Reference Listed Drugs for R & D
Reference listed drug (RLD)/Innovator is an FDA approved drug product to which a generic versions are compared to show that they are bioequivalent. A Pharmaceutical company requesting approval to market a generic equivalent (know as Abbreviated new drug application or ANDA) must refer to the RLD in its regulatory submissions. When a pharmaceutical manufacturer is filing an ANDA, they should refer to FDA approved RLD in the application showing that the generic drug is same with respect to the active ingredient(s), dosage form, route of administration, strength, labeling, and importantly bioequivalent to RLD.
Evaum Pharma solutions plays significant role in sourcing Reference listed drugs for the generic pharmaceutical companies/CRO conducting BE studies. Evaum Pharma has professionals with vast pharmaceutical experience specifically in product development (formulation, analytical and regulatory) of NDA, ANDA, and 505 b(2). With the deep understanding of the product development, Evaum Pharma solutions understand the pharmaceutical company’s requirement of specific lot, expiry and urgency of RLD to develop the generic products in limited time to be ahead in the competition.
Leverage our extensive global pharmaceutical manufacturer partnerships to grant your clinical trial team access to genuine, commercially accessible drugs, along with confidential strategic guidance aimed at preventing expensive delays.