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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
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