The US FDA has published a comprehensive list of facilities that produce Finished Dosage Forms and APIs under the Generic Drug User Fee Act. The list also includes packaging facilities, repackers, analytical testing laboratories and facilities for clinical bioequivalence or bioavailability studies. In total, the list contains 3,652 facilities located in 36 countries including the US.
The list counts 2,515 Finished Dosage Form Facilities (FDF) and API Facilities. Among them, 921 companies produce APIs only and 927 facilities produce APIs as well as FDF (some including Analytical Testing). 667 Facilities manufacture Finished Dosage Forms only.
The list clearly shows that about 70 % of the APIs and FDFs are produced outside of the US. The largest producers outside of the US are India followed by China, Italy, Germany and Canada. India already counts for 23.7% of the API and FDF facilities listed and is by far the largest country exporting to the US. Even China counts for less than a half of the FDF and API facilities exporting to the US, compared to India.
Some facilities haven't paid their annual facility fee yet as required under the GDUFA. Companies who have not paid are facing significant difficulties. The FDA will not be able to process new ANDAs or PASs referencing these facilities. Holders of ANDAs should therefore check whether the facilities (e.g. API manufacturer) mentioned in their current drug application are on the list of facilities. Please also see the list of companies who have not satisfied their annual facility fee.