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# FDA Unit Reports ‘High State of Pharmaceutical Quality’
- URL: https://www.fdaweb.com/fda-unit-reports-high-state-of-pharmaceutical-quality/
- Published: 2022-08-25T12:00:00.000Z
- Updated: 2026-09-14T17:57:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152586

The CDER Office of Pharmaceutical Quality (OPQ) FY 2021 annual report says the data and analyses in the report “provide a picture of a high state of pharmaceutical quality for U.S. consumers and patients with the expectation for continuing improvement.” The [report](https://www.fda.gov/media/161172/download?utm%5Fmedium=email&utm%5Fsource=govdelivery) contains key data used to characterize drug and site quality for consumers and patients in the U.S. and covers FDA-registered drug manufacturers and drugs regulated by CDER.

OPQ says the FY 2021 CDER Site Catalog lists 4,451 drug manufacturing sites, a 3% increase over FY 2018\. Of the total manufacturing sites, 39% are in the “No Application” sector, meaning that all the products they manufacture are marketed without an approved FDA application.

The top five countries based on the number of sites in the inventory were the U.S., India, China, Germany, and Canada. OPQ says they all had net increases, based on new registrations and removals, in the number of manufacturing sites over the last three years.

“Understanding the locations of drug manufacturing sites and their trends helps FDA better plan for future surveillance and outreach,” the report says.

For FY 2021, the CDER Product Catalog contained 12,428 ANDAs, 3,537 NDAs, and 315 BLAs. The catalog also has more than 140,000 non-application products with a unique National Drug Code.

The report also has information on product quality defects, import alerts and recalls, research on the state of quality, and commitment to quality.