AI assistant
Biocon Ltd. — Regulatory Filings 2020
Apr 16, 2020
61176_rns_2020-04-16_170437cd-3332-404d-a583-030bf0443638.pdf
Regulatory Filings
Open in viewerOpens in your device viewer
==> picture [132 x 52] intentionally omitted <==
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 16, 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 |
Subject: Company Statement - Biocon Biologics Receives EIR from U.S. FDA for Two Manufacturing Facilities, Inspection Stands Closed.
Dear Sir/Madam,
Please find below the “Company Statement” on the subject matter.
“This is to inform you that Biocon Biologics India Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. The inspection was conducted between September 10 and September 19, 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.
Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the U.S. FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. This is an endorsement of our commitment to global standards of Quality and Compliance.
The formal closure of the U.S. FDA inspection is expected to enable filing of marketing authorization applications for our biosimilar products in several global markets. We stay committed to enable affordable access to our high quality biosimilars for millions of patients across the globe.” - Company Spokesperson.
Kindly take the same on record and acknowledge.
Thanking You,
Yours faithfully,
For Biocon Limited
==> picture [77 x 81] intentionally omitted <==
==> picture [97 x 37] intentionally omitted <==
Mayank Verma
Company Secretary and Compliance Officer