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CGMP
Over 67,000 cases of deodorants sold at Walmart, Amazon recalled due to 'cGMP deviations'. What is it?Over 67,000 cases of Power Stick deodorant sold at major retailers like Walmart, Amazon, and Dollar Tree have been voluntarily recalled. Th...- USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad divisionNatco Pharma announced that its Hyderabad-based pharma division received a Form 483 with seven observations from the USFDA following an ins...
- Biocon Biologics' Bengaluru unit classified as voluntary action indicated by USFDABiocon Biologics' drug substance facility in Bengaluru has been classified by the USFDA as voluntary action indicated after a cGMP inspecti...
- 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 ...
- Cipla's Pithampur unit gets 8 observations from USFDA after inspectionThe US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facilit...
- 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.
- 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.
- Panacea Biotec says newly developed vaccine works better than its peersEasySixTM is a fully liquid ready-to-use hexavalent vaccine made using high quality antigens complying to WHO’s cGMP requirements."
- Korea's Mezzion Pharma files suit against Dr Reddy's in USMezzion, which used to be a customer of Dr Reddy's, said it "has incurred delay and expense and was forced to seek new manufacturers and su...
- 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...
- Novartis gets USFDA warning letter for two plants in IndiaSandoz, the generic drug arm of Swiss drug major Novartis, has received a warning letter from the US health regulator for violations of cur...
- Ranbaxy drugs safe says Australian drug regulator"At present, there is no evidence that any of the products in the Australian market manufactured by Ranbaxy are of an unacceptable quality".
- Jubilant arm recalls Pantoprazole Sodium drug from US marketThe US FDA cites the reason of recall as "cGMP deviations, oral products were not manufactured in accordance with good manufacturing practi...
- Sun Pharma Q1 net zooms 244 pc to Rs 564.32 crSun Pharmaceutical Industries today reported a 244.43 per cent jump in net profit at Rs 564.32 crore for the quarter ended June.
- US FDA issues warning letter to Ranbaxy's American subsidiaryThe US Food and Drug Administration issued a warning letter to Ranbaxy Labs' American subsidiary for violating current good manufacturing p...
- St hammers Sun Pharma as USFDA seizes 33 drugs of armUS authorities seized drugs made by Sun Pharmaceuticals’ US subsidiary for violation of manufacturing standards, pushing down share prices ...
- Ranbaxy to market Lisinopril tablets in CanadaRanbaxy Laboratories has got approval from Health Canada, Therapeutic Products Directorate to manufacture and market Lisinopril 5, 10 and 2...
- Ajanta Pharma out-licences product technology to TaiwanAjanta Pharma Ltd will out-licence technology of its anti-scar product 'Vaniza' to Orient Europharma of Taiwan.
- 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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