Topic: FDA warning letter
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.
The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying that it did not do enough to test its active ingredients and products before they were shipped to the U.S.
In a warning letter, the FDA shows its dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness.
Dr. Reddy’s Laboratories said regulatory problems with its substitute supplier may keep it from getting to market this quarter with a generic of blockbuster cancer drug Gleevec.
The FDA has caught an Italian drugmaker apparently manipulating testing data, reporting only passing tests even though original reports gave different results.
The FDA cited a skincare product manufacturer in a warning letter for significant violations of cGMP for finished drugs and APIs, along with several misbranding issues.
A Brazilian antibiotics maker that was hammered in an FDA warning letter issued last month also caught the attention of the European Medicines Agency, which has banned its products.
The FDA has issued a warning letter to a Chinese company it found peddling active pharmaceutical ingredients it had not manufactured or tested.
The FDA has come down on an aseptic blow-fill-seal pharma manufacturing operating in Florida that the agency says has widespread issues with microbiological contamination.