According to FDA, an active pharmaceutical ingredient is defined as “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease or to affect the structure and function of the body.”
API is the part of a drug that creates its effectiveness. In some cases, for example in combination therapies there may be multiple active ingredients to treat different symptoms in various ways.
All drugs are manufactured with two main components one: the API which is the main ingredient and others are called inactive ingredients also known as excipients which helps to deliver the medication into the system. Inactive ingredients are components of a drug product that do not surge or affect the medicinal action of the active ingredients. Inactive ingredients are added during the manufacturing process of the pharmaceutical products. Even though inactive ingredients don’t have any therapeutic effects, they are important and necessary components for any medication which plays an important role in drug composition, absorption, delivery and much more.
Manufacturers are using certain standard to determine the potency of the API in each drug. However it varies from one manufacturer to another. But all the manufacturers are required to register their manufacturing establishment with FDA and prove the effectiveness of their drugs through clinical trials.
Under Section 510 of FD&C Act, all firms that manufacture or processing of human drugs are required to register with FDA. The “manufacture” includes the manufacture, prepare and propagation drugs, drug compounding or processing of a drug. The scope of drug manufacturing include drug analysis, active pharmaceutical ingredient (API), final dosage form (FDF), analytical testing, repackaging or relabeling of any drug.
All API manufacturers are required to register their establishment and list their drugs with FDA. API drug manufacturers needs to submit their registration to FDA through Electronic Submission Gateway (ESG) by creating Structured Product Labeling (SPL) files API manufacturer’s drug establishment registration can be verified at https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm and listing can be verified at https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm
Liberty Management Group Ltd, provides assistance with API drugs establishment registration, NDC labeler code request, Drug listings and US agent service to foreign facilities.
Sudha S
Regulatory Consultant
Mail: office@libertymanagement.us