the press release, the observations are largely procedural in nature and are aimed at continuous improvement of the facility. The company has said that it will respond to the FDA with a corrective and preventive action plan in a timely manner.

Biocon has further said that it has received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bangalore in March 2018. This report lists 6 major observations with no observation classified as critical. The company has said that it will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.

Biocon’s biosimilars Trastuzumag, Pegfilgrastim and Glargine are nearing the approval stage in Europe and the US and these inspections were likely to be triggered due to this. This, however, is a near term setback for the company, as it will need to resolve the issues soon to get the biosimilars approved.


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