All News #Library
Quality
Biocon Gets 1 USFDA Observation For Cranbury Site
14 Oct 2025 //
INDPHARMAPOST
USFDA observations for Biocon Biologics unit. Details here
08 Aug 2024 //
CNBCTV18
USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru
29 Jul 2024 //
INDIANPHARMAPOST
Biocon Gets 4 Observations From USFDA For Andhra Pradesh Facility
22 Jun 2024 //
ECONOMICTIMES
USFDA issues CRL for proposed biosimilar Insulin Aspart: Biocon
09 Oct 2023 //
ECONOMICS TIMES
Biocon Biologics gets 8 observations from USFDA for Malaysia insulin facility
21 Jul 2023 //
ECONOMIC TIMES
USFDA issues CRL for Bevacizumab license application moved by Viatris: Biocon
12 Feb 2023 //
ECONOMIC TIMES
USFDA issues a CRL for the Biologics License Application for Insulin-R
09 Jan 2023 //
PRESS RELEASE
U.S. FDA Flags Quality, Procedural Lapses At Biocon Biologics’ Facilities
26 Sep 2022 //
BQPRIME
Viatris` Mylan recalled one lot of non-interchangeable Semglee
21 Jan 2022 //
FIERCEPHARMA
USFDA Rejects Biocon, Viatris Application For Insulin Aspart
10 Jan 2022 //
OUTLOOKINDIA
FDA cites Biocon insulin plant in Malaysia with 6 problems
30 Sep 2021 //
FIERCEPHARMA
Biocon gets EIR from USFDA for manufacturing facility in Bengaluru
23 Mar 2020 //
INDIATIMES
Biocon`s Insulin Manufacturing Facility in Malaysia Completes U.S. FDA (PAI) Inspection
24 Feb 2020 //
PRESS RELEASE
Biocon hit with FDA 483 after inspection of API facility
07 Feb 2020 //
IN-PHARMATECHNOLOGIST
USFDA issues Form 483 with 5 observations to Biocon`s Bengaluru facility
28 Jan 2020 //
ECONOMIC TIMES
FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin
14 Jun 2019 //
RAPS
Biocon biosimilar plant criticized again by the FDA
12 Mar 2019 //
FIERCE PHARMA
Biocon dips 4% on seven USFDA observations for Bengaluru drug facility
02 May 2018 //
BUSINESS-STANDARD
Biocon gets 6 observations from USFDA for Malaysia facility
20 Feb 2018 //
ECONOMIC TIMES
Biocon says Malaysia insulin plant passed HPRA inspection
12 Sep 2017 //
IN PHARMATECHNOLOGIST
Biocon insulin plant in Malaysia wins EU manufacturing approval
11 Sep 2017 //
FIERCE PHARMA
Biocon and Mylan face Herceptin biosimilar stalled in EU
11 Jul 2017 //
FIERCE PHARMA
US FDA sends Biocon Bangalore plant 483 with 8 observations
10 May 2017 //
IN PHARMATECHNOLOGIST
NPPA`s drug overcharging penalty at a record high
11 Mar 2017 //
BUSINESS STANDARD
Top pharma cos overcharging, NPPA lists 634 drugs for breaching price cap
27 Feb 2017 //
BUSINESS STANDARD

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