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Biocon Ltd. Regulatory Filings 2020
61176_rns_2020-01-27_1e378436-c5d7-4518-9973-39969d948341.pdf
Regulatory Filings
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Biocon Limited
20th KM Hosur Road Electronics City Bangalore 560 100, India T918028082808 F918028523423 CIN: L24234KA1978PLC003417
January 27, 2020
| www.biocon.com |
|---|
| To |
| The Manager, |
| National Stock Exchange of India Limited |
| Corporate Communication Department |
| Exchange Plaza, Bandra Kurla Complex |
| Mumbai - 400 050 |
| Scrip Symbol- Biocon |
Dear Sir/Madam,
Subject: Biocon's API Manufacturing Facility Completes Pre-Approval and GMP U.S. FDA inspection.
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) and GMP inspection of the API Manufacturing Facility of Biocon Ltd.
At the conclusion of the inspection of the Bengaluru facility, which took place between January 20 and January 24, 2020, the agency issued a Form 483, with five observations.
We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. 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
Welmer.
Mayank Verma Company Secretary & Compliance Officer
