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CGMP COMPLIANCE
USFDA pulls up Jagsonpal Pharmaceuticals for manufacturing lapses at API plantThe USFDA has issued a warning to Jagsonpal Pharmaceuticals following an inspection of its API plant in Rajasthan. The regulator highlighte...- Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at a...
- USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plantIn a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufac...
- 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...
- 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 ...
- 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...
- 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...
- 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.
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- 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 ...
- 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...
- 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...
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