The FDA (U.S. Food and Drug Administration) requires drug manufacturers to submit a “blanket listing submission” for all drug products they manufacture. This listing includes information about the drug products and the facilities where they are manufactured.
A blanket listing submission is a process by which pharmaceutical companies provide the FDA with a comprehensive list of all drug products they manufacture. This includes prescription and over-the-counter drugs.
FDA uses this information to monitor and regulate drug products in the United States. It helps the FDA track the availability and safety of drug products, as well as identify manufacturing facilities and labeler codes associated with these products.
Drug manufacturers must submit/update listing every year between October 1st and December 31st even if no changes have occurred.
The submission typically includes detailed information about each drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and National Drug Code (NDC) number. It also includes details about the manufacturing facilities and labeling information.
The FDA now requires electronic submission of these listings through the FDA’s Electronic Submissions Gateway (ESG) in Structured Product Labeling (SPL) format.
Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.
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
office@libertymanagement.us