A firm that does not participate in the manufacture or processing of a drug but markets and distributes under its own trade/brand name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.
The private label distributor takes on the responsibility of marketing, branding, and selling the products, while the manufacturer is responsible for producing and supplying the products.
PLDs do not have a registration or listing obligation for drugs since they do not manufacture or process in their facility.
They may elect to submit listing information for a drug they do not manufacture or process directly to the FDA by themselves or if they do not want to list, the manufacturer must submit the drug listings on behalf of the private label distributor.
If the PLD submit the listings under their NDC number, they assume full responsibility for compliance with all listing requirements.
To be a successful private label distributor, it is important to have strong relationships with manufacturers, a clear understanding of market trends and consumer preferences, and effective branding and marketing strategies.
The steps involved in drug listings can be checked at https://www.fdahelp.us/otc-drug-registration-process-fda.html
Liberty Management Group Ltd, provides assistance with drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Email: office@libertymanagement.us