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CGMP INSPECTION
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...- Emcure Pharma gets Form 483 with two observations for API plant from USFDAEmcure Pharmaceuticals received two observations from the USFDA after an inspection of its Pune API facility. The company is addressing the...
- 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 issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unitA routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurk...
- Jubilant gets VAI classification from USFDA for Roorkee unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- 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 inspection of Unichem Lab's Roha facility completed with no observationDrug firm Unichem Laboratories on Monday said the US health regulator has completed inspection of its Roha facility in Maharashtra without ...
- JB Chemicals Gujarat unit passes USFDA inspection with one observationThis observation does not impact continuity of the business and the company would continue its manufacturing activities in current good man...
- Cipla recovers after falling 5% on fears of action against Goa unitObservations are largely related to procedure and SOP lapses, Equirius said.
- Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDAThe FDA conducted a cGMP (Current Good Manufacturing Practices) inspection at the Unit 7 manufacturing facility from September 19-27 this y...
- 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.
- Lupin gets EDQM nod for its Mandideep facilityThe inspection was focused on the application for certificate of suitability for the dossier of Cefaclor along with facility inspection for...
- Zydus Cadila shares rise 3.41% after USFDA clears Moraiya plantThe USFDA inspected Cadila’s Moraiya facility from August 31-September 7.
- Suven Life receives Establishment Inspection Report from USFDASuven Life Sciences said so far it has filed 19 DMF's and 4 ANDA's from its plant near Hyderabad which is FDA complaint.
- EIC, USFDA ink pact to share information on import alertsThe pact would "allow EIC (Export Inspection Council) to conduct quick cause analysis in time to support the Indian exporter," the commerce...
- 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".
- 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...
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