Biocon Ltd. — Regulatory Filings 2020

Mar 20, 2020

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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

March 20, 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: Company Statement - Biocon Receives EIR for Small Molecules API Manufacturing Facility for Post - 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 Post-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020. The EIR has been closed with a “VAI” classification for the observations. At the conclusion of the inspection last month the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the Company.

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