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I., Redondo-Flrez, L., Martn-Rodrguez, A., & Tornero-Aguilera, J

Yes, and this is the standard approach

Submit the required documentation along with a clear explanation of why you believe the denial should be overturned

Whether this chemical synthesis route produces a product that is therapeutically identical in all patients remains a question that regulators and post-market pharmacovigilance will continue to monitor