Hikma, which has established itself as a top sterile injectables manufacturer in the U.S., is now picking up a production plant in Vietnam.
While Mylan’s third-quarter results impressed analysts, the generics drugmaker is still dealing with some significant manufacturing issues.
Pennsylvania-based Recro Pharma has expanded its CDMO manufacturing, adding a 24,000-square-foot facility that includes high-potent processing.
The FDA issued a 22-page, 11-observation Form 483 to Akorn’s Parsippany, New Jersey, plant following a five-week inspection.
With generics expected soon for eye drug Restasis, Allergan has canceled a $200 million expansion at its Waco, Texas, manufacturing plant.
Mylan, Pfizer and the FDA notified U.S. healthcare providers of a potential problem with some EpiPens which can delay treatment.
Merck's RotaTeq won China approval in April and a launch is underway, but meanwhile, the company is reducing its shipments to low-income countries.
Here is some news of note for the week: Apotex is dangling a $10 million reward in its CEO’s murder.
The FDA says a probable cancer-causing ingredient has been found in yet another blood pressure treatment in the U.S.
The FDA continues to find issues with Dr. Reddy’s oncology formulation facility at Duvvada, one of three cited in a warning letter.