FDA faults Biocon small molecule API facility during preapproval review

The FDA has found a handful of issues with Biocon’s small molecule API facility in Bengaluru, India. The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week of its small molecule API facility. It didn’t say what product it is hoping to get approved for production at the plant or what the issues are but pledged to get on them. “We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of Quality and Compliance,” Biocon said in a statement. RELATED: Mylan's Lantus copy derailed in U.S. again by manufacturing ills Biocon has had some other issues with manufacturing. Just days earlier, in its quarterly report, Biocon pointed out that in August the FDA had issued an Establishment Inspection Report from the FDA stating the agency had closed its inspection of the Biologics Drug Product facility in Bengaluru. In December, the agency greenlighted the facility to manufacture the drug substance for Fulphila (pegfilgrastim), which it is making for Mylan. The drug, a blood cell booster for cancer patients, is Mylan’s knockoff of Amgen’s Neulasta. EDITOR'S NOTE: The story was updated to indicate that the observations were for Biocon's small molecule API facility and not its biosimilar's plant.

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