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 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 issues warning to Shilpa Medicare for CGMP violations at Telangana plant"This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceutica...
Strides plunges 8% as USFDA finds significant violation at facilityThe US drug regulator said it also found a blue binder containing CGMP records.
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 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...
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 ...
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...
'Torn records, ignoring consumer issues at Cadila's 2 plants'Torn notebook with record of 'deficiencies', plastic bags filled with shreds of paperwork, failure to adequately investigate and address co...
Teva Pharmaceutical recalls 38,858 bottles of drugs made by Emcure Pharmaceuticals in US marketThe company is also recalling 7,694 bottles of anti- inflammatory drug indomethacin 25 mg, produced by Emcure Pharma, for non-adherence to ...
Certain consent decree terms to apply to Mohali unit: RanbaxyThe decree contains provisions to ensure CGMP (Current Good Manufacturing Practices) compliance at certain Ranbaxy facilities.
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 pharma
HCL 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 industry
Leading IT services provider HCL Technologies Ltd on Thursday announced the launch of its web-based application 'Equipment Log Manager', de...