Topic: FDA warning letter
India’s Lupin has received a warning letter for two of its plants in India, one which it is key to launching new drugs in the U.S.
The FDA has banned the OTC products of a Canadian drugmaker after finding it was using ingredients from a supplier already on its import alert list.
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.