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.