The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to drugmakers in Australia and Korea over good manufacturing practice (GMP) violations and warned the operators of more than 50 websites for illegally selling unapproved opioids.
IDT Australia Receives FDA Warning Letter
IDT Australia Ltd`s Generic Temozolomide approved in US as chemotherapy drug
ANI Pharmaceuticals, Inc. has entered an agreement with IDT Australia, Ltd. to commercialize as many as 18 marketed U.S. generic drug products. ANI paid $1.0 million for exclusive rights to the North American market and will share in a percentage of profits upon commercialization. The total current annual U.S. market for these products is $538 million according to IMS Health. - See more at: http://www.contractpharma.com/contents/view_breaking-news/2015-08-12/ani-idt-ink-us-generic-commercialization-pact/?utm_source=twitterfeed&utm_medium=twitter&utm_campaign=Feed%3A+ContractPharmaBreakingNews+%28Contract+Pharma+Breaking+News%29#sthash.iYNx07bj.dpuf