USFDA pulls up Lantech Pharma for manufacturing violations at Andhra plant
The significant violations included the failure of the quality unit to ensure that quality-related complaints were investigated…
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CGMP
Indoco Remedies gets warning letter from USFDA for oral dosages plant in Goa
The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the…
FDA pulls up Aurobindo Pharma for ‘repeated’ failures in CGMP
The FDA recently issued a letter warning the drug- makers unit X1 in Srikakulam district of Andhra Pradesh for deviations from…
Marksans Pharma arm recalls Ibuprofen tablets from US
According to the US FDA, the nationwide, voluntary and ongoing recall is a Class II recall
Govt mulls setting up of CGMP facility for yellow fever drugs
According to the health minister, such a facility will help in supplying yellow fever vaccine to African and Latin American…
US FDA warns of serious data integrity violations at DRL
The US Food and Drug Administration has warned DRL over serious data integrity violations, placing all its new applications or…
US FDA issues warning letter to Mylan
Inspectors found 'significant violations' in the three manufacturing facilities in Bengaluru
The US Food & Drug…