Topic: FDA warning letter
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.
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.
Novartis may face more furor in Korea, Astellas will develop a Prevnar rival with Affinivax, and Lilly and Chi-Med's colorectal cancer med aims for an NDA in China.
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.
China updated national drug list with some blockbuster Western meds, Daiichi and ArQule’s tivantinib failed another trial, Dr. Reddy's got an FDA Form 483.
The Pfizer fill-finish plant whose manufacturing problems have gut-punched the expected approval of a generic of Teva’s long-acting Copaxone is a former Hospira plant with a history of issues.
Zhejiang Bangli Medical Products, a medical dressing manufacturer in China, received a warning letter for limiting an FDA inspection.
The impending approval of Momenta's copy of Teva’s long-acting version of blockbuster Copaxone is now expected to be delayed.
PRA and Takeda are building a Japan JV, Sun's quarterly profits dropped, ASLAN posted positive top-line phase 2 data for varlitinib.