The aforementioned action from the American drug regulator relates to the cGMP inspection conducted by the agency between 15th and 27th of September 2024.

The inspection scope had included several biologics manufacturing units comprising one drug substance and one drug product manufacturing units, one medical device assembly unit, one analytical quality control laboratory, two microbiological control laboratories and two warehouses.

Biocon Biologics (BBL) is a fully integrated global biosimilars company and the subsidiary of Biocon.

Biocon is an innovation-led global biopharmaceuticals company engaged in the production of therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small-molecule APIs in India and several key global markets, as well as generic formulations in the US, Europe, & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.