API issues delay drug approval

Deficiencies at a manufacturing facility are holding up FDA approval of the antidepressant Trazodone. Labopharm, its maker, says its API manufacturer, Angelini, has said that the FDA concerns are "not critical." Article

Suggested Articles

Fujifilm Diosynth Biotechnologies last year committed 10 billion yen toward its manufacturing operations. It has now kicked off one of those projects.

Popular logic says you never switch horses, or CDMOs, in the middle of the stream, but Acacia Pharma had to do that to win an FDA approval.

The FDA has found issues with the testing practices of a U.S. generics maker that had specific problems with ADHD and weight-loss drugs.