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Prescription & OTC Drugs, Active Pharmaceutical Ingredient (API)


Global Drug Market will reach $1.9 Trillion by 2027.

Most global spending growth, in developed markets, will be fueled by significant innovations in oncology, autoimmune and diabetes treatments.

The U.S. will continue as the world’s largest pharmaceutical market, contributing 53 percent of forecasted growth over the next five years, while China, the second largest market, contributing 12 percent of the growth.

The 5 biggest importers are the United States, Germany, Switzerland, China and Belgium, representing 42.5%.

By value, the following 15 countries purchased 70.6% of all prescription drugs and medicines imported:




UNITED STATES $81.9 billion (18.9%)
GERMANY $34.4 billion (7.9%)
CHINA $21.5 billion (4.9%)
SWITZERLAND $25.9 billion (4.7%)
BELGIUM $18.33 billion (4.2%)
FRANCE $18.27 billion (4.2%)
UNITED KINGDOM $18.1 billion (4.2%)
JAPAN $17.3 billion (4%)
NETHERLANDS $11.7 billion (2.7%)
SPAIN $11.6 billion (2.7%)
CANADA $8.7 billion (2%)
RUSSIA $7.2 billion (1.7%)
AUSTRALIA $5.6 billion (1.3%)
POLAND $5.4 billion (1.2%)

Smaller percentages were delivered to Latin America (2.9%) excluding Mexico but including the Caribbean, Africa (2.7%), then Oceania (1.4%) led by Australia and New Zealand.

China has been the largest source of medicine imported into the United States, with India and Mexico vying for second and third.

Drug Imports & Exports Regulations

Any establishment (domestic and foreign) engaged in the manufacture, repacking, relabeling, or salvaging of drugs for commercial distribution in the United States, is required to register with the FDA, and list its products.

Establishment registration and drug listing data are submitted electronically. Parts of the data are published in the

There was a significant increase in overall registered facilities with 6,743 new registrants in 2020, the majority of which were hand sanitizer manufacturers.


FDA Registration


Product Listing


FDA Compliant Labels

FDA relies on establishment registration and drug listing information for:

▪ Drug establishment inspections.

▪ Post market surveillance.

▪ Counterterrorism.

▪ Recalls.

▪ Drug quality reports.

▪ Adverse event reports.

▪ Monitoring of drug shortages and availability.

▪ Supply chain security.

▪ Drug import and export.

▪ Identification of products that are marketed without an approved application.

About 78% of active pharmaceutical ingredient (API) manufacturers are located outside of the United States, and in India among others.
Drugs Misbranding

Here are the main issues:

1. False or Misleading Benefit Presentation.

2. False or Misleading Claims about Efficacy.

3. Omission of Material Fact.

Prescription drug advertisements and labeling (promotional communications) misbrand a drug, if they make false or misleading claims and representations about the risks associated with and efficacy of a drug.

The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.

Promotional communications include:

▪ Emails.

▪ Websites.

▪ Social Media Platforms.

▪ Online Banners.

▪ TV Shows.

▪ Direct-to-consumer broadcast television advertisement (TV Ad or Commercial).

These violations are concerning from a public health perspective, because the promotional communication creates a misleading impression regarding the overall benefit a patient may expect as a result of the treatment, and minimizes the risks associated with taking the drug.

For your information, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) reviews online promotional communication and sponsored links.

Drug Establishment Registration

Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed.

Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing, is misleading and constitutes misbranding.

Furthermore, FDA’s acceptance of registration and listing information, inclusion of a drug in its database of drugs, or assignment of an NDC, does not denote approval of the establishment or the drug or any other drugs of the establishment, nor does it mean that the drug may be legally marketed.

Any representation that creates the impression that a drug is approved or is legally marketable because it appears in the FDA’s database of drugs, has been assigned or displays an NDC, or the establishment has been assigned an establishment registration number or Unique Facility Identifier, is misleading and constitutes misbranding.

Also, failure to register a drug establishment, constitutes misbranding.

Highest volume growth is expected in Latin America, Asia and Africa, driven by a mix of population growth and expanded access.