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Biocon Fell 2% After Malaysia Unit Gets 6 Notes From USFDA

Biocon shares fell on Monday after the company acknowledged six US FDA observations.

Biocon shares fell 2% to Rs 258.50 at 9:27 am on Monday after the company acknowledged six US Food and Drug Administration (USFDA) observations.

The USFDA led two cGMP inspections at Biocon’s insulins manufacturing unit in Malaysia, surrounding biologics drug substance, drug product components and quality control laboratories, and the delivery devices unit.

These inspections were directed between July 10 and 20. The agency has issued Form 483 with 6 observations for drug substance, drug product units and quality control laboratories and 2 observations for the delivery devices unit.

These observations chiefly relate to enhancing the operational events and consolidation training programmes. The inspections did not identify any data integrity openings or systemic non-compliance.

It added that we will promptly submit a Corrective and Preventive Action (CAPA) plan to the USFDA and are self-assured to speak these observations expeditiously. Biocon Biologics relics are dedicated to global standards of quality and compliance.

The board of directors’ meeting is scheduled on August 10 to approve and take on record the unaudited standalone and combined financial results for June 30, 2023, amongst other routine matters.

Subsidiary Biocon Biologics proclaimed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had delivered an optimistic opinion commending approval of YESAFILI, an aflibercept biosimilar.

The European Commission will consider the CHMP’s optimistic estimation. The European Commission’s choice on the approval is expected by September 2023.

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