Drugs in Short Supply Excluded From Intas FDA Import Alert
Twenty-five drugs manufactured by Intas Pharmaceuticals have been excluded from an FDA import alert because they are in short supply, the agency wrote in a June 2 import alert letter, banning, however, all other drugs manufactured at the company’s Sanand, India, facility as a result of quality lapses found during a Nov. 22 - Dec. 2, 2022, FDA inspection.
The excluded drugs include atropine, dexmedetomidine, furosemide, amitriptyline and spironolactone. The FDA said it will reconsider this list if shortage and medical necessity implications change.
All other drugs manufactured by Intas are subject to refusal of admission in the U.S. until the company “can demonstrate the drugs manufactured at this site, and intended for the U.S. market, are in compliance with CGMP” the FDA noted.