Biocon Ltd. — Regulatory Filings 2023

Jan 7, 2023

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Biocon Limited 20th KM, Hosur Road Electronic City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN : L24234KA1978PLC003417 www.biocon.com

January 7, 2023

To, To, The Manager The Manager BSE Limited National Stock Exchange of India Limited Department of Corporate Services Corporate Communication Department Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex Dalal Street, Mumbai – 400 001 Mumbai – 400 050 Scrip Code - 532523 Scrip Symbol - Biocon

Subject: Company Statement

Dear Sir/Madam,

Please find below a Company Statement.

“The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for the Insulin-R product filed by Biocon Biologics. The CRL cites additional data required in the BLA submission and an expectation of a satisfactory implementation of a CAPA plan pertaining to the Pre-Approval Inspection of our Bangalore facilities in Aug’22. We are in the process of comprehensively addressing the CRL.” – Company Spokesperson, Biocon Biologics.

The above information will also be available on the website of the Company at www.biocon.com.

Kindly take the same on record and acknowledge.

Thanking You,

Yours faithfully,

For Biocon Limited

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Mayank Verma Company Secretary and Compliance Officer Membership No.: ACS 18776