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CGMP COMPLIANCE
USFDA pulls up Cipla for manufacturing lapses at Pithampur plantA warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. "Your firm fa...22 Nov, 2023, 08.30 PM IST- USFDA warns Cipla for lapses in manufacturing practices at Pithampur facilityAccording to an exchange filing, the drug manufacturer was given a detailed breakdown of the lapses in methods followed at the facility by ...20 Nov, 2023, 08.30 AM IST
- USFDA issues warning letter to Intas Pharma for Sanand plantIntas Pharmaceuticals has been criticised by the USFDA for multiple manufacturing faults, including deficiencies in its quality control sys...06 Aug, 2023, 11.25 AM IST
- USFDA red flags Torrent Pharma for violation of norms at Indrad facilityStating that company's investigations into testing results were inadequate, the letter said this is a repeat observation from USFDA's April...17 Oct, 2019, 08.32 PM IST
- FDA pulls up Aurobindo Pharma for 'repeated' failures in CGMPThe FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from CGMP for API.03 Jul, 2019, 06.33 PM IST
- USFDA inspection of Biocon's drug substance unit at Bengaluru completeThe week-long audit concluded without any observations and no Form 483 was issued, it added.24 Sep, 2018, 02.19 PM IST
- USFDA issues warning letter to Fresenius Kabi for Baddi plantThe regulator also asked Fresenius Kabi AG to ensure sufficient investigation of potential vulnerabilities in the manufacturing operation a...03 Jan, 2018, 08.50 PM IST
- USFDA issues warning letter to Lupin's Goa, Indore plantsOn Lupin's Pithampur (Indore) plant, the US health regulator said the company invalidated initial OOS laboratory results without adequate i...16 Nov, 2017, 11.43 PM IST
- USFDA issues warning letter to Megafine Pharma for Vapi plantSummarising significant deviations from CGMP norms at the Vapi unit, the US Food and Drug Administration said that its investigators observ...08 Mar, 2017, 08.57 PM IST
- Making Ranbaxy units cGMP compliant time consuming: Sun PharmaThe company expects to complete the remediation steps in at least one of these facilities in this fiscal, Sun Pharma Managing Director Dili...21 Aug, 2016, 11.18 AM IST
- USFDA warns Sri Krishna Pharma for CGMP norm violationsThe US health regulator said its investigator "identified significant violations of current good manufacturing practice regulations for fin...20 Apr, 2016, 01.10 PM 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
- US FDA cites Apotex's Indian drug facility for fraudulent dataAn Indian subsidiary of Apotex manipulated laboratory data, retesting samples until the results were acceptable, according to a warning let...18 Jun, 2014, 04.40 PM IST
- US Food and Drug Administration continues ban on Sun Pharma's Gujarat plantSun Pharma has 15 days time to reply to the various concerns raised by the FDA related to the plant.20 May, 2014, 10.57 PM IST
- US drug regulator issues warning letter to RPG Life SciencesUSFDA has issued a warning letter to RPG Life Sciences for violation of current good manufacturing practice (CGMP) norms at its two plants ...19 Jun, 2013, 08.40 PM IST
- HCL launches ELM app for pharmaHCL Technologies Ltd has announced the launch of its web-based application 'Equipment Log Manager', designed to cater to the pharmaceutical...31 Aug, 2006, 04.30 PM IST
- HCL launches ELM application for pharma industryLeading IT services provider HCL Technologies Ltd on Thursday announced the launch of its web-based application 'Equipment Log Manager', de...31 Aug, 2006, 04.10 PM IST
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