Biocon shares drop 2% after USFDA issues 4 observations for Bengaluru API facility

Biocon shares dropped 2% to Rs 361.5 in Monday's trade on BSE after the company said that the US Food and Drug Administration (USFDA) issued four observations following an inspection of its Bengaluru-based Active Pharmaceutical Ingredient (API) facility.

The USFDA conducted a surveillance inspection of the facility, located at Site 2 in Bengaluru, from September 23 to September 27, 2024, Biocon stated in an exchange filing. "Four observations were cited at the end of the inspection, which the company will address within the stipulated time," the filing added.

Biocon further clarified that it does not anticipate any material impact on its business operations due to these observations.


Shares of Biocon have surged 44% in 2024 to date and 30% over the past two years, with the company currently holding a market capitalization of Rs 44,266 crore.

In a separate development, the USFDA also conducted a current Good Manufacturing Practice (cGMP) inspection of Biocon Biologics' insulin manufacturing facility in Malaysia between September 17 and September 27, 2024. The inspection covered several biologics manufacturing units, including one Drug Substance and one Drug Product unit, a Medical Device Assembly unit, an Analytical Quality Control Laboratory, two Microbiological Control Laboratories, and two Warehouses.

The inspection concluded with the issuance of a Form 483, which outlined: five observations across the Drug Substance and Drug Product facilities; zero observations at the Medical Device Assembly unit; three observations related to the Analytical and Microbiological Quality Control Laboratories; and none for the Warehouse operations.

"Biocon Biologics will submit a comprehensive Corrective and Preventive Action (CAPA) plan to the agency and is confident of addressing these observations expeditiously. The company does not foresee the outcome of these inspections to impact the supply of its commercial products. Biocon Biologics remains committed to global standards of quality & compliance and to serving patients across the world," the company spokesperson said.

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