用于注册申报,中试生产的原料药能卖吗?顺利通过三批验证,用于注册申报的原料药,只要API质量符合制定的质量标准,就可以销售。前提是专利不侵权。 依据(If the pre-established validation criteria are satisfied, drug product from the API “validation batches” can be sold for human use)来源于U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER)查看更多