To market a medicinal product, manufacturing companies need to carry out a head-to-head comparison with its original counterpart, the Reference Listed Drugs (RLDs) or Reference Medicinal Products (RMPs). Referred to as Comparability Exercise, this process focuses on underlying both the parities between generic or biosimilar and reference medicinal products, as well as the disparities in their manufacturing approach. This is an imperative practice to bag authorization from regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) to develop a generic medicine or biosimilar drug.
In other words, Reference Listed Drug (RLD) means a listed drug recognized by regulatory authorities like the FDA or EMA as a medicinal product upon which an applicant may rely in aspiring for approval of an Abbreviated New Drug Application (ANDA). A drug manufacturing company aspiring for approval to market a generic counterpart of a brand name drug must refer to the Reference Listed Drug (RLD) in its ANDA. By designating a single reference listed drug (RLD) as the norm to which all generic version products must be manifested to be bioequivalent, the regulatory authority (FDA) hopes to evade the probable significant contrast among generic medicinal products and their brand name alternatives/counterparts.
If you are searching for a reliable RLD sourcing company in India, and would you like to order reference listed drugs for clinical trials and analytical purposes in the most convenient way? IKRIS Pharma provides worldwide access to reference medicinal products (reference listed drugs/RLDs, comparator drugs) with complete service from sourcing to delivery. We can efficiently source RLD upon the requirements and inquiries given.
We understand to challenge of Reference Listed Drug/RLD sourcing as it requires multiple lots, shelf life, and desired quantities, and to overcome this complex challenge we have an extensive as well as strong network of multiple suppliers/distributors across the world. IKRIS Pharma Network can help to procure the required samples and the relevant deets in a quick and efficient way.