Countries Manufacturing Pharmaceuticals for the US Market: A 10-Year Analysis of Public Data.

Background: Concerns about strategic supplies and quality have increased the scrutiny of the countries where US pharmaceuticals are made.

Objective: To examine the locations of manufacturers of brand name, biological, and generic drugs over 10 years.

Methods: This longitudinal descriptive study used publicly available data from US government Web sites, including the Food and Drug Administration (FDA) Drug Establishments list, FDA National Drug Code Directory, FDA Orange Book, FDA Purple Book, and the National Institutes of Health DailyMed Drug Labels.

Site-Specific and Country-of-Origin Labeling for Pharmaceutical Manufacturing.

There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the quality of pharmaceuticals. Recalls and import bans shake confidence in medications, particularly for active pharmaceutical ingredients and finished dosage forms made outside the United States.