The US Food and Drug Administration (USFDA) has issued a complete response letter to Biocon Ltd seeking additional data in the company’s licence application for the Insulin-R product, the pharma company said in an exchange filing today.
The reply letter included a statement that a corrective and preventive action plan for the pre-approval inspection of Biocon’s facilities in Bengaluru was expected to be satisfactorily implemented.
After evaluating Biocon’s seven manufacturing facilities spread over two sites in Bengaluru and one site in Malaysia, the federal agency issued Form 483 with numerous observations in August.
In these facilities, the company produces biosimilar medications such Bevacizumab, rh-Insulin, and Insulin Aspart.
According to the company’s filing, Biocon is currently working to respond fully to the US Food and Drug Administration’s response letter.