Pfizer has recalled more than half a million vials of Protonix, its injected gastrointestinal med that has been distinguished in recent years by the litigation…

With GlaxoSmithKline’s vaccines sales expanding, it figures it needs expanded production as well and some of that will happen at a 10-year-old plant in Hungary.

India’s Wockhardt, which now has a record seven FDA warning letters for its plants on three continents, appears to be reaching a breaking point with the agency.

India’s Megafine Pharma has received its second FDA warning letter in 10 months, this one for an API intermediates plant in India.

The FDA and the European Medicines Agency have agreed to recognize the plant inspections each does in their own areas.

Wockhardt has received an untitled letter for a sterile injectables plant in India that Wockhardt is trying to get approved by the FDA to sell into the U.S.

Thanks to some crafty payer negotiating from GSK, even if Advair generics win approval, it may be a while before they gain serious traction, even if it wins…

Allergopharma, the allergy meds unit of Merck KGaA, has opened a new biopharmaceutical production plant near Hamburg.

Manufacturing