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Biocon Ltd. Regulatory Filings 2020

May 8, 2020

61176_rns_2020-05-08_6beb85d0-4f70-4e54-b819-ab9d5cbc5f14.pdf

Regulatory Filings

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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

May 8, 2020

ToThe ManagerBSE LimitedDepartment of Corporate ServicesPhiroze Jeejeebhoy Towers,Dalal Street,Mumbai – 400 001 ToThe Manager,National Stock Exchange of India LimitedCorporate Communication DepartmentExchange Plaza, Bandra Kurla ComplexMumbai – 400 050
Scrip Code- 532523 Scrip Symbol- Biocon

Dear Sir/Madam,

Subject: Biocon's Receives EIR for Small Molecules API Manufacturing Facility for Pre -Approval and GMP U.S. FDA Inspection

Please find below the “Company Statement” on the subject matter.

“This is to inform you that Biocon has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Pre-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, conducted between January 20 and January 24, 2020. At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the Company. The EIR has been closed with a “VAI” classification for the observations.

We remain committed to global standards of Quality and Compliance." - Company Spokesperson

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