Tuesday, June 16, 2015

FDA Regulations for API

written by: FDA regulatory specialist Published on 6-6-2015

What is API

Active Pharmaceutical Ingredient is a product which is not intended to consume directly by human.
Drugs which does not have enough information on the label regarding how to consume is also considered as API.
API are involved in the manufacturing of finished drugs.

Regulations for API with FDA

All domestic and foreign API Manufacturers have to register their facility or establishment with FDA.
All API should possess a NDC number which is unique for each API.
All API imported inside US must be listed with FDA.
Self-Identification is required for all domestic and foreign facility where API for generic drug is manufactured.
All foreign API manufacturers should have an U.S.Agent.

 Services provided by LMG for API manufacturers.

LMG assists API manufacturer to electronically submit Self-identification, facility registration, NDC labeler code and drug listing.

LMG provides US Agent service for foreign API manufacturers.

FDA CERTIFICATE OF FREE SALE

Certificate of Free sale, which is also known as FDA Export Certificate is a document which certifies that the product manufactured in US is eligible for export. This certificate states that there are no overheads or pending impulsive actions on the manufacturer. This is a document which contains information about a product’s regulatory and marketing status.
           This Certificate of free sale or export certificate is needed by many foreign governments because they want to ensure that the products marketed in their country comply with US FDA regulations. This is issued by the FDA upon request by the manufacturer which meet the FDA regulations. 
           The certificate of free sale is for food including dietary supplements and cosmetics. FDA export certificate is for human drugs, animal drugs and medical devices that meet up with the FDA standards and the manufacturers should follow the cGMP.
       FDA will not issue the Certificate of free sale or export certificate, if the product is not exported from US. Manufacturers has to register their facility with FDA before they apply for the Certificate of free sale from FDA.

Liberty Management Group Ltd, US based leading FDA Consulting group can guide you through the export certificate request process, which will help you to get the process easier. LMG also provide assistance with facility registration with FDA.

written by : FDA Registration Specialist, LMG
Published on : 6-16-2015