ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:

■ Drug Establishment Registration

■ Drug Product Listing

■ Investigational New Drug (IND) Application

■ New Drug Application (NDA)

■ Abbreviated New Drug Application (ANDA): Generics

■ U.S. Agent Service

■ Label Review

■ Label Design

Any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA. There are exemptions.

FDA defines drugs as

a substance recognized by an official pharmacopoeia or formulary.
a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
a substance (other than food) intended to affect the structure or any function of the body.
a substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

FDA’s Center for Drug Evaluation and Research (CDER) regulates

■ Over-the-counter and prescription drugs including biological therapeutics and generic drugs

■ Fluoride toothpaste, antiperspirants, dandruff shampoos, sunscreens, hand sanitizers that are considered “drugs“

■ Prescription Drugs: medicines or any drug product that requires a doctor’s authorization for purchase

■ Generic Drugs: drug products equivalent to brand name products in terms of quality and performance. A generic drug product is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

■ Over-the-Counter (OTC) Drugs: drug products are available to consumers without a doctor’s prescription.

All Drug Establishments must renew their registration between October 1 and December 31, 2020.