Amneal Pharmaceuticals, Inc.
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Latest From Amneal Pharmaceuticals, Inc.
Amneal says an $83.5m deal to acquire Saol Therapeutics’ baclofen franchise will also bring the firm an “experienced institutional commercial team” that will be able to support three biosimilar launches that the company now expects to execute in 2022.
The agency offers ‘regulatory flexibility’ for certain requirements of the iPLEDGE REMS for the acne drug if manufacturers address delays in implementing the modified program.
After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.
FDA officials outline the impact of using alternative tools to assess manufacturing facilities amid COVID-19 and share key experiences around these, including with remote interactive evaluations.
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