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Though the citation is given under (21 CFR 211.160(b)) which is Failure to establish appropriate product specifications and scientifically sound testing procedures

Journal of Cerebral Blood Flow and Metabolism 30(2):255266

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Lipo-C is used to promote body fat reduction and preserve lean muscle tissue

However, biosimilar approval timelines stretch across multiple years, meaning significant price reductions at the brand level are unlikely before 20252026