Biocon Biologics arm gets OAI status from USFDA for Malaysia insulin facility
Bengaluru: Biocon Sdn Bhd., a step-down subsidiary of Biocon Biologics Limited has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia.
The FDA has determined the inspection classification as “OAI” (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility.
"We submitted a comprehensive Corrective and Preventive Action (CAPA) plan to the FDA in response to observations from the July inspection and believe we are on track to complete all actions as committed. The Company will continue to engage with the Agency to understand any outstanding concerns and work closely to address them expeditiously," the Company's Spokesperson said in a statement.
"We do not believe that this will have a material impact on the manufacturing and distribution of the Company’s commercial products for the US market. Biocon Biologics remains committed to bringing high-quality and affordable medicines to patients in the United States.” he further added.
Read also: USFDA inspection: Biocon Biologics gets 8 observations for Malaysia insulin facility
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. Biocon Biologics has eight commercialized products in global markets. The company has a portfolio of biosimilar assets, including insulins, monoclonal antibodies and conjugated recombinant proteins in therapeutic areas such as diabetology, oncology, immunology, and ophthalmology. Biocon Biologics has invested over USD 1 billion to date in R&D and global scale manufacturing and has end-to-end capabilities for producing drug substance, drug product and delivery devices across multiple sites in India and Malaysia.
