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Biocon Ltd. Regulatory Filings 2020

Jan 20, 2020

61176_rns_2020-01-20_b6c6eac7-de4c-44dc-aeb6-2214ab2b5488.pdf

Regulatory Filings

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Biocon Limited

20th KM Hosur Road Electronics City Bangalore 560 100, India T918028082808 F918028523423 CIN: L24234KA1978PLC003417

January 20, 2020

To www.biocon.comTo
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

Dear Sir/Madam,

Subject: Biocon's Oral Solid Dosage Manufacturing Facility Completes Pre-Approval U.S. FDA inspection with Zero Observations.

Pursuant to Regulation 30 of the SEBI Listing Regulations, please find below the "Company Statement" on the subject matter.

"This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) of the Oral Solid Dosage Manufacturing Facility of Biocon Pharma Ltd, a subsidiary of Biocon Ltd, which was triggered by the submission of an Abbreviated New Drug Application (ANDA).

The inspection of the Bengaluru facility, which took place between January 13 and January 17, 2020, concluded with zero observations and no Form 483 was issued.

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

Meinel.

Mayank Verma Company Secretary & Compliance Officer