The FDA said in a warning letter that an Indian API maker had not ensured that water it gets from a nearby river is sanitary before using it to make its…
FDA inspectors began rolling through the plants of India’s Alkem Laboratories last year and have now found issues with a third Alkem facility.
Sun Pharma has worked its way out from underneath an FDA ban on a plant it got in its 2015 buyout of Ranbaxy Laboratories.
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.
India’s Wockhardt has received an FDA warning letter for a plant in the U.S., making an even half-dozen warning letters for seven Wockhardt plants, three of…
Akorn has gotten the all-clear from the FDA for its sterile manufacturing site in Decatur, Illinois, that was cited in a Form 483 last year.
The FDA has sent Pfizer a warning letter for a former Hospira plant in McPherson, Kansas, for repeating some of the mistakes noted in earlier warning letters.