Topic: FDA warning letter
Manufacturing issues at legacy Hospira plants have taken a toll on Pfizer’s earnings and created serious problems for some of its clients.
Dr. Reddy's recalls more meds in the U.S., while the EMA recanted its plant's GMP certificate; China approved a domestic Ebola vaccine.
India-based API maker Vital Laboratories was slapped with a warning letter from the FDA over manufacturing and records issues at its Plant II located in Vapi, Gujarat.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
Amgen inked a biosim deal with Simcere, Gilead won a Chinese nod for Sovaldi, and Shanghai Pharma is in talks to buy part of Alvogen.
The FDA hit Chinese drugmaker Shandong Vianor Biotech with a warning letter and placed the company on an import alert.
The FDA served a warning letter to China’s Wuxi Medical Instrument Factory in response to an inspection that exposed four violations.
South Korean drug manufacturer Firson was slapped with a warning letter and placed on an import alert by the FDA.
The FDA has sent its third warning letter in three months to facilities making homeopathic meds, raising concerns about potentially toxic ingredients.
Takeda and AZ will team up on Parkinson’s candidate, Samsung Bioepis got nod for a Humira copycat and Daiichi Sankyo said AZ buyout is “not the fact.”