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Biocon Ltd. — Regulatory Filings 2020
Apr 1, 2020
61176_rns_2020-04-01_f8d38a88-748e-4be0-85a0-c12e7815ac40.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
April 1, 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’s Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed
Please find below the “Company Statement” on the subject matter.
“This is to inform you that Biocon Sdn Bhd , a subsidiary of Biocon Limited (BSE code: 532523, NSE: BIOCON) has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) of its Insulins manufacturing facility in Malaysia, for Insulin Glargine. The inspection was conducted between Feb 10 and Feb 21, 2020.
The Inspection has been closed with a “VAI” (Voluntary Action Indicated) classification in the EIR, for the three observations issued at the conclusion of the inspection in Feb 2020. This is an endorsement of our commitment to global standards of Quality and Compliance.
The closing of the USFDA Inspection of our Malaysia Facility is an important milestone in our journey of developing Insulin Glargine for patients in the US. Our Insulin Glargine (Semglee®) application filed by our partner Mylan, with the USFDA under the 505(b)(2) NDA pathway, is currently under review.” - 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