U.S. FDA Observation Trends

U.S. FDA Domestic vs. Foreign Compliance Actions (Drug Quality Assurance) 2009 – Current*

9873 Compliance Actions U.S.A.

2468 - 9873 Compliance Actions Canada, UK, Spain, France, Germany, India, China, Australia, Taiwan, Indonesia, Japan

987 - 2468 Compliance Actions Mexico, Brazil, Sweden, Denmark, Netherlands, Switzerland, Israel, Vietnam, Malaysia, Philippines

% Predominant Overseas Active Pharmaceutical Ingredients (API) Contributors to the US Market in 2018

• India 31%
• EU Countries 31%
• China 14%
• USA 12%
• Rest of World 11%
• Latin America 2%

India was # 1 Overseas FDF Contributor in 2018.

Predominant Overseas Finished Dosage Forms (FDF) Contributors - 2018 as reported by the U.S. FDA Drug Shortage Task Force 2019.

• India (24%)
• EU Countries (18%)
• China (8%)
• Canada (4%)

Regional Distribution of Facilities Manufacturing Finished Dosage Forms (FDF) in 2018. These numbers apply to manufacturers named in approved applications. Medical gas, compounding, pending application, and non-application (OTC) facilities are excluded. Percentages have been rounded.

All drug manufacturing sites for the U.S. market by country for FY 2018*

• 1: U.S. (39% Sites)
• 2: India (12%) Sites
• 3: China (11%) Sites
• 4: Germany & South Korea (4%) Sites

Drug Quality Inspections for Manufacturing Sites for FY 2018 by Country*

• 1: U.S. (47%)
• 2: India (13%)
• 3: China (9%)
• 4: Germany (4%)
• 5: Canada, Japan, and Italy (3%)
• 6: South Korea, France, Switzerland (2%)