Evidentic offers repackaged finished pharmaceutical products known as drug aliquots. The abbreviation RMP – Reference Medicinal Products or Reference listed drug (US: RLD) refers to a commercially available and patent-protected original drug. We refer to the RMP products repackaged by Evidentic synonymously as ‘drug aliquots’ (DA) or aRMP (=analytical RMP).
Procurement of original drug products (RMP).
As ‘raw material’ for the production of DA, Evidentic sources RMP from the European (EU) market. As a licensed pharmaceutical wholesaler, Evidentic is committed to Good Distribution Practice (GDP) compliance with respect to the procurement, storage and shipment of RMP.
Production of drug aliquots (DA/aRMP) from RMP
DA are manufactured by repackaging RMP in a qualified laboratory. The DA manufacturing process is performed under a quality and manufacturing agreement between Evidentic and the contract manufacturer. Repackaging of RMP includes the following steps: opening the secondary and primary RMP containers and transferring the specified volumes of RMP into an Eppendorf 0.5 ml low-binding (or similar) tube. If the RMP is a lyophilized powder and not a highly concentrated solution, reconstitute the RMP according to the original manufacturer’s instructions and then aliquot as a highly concentrated solution.
Labeling of DA/aRMP
For identification purposes, DAs are labeled with the date of aliquoting, the original lot number of the RMP, the original expiration date of the RMP, the name of the active ingredient (INN), and a unique identification code.
Storage of DA/aRMP
Immediately after aliquoting, DAs are stored at either 2-8°C or -86°C for long-term storage. All DAs stored at 2-8°C are brought to -86°C after reaching the expiration date of the original RLD/RMP.
No further quality or functional testing will be performed on the DAs.