In FDA jargon, RLD stands for Reference Listed Drug. Let’s throw a couple of more familiar acronyms in the mix: NDA, stands for New Drug Application and ANDA which stands for Abbreviated New Drug Application. To carry it absolutely simple we could consider the New Drug Application holder as the “Brand” manufacturer and Abbreviated New Drug Application holders as “Generic” manufacturers. For an Abbreviated New Drug Application to be approved, the generic manufacturer has to establish that its drug is bioequivalent to the brand name drug.
So, where does the RLD come in? It is exactly what it sounds like. It is the drug to which an Abbreviated New Drug Application applicant must “reference” for purposes of application submission and approval. The Abbreviated New Drug Application/generic drug manufacturer points to the Reference Listed Drugs and tells the Food and Drugs Administration, I want to be like that. Now so long as the brand name product is still on the market, the New Drug Application holder and the Reference Listed Drugs holder are one and the same.
There is huge global demand for generic drug alternatives. In order to take advantage of this, Ikris Pharma Network helps you in procuring Reference Listed Drugs (RLDs) for your in-vivo bioequivalence studies.
Ikris Pharma Network specifically is a single stop platform for all your needs of innovator samples (single batch/multiple batches of specific quantities) for clinical trials as well as bio-equivalence studies.
We specialize in order to source Reference Listed Drugs (RLDS)/ Innovator samples from across the globe, including India, USA, Europe, Canada, Australia, New Zealand, korea, Japan, and Latin America.
Our globally established supplier network enables us to procure, store (according to the specification of the product) and supply the products from all the major pharmaceutical manufacturers and authorized distribution channels to and from any locations across the world, specific products or product sets in a bit huge volumes. We only deal with approved sources and validated supply chains.
We have partnered with finest logistics as well as courier partners which enable us to efficiently get your RLDs to you on or ahead of time.