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Biocon Ltd. Regulatory Filings 2018

Nov 12, 2018

61176_rns_2018-11-12_013b75e7-f047-4045-8063-af2de39b48ba.pdf

Regulatory Filings

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Biocon limited

20th KM Hosur Road Electronics City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN : L24234KA 1978PLC003417

www.biocon.com

Date of submission: November 12, 2018

To To
The Secretary The Secretary
BSE Limited National Stock Exchange of India Limited
Department of Corporate Services Exchange Plaza, ~andra Kurla Complex
Phiroze Jeejeebhoy Towers, Mumbai-400 050
Dalal Street, Mumbai-400 001 Scrip Code- BIOCON
Scrip Code - 532523

Dear Sir/Madam,

  • Sub: Biocon's Generic Formulations Facility in Bengaluru completes U.S. FDA Inspection with No 483 observations
  • Ref: Regulations 30 of SEBI Listing Obligations and Disclosure Requirements {LODR) Regulations, 2015.

Pursuant to Regulation 30 of the SEBI LODR Regulations, 2015, please find below the "Company Statement" on the subject matter.

"This is to inform you that the U.S. FDA conducted a pre approval inspection of our new Oral Solid Dosage Forms manufacturing facility at Biocon Park/ Bengaluru/ from Nov 05- Nov 09/ 2018. The audit concluded without any observations and no Form 483 was issued. The successful audit of this site reflects our strong commitment to quality and cGMP compliance. N -Company Spokesperson.

We request you to kindly take this to your records as per the requirement of LODR and oblige.

Thanking You, Yours faithfully For Biocon Limited

&ik-~ K~vt ~£

Satish Kumar S S Company Secretary