Regulatory AMRI Status
DMF Submission expected on 2022
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Regarding APIs under patent protection, could be provided by Curia only for the sole purpose of conducting the required trials and tests to apply for the Marketing Authorization from the Health Authorities as well as obtain the samples required by mentioned Authorities for the purposes of Article 10.6 of the directive 2001/83 EC as amended by the Directive 2004/27/EC. In this respect, these APIs are sold to be used exclusively for these purposes.