Drugs

Slight Drop in Number of Drug Manufacturing Sites: Report

The just-released CDER FY 2020 “State of Pharmaceutical Quality” report shows a slight decrease in the number of drug manufacturing sites from 4,273 in FY 2019 to 4,221 in FY 2020. The count excludes medical gas manufacturers and newly-registered hand sanitizer manufacturers, the report says.

Some 38% of the manufacturing sites are in the “no application” sector, meaning that all products manufactured at the facilities are those marketed without an approved application, including over-the-counter monograph products, unapproved products, and homeopathic products. The remaining 62% of the sites are involved in the manufacture of at least one application product, whether under a BLA, NDA, or ANDA.

As in previous years, CDER says, there are more sites involved in the manufacture of both innovator and generic products (1,093) than there are sites involved in the manufacture of either innovative (494) or generic (609) products exclusively.

The top five countries by the number of manufacturing sites in the FY 2020 CDER site catalog were the U.S., India, China, Germany, and Canada. All had a net decrease in the number of sites, the report says, and they were the same top five countries as in FY 2019.

The report says the number of Warning Letters issued in FY 2020 was slightly lower than in FY 2018 or FY 2019, but still over four times higher than in FY 2015. As in past years, the majority of Warning Letters in FY 2020 were issued to sites with non-application products (69%), and especially those that manufacture finished dosage form, non-sterile, non-application products (41% of all Warning Letters).

Import Alerts doubled to 128 in FY 2020, CDER says, and Latin America had the most sites on Import Alert for the first time due to an unprecedented number of new hand sanitizer registrants from Mexico that failed to meet quality standards.

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