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BENGALURU FACILITIES USFDA
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- Biocon gets establishment inspection report from USFDA for Bengaluru plantThe EIR has been closed with a voluntary action indicated (VAI) classification for the observations, it added. As per the USFDA, a VAI mean...08 May, 2020, 01.47 PM IST
- Strides receives USFDA approval for Flucytosine CapsulesThe product is a generic version of Ancobon Capsules, 250 mg and 500 mg, of Bausch Health US, LLC, the Bengaluru- headquartered pharmaceuti...20 Apr, 2020, 11.50 AM IST
- USFDA clears four Indian manufacturing plants in 10 daysIndia’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (...14 Apr, 2020, 07.10 AM 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 gets EIR from USFDA for manufacturing facility in BengaluruBiocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good man...20 Mar, 2020, 12.06 PM 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
- USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facilityAs per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditi...27 Jan, 2020, 11.23 AM IST
- USFDA in active mode, issues obersvations to 4 drug makers in 3 days!SMS Pharma today informed exchanges that the United States Food and Drug Administration (USFDA) conducted a cGMP inspection at Kandivalasa,...20 Jan, 2020, 02.18 PM IST
- Cipla announces closure of USFDA inspection at Bengaluru facilityThe company had earlier said that USFDA issued seven observations after conducting a routine 'CGMP inspection' at Cipla's API manufacturing...22 Sep, 2019, 05.20 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 completes inspection of Strides Pharma Bengaluru plantThe company's facility in Bengaluru underwent a United States Food and Drug Administration (USFDA) inspection that ended on May 24, 2019, S...20 Jul, 2019, 05.44 PM IST
- USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violationsAlthough the company committed to addressing issues identified with the water systems and cleaning validation, the overall response lacked ...15 Feb, 2017, 08.31 PM IST
- Strides Shasun receives EIR report from USFDAStrides's KRS Gardens facility manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine).07 Jun, 2016, 11.35 AM IST
- Mylan gets warning letter from USFDA for lapses at 3 unitsUSFDA has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice norms at its three plants in K...19 Aug, 2015, 09.09 PM IST
- USFDA imposes import alert on some Himalaya Drug Company productsThe alert termed "Detention Without Physical Examination of Unapproved New Drugs Promoted in the US" empowers the US Government officials t...02 Aug, 2015, 02.20 PM IST
- USFDA continues nod for Strides Bengaluru oral dosage facilityThe inspection was carried out in August 2014, it added. "The oral dosage facility in Bangalore manufactures oral dosage forms such as tabl...30 Jan, 2015, 05.16 PM IST
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