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Biocon shares drop 2% after USFDA issues 4 observations for Bengaluru API facilityBiocon shares fell 2% to Rs 361.5 after the USFDA issued four observations following an inspection of its Bengaluru API facility. The compa...30 Sep, 2024, 11.23 AM IST- Biocon Biologics' Malaysia insulin facility classified by US FDA for official actionBiocon Biologics has announced that its insulin manufacturing facility in Johor, Malaysia has been classified as an official action indicat...18 Oct, 2023, 12.36 PM IST
- Biocon Biologics gets eight observations from USFDA for Malaysia insulin facilityThe US drug regulator issued 6 observations for drug substance, drug product units and quality Control laboratories and 2 observations for ...21 Jul, 2023, 10.40 PM IST
- USFDA issues CRL for Bevacizumab license application moved by Viatris: Biocon"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company sp...12 Feb, 2023, 08.01 PM IST
- USFDA issues CRL for proposed biosimilar Insulin-R: BioconThe CRL cites additional data required in the BLA submission and an expectation of satisfactory implementation of a corrective and preventi...07 Jan, 2023, 03.38 PM IST
- Biocon drops 4% as USFDA issues form 483 for 3 sitesAs per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when an in...01 Sep, 2022, 12.31 PM IST
- Biocon Biologics receives observations from USFDA: BioconThe USFDA conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru, India an...31 Aug, 2022, 10.01 PM IST
- USFDA issues six observations after inspection of Biocon's Malaysian arm manufacturing facilityA Biocon spokesperson said the company is confident of addressing these observations through procedural enhancements and an appropriate Cor...25 Sep, 2021, 01.36 PM IST
- Biocon says probe on Malaysia manufacturing unit ends“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of ...01 Apr, 2020, 10.12 AM IST
- Biocon shares fall as USFDA issues Form 483 for Bengaluru facilityBiocon said that the observations are procedural in nature.27 Feb, 2020, 11.23 AM IST
- Biocon gets 3 USFDA observations for insulin facility in MalaysiaUSFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargi...22 Feb, 2020, 02.56 PM IST
- USFDA issues response letter for new drug application for insulin glargine: BioconBiocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added.31 Aug, 2019, 04.09 PM IST
- USFDA issues 12 observations for 3 Biocon units in MalaysiaUS health regulator has issued 12 observations after the inspection of three of Biocon's units in Malaysia.08 Jul, 2019, 04.06 PM IST
- USFDA completes Biocon's Telangana plant inspectionThe inspection was concluded without any observations and no Form 483 was issued, the company said.17 Dec, 2018, 12.31 PM IST
- Biocon gets 6 observations from USFDA for Malaysia facilityAs per the US health regulator, observations are made in Form 483 when investigators feel that conditions or practices in the facility are ...21 Feb, 2018, 11.38 AM IST
- Biocon tumbles 9% as USFDA issues 10 observationsThe FDA inspection took place on May 25, June 1 and June 3.04 Aug, 2017, 03.52 PM IST
- Received observations from USFDA, responded to all: BioconThe company was responding to reports that the US health regulator has issued observations under Form 483 highlighting issues related to qu...10 May, 2017, 02.02 PM IST
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