Electronic submission: Most registration takes place electronically via the FDA Unified Registration and Listing System (FURLS). Information Needed: General information about the facility, such as its name, address, operation type, and specific drugs made or handled. Renewal: Registration must be renewed each year at the end of the calendar year from October 1st-December 31st. NDC XML Submissions: Objective: The National Drug Code (NDC) is a unique identifier assigned to each drug product marketed in the United States. It is a unique identifier for products as they move through the commercial distribution chain. Components of the NDC Labeler Code: Assigned by the FDA to the manufacturer, repackages, or distributor of the drug product. Product Code: Unique to each strength, dosage form, and formulation of the product. Package Code: Identifies the specific package size and type. Submission Method NDC information is submitted electronically, typically via the FDA’s Electronic Submissions Gateway (ESG) or other approved electronic submission platforms. Use and Requirements NDC submissions are mandatory for: New drug products entering the market Updates to existing products Maintaining accurate and up-to-date drug listings with the FDA

ER,NDC,XML SUBMISSIONS - PharmReg Neoteric

Q: Integration and Compliance

Regulatory Compliance: FDA regulations also require the submission of both ER and NDC information. These submissions maintain proper registration of pharmaceutical establishments and accurate identification and listing of drug products to be distributed in the United States. Electronic Submission: Electronic filing of ER and NDC submissions improves accuracy, efficiency, and consistency in regulatory reporting, allowing the process to run more smoothly and dependably.

ER NDC XMLSubmissions are FDA regulated submissions for the pharmaceutical industry in the United States.

Objective: The establishment registration (ER) process registers a pharmaceutical establishment with FDA. This registration is required for any facility that is using drugs for commercial distribution within the United States by manufacturing, processing, packing, or holding drugs.

Who Must Register: All domestic and foreign establishments that manufacture or process drugs or biologics for commercial distribution (i.e., drug or biologics is intended for commercial distribution in the United States) must register with the FDA. This includes those manufacture, repackage, relabel, and those that produce active pharmaceutical ingredients (APIs).

Registration Process

Electronic submission: Most registration takes place electronically via the FDA Unified Registration and Listing System (FURLS).
Information Needed: General information about the facility, such as its name, address, operation type, and specific drugs made or handled.
Renewal: Registration must be renewed each year at the end of the calendar year from October 1st-December 31st.
NDC XML Submissions:
Objective: The National Drug Code (NDC) is a unique identifier assigned to each drug product marketed in the United States. It is a unique identifier for products as they move through the commercial distribution chain.
Components of the NDC
1. Labeler Code: Assigned by the FDA to the manufacturer, repackages, or distributor of the drug product.
2. Product Code: Unique to each strength, dosage form, and formulation of the product.
3. Package Code: Identifies the specific package size and type.
Submission Method
NDC information is submitted electronically, typically via the FDA’s Electronic Submissions Gateway (ESG) or other approved electronic submission platforms.
Use and RequirementsNDC submissions are mandatory for:

New drug products entering the market
Updates to existing products
Maintaining accurate and up-to-date drug listings with the FDA

Integration and Compliance

Regulatory Compliance:
FDA regulations also require the submission of both ER and NDC information. These submissions maintain proper registration of pharmaceutical establishments and accurate identification and listing of drug products to be distributed in the United States.
Electronic Submission:
Electronic filing of ER and NDC submissions improves accuracy, efficiency, and consistency in regulatory reporting, allowing the process to run more smoothly and dependably.