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Latest From Bowman Cox
Site switch also could trigger ANDA approvals sidelined as Moraiya plant recovers from US FDA warning letter.
Expert investigators found many problems at Ahmedabad plant, warning letter and Form 483 report show.
Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’
Ranitidine no more carcinogenic than grilled meat, says FDA drug center director Janet Woodcock. Agency finds NDMA levels in ranitidine drugs well below those claimed by Valisure, online pharmacy asking FDA to order drug off US market.
Ranitidine no more carcinogenic than grilled meat, the FDA’s Woodcock says, with NDMA levels well below those claimed by Valisure.
If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.